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1.  How can insulin initiation delivery in a dual-sector health system be optimised? A qualitative study on healthcare professionals’ views 
BMC Public Health  2012;12:313.
Background
The prevalence of type 2 diabetes is increasing at an alarming rate in developing countries. However, glycaemia control remains suboptimal and insulin use is low. One important barrier is the lack of an efficient and effective insulin initiation delivery approach. This study aimed to document the strategies used and proposed by healthcare professionals to improve insulin initiation in the Malaysian dual-sector (public–private) health system.
Methods
In depth interviews and focus group discussions were conducted in Klang Valley and Seremban, Malaysia in 2010–11. Healthcare professionals consisting of general practitioners (n = 11), medical officers (n = 8), diabetes educators (n = 3), government policy makers (n = 4), family medicine specialists (n = 10) and endocrinologists (n = 2) were interviewed. We used a topic guide to facilitate the interviews, which were audio recorded, transcribed verbatim and analysed using a thematic approach.
Results
Three main themes emerged from the interviews. Firstly, there was a lack of collaboration between the private and public sectors in diabetes care. The general practitioners in the private sector proposed an integrated system for them to refer patients to the public health services for insulin initiation programmes. There could be shared care between the two sectors and this would reduce the disproportionately heavy workload at the public sector. Secondly, besides the support from the government health authority, the healthcare professionals wanted greater involvement of non-government organisations, media and pharmaceutical industry in facilitating insulin initiation in both the public and private sectors. The support included: training of healthcare professionals; developing and disseminating patient education materials; service provision by diabetes education teams; organising programmes for patients’ peer group sessions; increasing awareness and demystifying insulin via public campaigns; and subsidising glucose monitoring equipment. Finally, the healthcare professionals proposed the establishment of multidisciplinary teams as a strategy to increase the rate of insulin initiation. Having team members from different ethnic backgrounds would help to overcome language and cultural differences when communicating with patients.
Conclusion
The challenges faced by a dual-sector health system in delivering insulin initiation may be addressed by greater collaborations between the private and public sectors and governmental and non-government organisations, and among different healthcare professionals.
doi:10.1186/1471-2458-12-313
PMCID: PMC3533841  PMID: 22545648
Insulin initiation; Dual-sector health system; Malaysia; Diabetes; Public sector; Private sector
2.  What are the barriers faced by patients using insulin? A qualitative study of Malaysian health care professionals’ views 
Background
Patients with type 2 diabetes often require insulin as the disease progresses. However, health care professionals frequently encounter challenges when managing patients who require insulin therapy. Understanding how health care professionals perceive the barriers faced by patients on insulin will facilitate care and treatment strategies.
Objective
This study explores the views of Malaysian health care professionals on the barriers faced by patients using insulin.
Methods
Semi-structured qualitative interviews and focus group discussions were conducted with health care professionals involved in diabetes care using insulin. Forty-one health care professionals participated in the study, consisting of primary care doctors (n = 20), family medicine specialists (n = 10), government policymakers (n = 5), diabetes educators (n = 3), endocrinologists (n = 2), and one pharmacist. We used a topic guide to facilitate the interviews, which were audio-recorded, transcribed verbatim, and analyzed using a thematic approach.
Results
Five themes were identified as barriers: side effects, patient education, negative perceptions, blood glucose monitoring, and patient adherence to treatment and follow-up. Patients perceive that insulin therapy causes numerous negative side effects. There is a lack of patient education on proper glucose monitoring and how to optimize insulin therapy. Cost of treatment and patient ignorance are highlighted when discussing patient self-monitoring of blood glucose. Finally, health care professionals identified a lack of a follow-up system, especially for patients who do not keep to regular appointments.
Conclusion
This study identifies five substantial barriers to optimizing insulin therapy. Health care professionals who successfully identify and address these issues will empower patients to achieve effective self-management. System barriers require government agency in establishing insulin follow-up programs, multidisciplinary diabetes care teams, and subsidies for glucometers and test strips.
doi:10.2147/PPA.S36791
PMCID: PMC3559078  PMID: 23378747
primary care; focus groups; noncommunicable disease; diabetes; insulin; qualitative study
3.  Factors influencing insulin acceptance among type 2 diabetes mellitus patients in a primary care clinic: a qualitative exploration 
BMC Family Practice  2013;14:164.
Background
Many Type 2 Diabetes Mellitus (T2DM) patients refuse insulin therapy even when they require this modality of treatment. However, some eventually accept insulin. This study aimed to explore the T2DM patients’ reasons for accepting insulin therapy and their initial barriers to use insulin.
Methods
This qualitative study interviewed twenty-one T2DM patients at a primary care clinic who had been on insulin for more than a year through three in-depth interviews and three focus group discussions. A semi structured interview protocol was used and the sessions were audio-recorded. Subsequently, thematic analysis was conducted to identify major themes.
Results
The participants’ acceptance of insulin was influenced by their concerns and beliefs about diabetes and insulin. Concerns about complications of poorly controlled diabetes and side effects of other treatment regime had resulted in insulin acceptance among the participants. They also had a strong belief in insulin benefits and effectiveness. These concerns and beliefs were the results of having good knowledge about the diabetes and insulin, experiential learning, as well as doctors’ practical and emotional support that helped them to accept insulin therapy and become efficient in self-care management. These factors also allayed their negative concerns and beliefs towards diabetes and insulin, which were their barriers for insulin acceptance as it caused fear to use insulin. These negative concerns were related to injection (self-injection, needle phobia, injection pain), and insulin use (inconvenience, embarrassment, lifestyle restriction, negative social stigma, and poor self-efficacy), whereas the negative beliefs were 'insulin could cause organ damage’, 'their diabetes was not serious enough’, 'insulin is for life-long’, and 'insulin is for more severe disease only’.
Conclusions
Exploring patients’ concerns and beliefs about diabetes and insulin is crucial to assist physicians in delivering patient-centered care. By understanding this, physicians could address their concerns with aim to modify their patients’ misconceptions towards insulin therapy. In addition, continuous educations as well as practical and emotional support from others were found to be valuable for insulin acceptance.
Trial registration
Universiti Kebangsaan Malaysia FF-214-2009.
doi:10.1186/1471-2296-14-164
PMCID: PMC4231611  PMID: 24164794
Type 2 diabetes mellitus; Insulin; Insulin resistance; Qualitative research
4.  Factors affecting the motivation of healthcare professionals providing care to Emiratis with type 2 diabetes 
JRSM Short Reports  2013;4(2):14.
Objective
We aimed to identify facilitators of and barriers to healthcare professionals' motivation in a diabetes centre in the United Arab Emirates (UAE).
Design
A qualitative research approach was employed using semistructured interviews to assess perception of and attitudes regarding healthcare professionals' motivation in providing good quality diabetes care.
Setting
A diabetes centre located in Abu-Dhabi, UAE.
Participants
Healthcare professionals including specialist physicians, dieticians, podiatrists, health educators and nurses were recruited through purposive sampling.
Main outcome measures
After data collection, the audiotaped interviews were transcribed verbatim and subjected to content analysis.
Results
Nine semistructured interviews were conducted with healthcare professionals of various professional backgrounds. Important facilitators and barriers related to patient, professional, organization and cultural factors were identified. Barriers that related to heavy workload, disjointed care, lack of patient compliance and awareness, and cultural beliefs and attitudes about diabetes were common. Key facilitators included the patient's role in achieving therapeutic outcomes as well as compliance, cooperation and communication.
Conclusion
This qualitative study provides some unique insights about factors affecting healthcare professionals' motivation in providing good quality care. To improve the motivation of healthcare professionals in the management of diabetes and therefore the quality of diabetes care, several steps are needed. Importantly, the role of primary care should be reinforced and strengthened regarding the management of type 2 diabetes mellitus, privacy of the consultation time should be highly protected and regulated, and awareness of the Emirate culture and its impact on health should be disseminated to the healthcare professionals providing care to Emirates with diabetes. Also, greater emphasis should be placed on educating Emiratis with diabetes on, and involving them in, the management of their condition.
doi:10.1177/2042533313476419
PMCID: PMC3591689  PMID: 23476735
5.  Considering quality of care for young adults with diabetes in Ireland 
Background
Research on the quality of diabetes care provided to young adults with Type 1 diabetes is lacking. This study investigates perceptions of quality of care for young adults with Type 1 diabetes (23–30 years old) living in the Republic of Ireland.
Methods
Thirty-five young adults with Type 1 diabetes (twenty-nine women, six men) and thirteen healthcare professionals (ten diabetes nurse specialists, three consultant Endocrinologists) were recruited. All study participants completed semi-structured interviews that explored their perspectives on the quality of diabetes services in Ireland. Interviews were analyzed using standard qualitative thematic analysis techniques.
Results
Most interviewees identified problems with Irish diabetes services for young adults. Healthcare services were often characterised by long waiting times, inadequate continuity of care, overreliance on junior doctors and inadequate professional-patient interaction times. Many rural and non-specialist services lacked funding for diabetes education programmes, diabetes nurse specialists, insulin pumps or for psychological support, though these services are important components of quality Type 1 diabetes healthcare. Allied health services such as psychology, podiatry and dietician services appeared to be underfunded in many parts of the country. While Irish diabetes services lacked funding prior to the recession, the economic decline in Ireland, and the subsequent austerity imposed on the Irish health service as a result of that decline, appears to have additional negative consequences. Despite these difficulties, a number of specialist healthcare services for young adults with diabetes seemed to be providing excellent quality of care. Although young adults and professionals identified many of the same problems with Irish diabetes services, professionals appeared to be more critical of diabetes services than young adults. Young adults generally expressed high levels of satisfaction with services, even where they noted that aspects of those services were sub-optimal.
Conclusion
Good quality care appears to be unequally distributed throughout Ireland. National austerity measures appear to be negatively impacting health services for young adults with diabetes. There is a need for more Endocrinologist and diabetes nurse specialist posts to be funded in Ireland, as well as allied health professional posts.
doi:10.1186/1472-6963-13-448
PMCID: PMC3883518  PMID: 24168159
Type 1 diabetes; Quality of care; Young adult; Emerging adult; Ireland
6.  Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol 
Background
Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.
Methods
This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c ≥7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice.
Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.
Discussion
The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.
Trial registration
Australian and New Zealand Clinical Trials Registry ACTRN12612001028897
doi:10.1186/1748-5908-9-20
PMCID: PMC3930818  PMID: 24528528
Type 2 diabetes; Primary care; Nursing; Randomized trial; Insulin; Implementation; Australia; Health services research
7.  Barriers and facilitators to self-monitoring of blood glucose in people with type 2 diabetes using insulin: a qualitative study 
Background
Self-monitoring of blood glucose (SMBG) helps to improve glycemic control and empowerment of people with diabetes. It is particularly useful for people with diabetes who are using insulin as it facilitates insulin titration and detection of hypoglycemia. Despite this, the uptake of SMBG remains low in many countries, including Malaysia.
Purpose
This study aimed to explore the barriers and facilitators to SMBG, in people with type 2 diabetes using insulin.
Patients and methods
Qualitative methodology was employed to explore participants’ experience with SMBG. Semistructured, individual in-depth interviews were conducted on people with type 2 diabetes using insulin who had practiced SMBG, in the primary care clinic of a teaching hospital in Malaysia. Participants were purposively sampled from different age groups, ethnicity, education level, and level of glycemic control (as reflected by the glycated hemoglobin [HbA1c]), to achieve maximum variation in sampling. All interviews were conducted using a topic guide and were audio-recorded, transcribed verbatim, checked, and analyzed using a thematic approach.
Results
A total of 15 participants were interviewed, and thematic saturation was reached. The factors that influenced SMBG were mainly related to cost, participants’ emotion, and the SMBG process. The barriers identified included: frustration related to high blood glucose reading; perception that SMBG was only for insulin titration; stigma; fear of needles and pain; cost of test strips and needles; inconvenience; unconducive workplace; and lack of motivation, knowledge, and self-efficacy. The facilitators were: experiencing hypoglycemic symptoms; desire to see the effects of dietary changes; desire to please the physician; and family motivation.
Conclusion
Participants’ perceptions of the purpose of SMBG, the emotions associated with SMBG, and the complexity, pain, and cost related to SMBG as well as personal and family motivation are the key factors that health care providers must consider when advising people with diabetes on SMBG.
doi:10.2147/PPA.S57567
PMCID: PMC3931581  PMID: 24627628
blood glucose self-monitoring; diabetes mellitus; in-depth interviews; qualitative study
8.  Getting Under the Skin of Clinical Inertia in Insulin Initiation: The Translating Research Into Action for Diabetes (TRIAD) Insulin Starts Project 
The Diabetes educator  2012;38(1):94-100.
Purpose
The purpose of this cross-sectional study is to explore primary care providers’ (PCPs) perceptions about barriers to initiating insulin among patients. Studies suggest that many patients with poorly controlled type 2 diabetes do not receive insulin initiation by PCPs.
Methods
As part of the TRIAD study, we conducted structured interviews in health systems in Indiana, New Jersey, and California, asking PCPs about the importance of insulin initiation and factors affecting this decision. We calculated proportions choosing each multiple-choice response option and listed the most frequently offered open-ended response categories.
Results
Among 83 PCPs, 45% were women, 60% were Caucasian, and they averaged 13.4 years in practice. Four-fifths of PCPs endorsed guideline-concordant glycemic targets, but 54% individualized targets based on patient age, life expectancy, medical co-morbidities, self-management capacity, and willingness. Most (64%) reported that many patients were resistant to new oral or insulin therapies due to fears about the therapy and what it meant about their disease progression. Two-thirds (64%) cited patient resistance as a barrier to insulin initiation, and 43% cited problems with patient self-management, including cognitive or mental health issues, dexterity, or ability to adhere.† Eighty percent felt that patient non-adherence would dissuade them from initiating insulin at least some of the time.
Conclusions
PCPs perceived that patient resistance and poor self-management skills were significant barriers to initiating insulin. Future studies should investigate whether systems-level interventions to improve patient-provider communication about insulin and enhance providers’ perceptions of patient self-management capacity can increase guideline-concordant, patient-centered insulin initiation.
doi:10.1177/0145721711432649
PMCID: PMC3557962  PMID: 22222513
diabetes; insulin therapy; clinical inertia; clinical decision-making
9.  GPs' approach to insulin prescribing in older patients: a qualitative study 
Background
Evidence suggests that insulin is under-prescribed in older people. Some reasons for this include physician's concerns about potential side-effects or patients' resistance to insulin. In general, however, little is known about how GPs make decisions related to insulin prescribing in older people.
Aim
To explore the process and rationale for prescribing decisions of GPs when treating older patients with type 2 diabetes.
Design of study
Qualitative individual interviews using a grounded theory approach.
Setting
Primary care.
Method
A thematic analysis was conducted to identify themes that reflected factors that influence the prescribing of insulin.
Results
Twenty-one GPs in active practice in Ontario completed interviews. Seven factors influencing the prescribing of insulin for older patients were identified: GPs' beliefs about older people; GPs' beliefs about diabetes and its management; gauging the intensity of therapy required; need for preparation for insulin therapy; presence of support from informal or formal healthcare provider; frustration with management complexity; and GPs' experience with insulin administration. Although GPs indicated that they would prescribe insulin allowing for the above factors, there was a mismatch in intended approach to prescribing and self-reported prescribing.
Conclusion
GPs' rationale for prescribing (or not prescribing) insulin is mediated by both practitioner-related and patient-related factors. GPs intended and actual prescribing varied depending on their assessment of each patient's situation. In order to improve prescribing for increasing numbers of older people with type 2 diabetes, more education for GPs, specialist support, and use of allied health professionals is needed.
doi:10.3399/bjgp08X319639
PMCID: PMC2566521  PMID: 18682013
insulin; primary health care; qualitative research; type 2 diabetes mellitus
10.  Barriers to Initiating Insulin in Type 2 Diabetes Patients: Development of a New Patient Education Tool to Address Myths, Misconceptions and Clinical Realities 
The Patient  2014;7(4):437-450.
Purpose
The purpose of this study was to identify patient beliefs as well as clinical realities about insulin that may be barriers to type 2 diabetes patients initiating insulin treatment when recommended by their physician. This information was then used to develop a clinically relevant, cross-culturally valid patient education tool with the goal of providing unbiased, medically informative statements addressing these barriers.
Methods
Thirteen focus groups were conducted in five countries (Germany, Sweden, The Netherlands, UK, and USA) to collect qualitative data on attitudes about insulin therapy from type 2 diabetes patients aged 18 or older whose physician had recommended initiating insulin treatment in the past 6 months (n = 87). Additionally, a panel of four clinical experts was interviewed to ascertain obstacles they experience in initiating insulin with their patients.
Results
On the basis of the interview data, the ten questions that asked about the most important barriers were generated. The clinical expert panel then generated clinically accurate and unbiased responses addressing these concerns, and the educational tool “Questions about Starting Insulin: Information on the Myths, Misconceptions and Clinical Realities about Insulin” was drafted. The draft tool was pilot tested in a group of patients and finalized.
Conclusions
Patient misconceptions, as well as some clinical realities, about insulin treatment and diabetes can influence the decision to initiate insulin treatment and ultimately impact disease management. The educational tool developed through this study was designed to help patients who are deciding whether or not to initiate insulin therapy as recommended by their physician, and facilitate patient–health-care provider interactions.
doi:10.1007/s40271-014-0068-x
PMCID: PMC4240906  PMID: 24958464
11.  Continuous Subcutaneous Insulin Infusion (CSII) Pumps for Type 1 and Type 2 Adult Diabetic Populations 
Executive Summary
In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry’s newly released Diabetes Strategy.
After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.
To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,
Diabetes Strategy Evidence Platform: Summary of Evidence-Based Analyses
Continuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based Analysis
Behavioural Interventions for Type 2 Diabetes: An Evidence-Based Analysis
Bariatric Surgery for People with Diabetes and Morbid Obesity: An Evidence-Based Summary
Community-Based Care for the Management of Type 2 Diabetes: An Evidence-Based Analysis
Home Telemonitoring for Type 2 Diabetes: An Evidence-Based Analysis
Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario
Objective
The objective of this analysis is to review the efficacy of continuous subcutaneous insulin infusion (CSII) pumps as compared to multiple daily injections (MDI) for the type 1 and type 2 adult diabetics.
Clinical Need and Target Population
Insulin therapy is an integral component of the treatment of many individuals with diabetes. Type 1, or juvenile-onset diabetes, is a life-long disorder that commonly manifests in children and adolescents, but onset can occur at any age. It represents about 10% of the total diabetes population and involves immune-mediated destruction of insulin producing cells in the pancreas. The loss of these cells results in a decrease in insulin production, which in turn necessitates exogenous insulin therapy.
Type 2, or ‘maturity-onset’ diabetes represents about 90% of the total diabetes population and is marked by a resistance to insulin or insufficient insulin secretion. The risk of developing type 2 diabetes increases with age, obesity, and lack of physical activity. The condition tends to develop gradually and may remain undiagnosed for many years. Approximately 30% of patients with type 2 diabetes eventually require insulin therapy.
CSII Pumps
In conventional therapy programs for diabetes, insulin is injected once or twice a day in some combination of short- and long-acting insulin preparations. Some patients require intensive therapy regimes known as multiple daily injection (MDI) programs, in which insulin is injected three or more times a day. It’s a time consuming process and usually requires an injection of slow acting basal insulin in the morning or evening and frequent doses of short-acting insulin prior to eating. The most common form of slower acting insulin used is neutral protamine gagedorn (NPH), which reaches peak activity 3 to 5 hours after injection. There are some concerns surrounding the use of NPH at night-time as, if injected immediately before bed, nocturnal hypoglycemia may occur. To combat nocturnal hypoglycemia and other issues related to absorption, alternative insulins have been developed, such as the slow-acting insulin glargine. Glargine has no peak action time and instead acts consistently over a twenty-four hour period, helping reduce the frequency of hypoglycemic episodes.
Alternatively, intensive therapy regimes can be administered by continuous insulin infusion (CSII) pumps. These devices attempt to closely mimic the behaviour of the pancreas, continuously providing a basal level insulin to the body with additional boluses at meal times. Modern CSII pumps are comprised of a small battery-driven pump that is designed to administer insulin subcutaneously through the abdominal wall via butterfly needle. The insulin dose is adjusted in response to measured capillary glucose values in a fashion similar to MDI and is thus often seen as a preferred method to multiple injection therapy. There are, however, still risks associated with the use of CSII pumps. Despite the increased use of CSII pumps, there is uncertainty around their effectiveness as compared to MDI for improving glycemic control.
Part A: Type 1 Diabetic Adults (≥19 years)
An evidence-based analysis on the efficacy of CSII pumps compared to MDI was carried out on both type 1 and type 2 adult diabetic populations.
Research Questions
Are CSII pumps more effective than MDI for improving glycemic control in adults (≥19 years) with type 1 diabetes?
Are CSII pumps more effective than MDI for improving additional outcomes related to diabetes such as quality of life (QoL)?
Literature Search
Inclusion Criteria
Randomized controlled trials, systematic reviews, meta-analysis and/or health technology assessments from MEDLINE, EMBASE, CINAHL
Adults (≥ 19 years)
Type 1 diabetes
Study evaluates CSII vs. MDI
Published between January 1, 2002 – March 24, 2009
Patient currently on intensive insulin therapy
Exclusion Criteria
Studies with <20 patients
Studies <5 weeks in duration
CSII applied only at night time and not 24 hours/day
Mixed group of diabetes patients (children, adults, type 1, type 2)
Pregnancy studies
Outcomes of Interest
The primary outcomes of interest were glycosylated hemoglobin (HbA1c) levels, mean daily blood glucose, glucose variability, and frequency of hypoglycaemic events. Other outcomes of interest were insulin requirements, adverse events, and quality of life.
Search Strategy
The literature search strategy employed keywords and subject headings to capture the concepts of:
1) insulin pumps, and
2) type 1 diabetes.
The search was run on July 6, 2008 in the following databases: Ovid MEDLINE (1996 to June Week 4 2008), OVID MEDLINE In-Process and Other Non-Indexed Citations, EMBASE (1980 to 2008 Week 26), OVID CINAHL (1982 to June Week 4 2008) the Cochrane Library, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment. A search update was run on March 24, 2009 and studies published prior to 2002 were also examined for inclusion into the review. Parallel search strategies were developed for the remaining databases. Search results were limited to human and English-language published between January 2002 and March 24, 2009. Abstracts were reviewed, and studies meeting the inclusion criteria outlined above were obtained. Reference lists were also checked for relevant studies.
Summary of Findings
The database search identified 519 relevant citations published between 1996 and March 24, 2009. Of the 519 abstracts reviewed, four RCTs and one abstract met the inclusion criteria outlined above. While efficacy outcomes were reported in each of the trials, a meta-analysis was not possible due to missing data around standard deviations of change values as well as missing data for the first period of the crossover arm of the trial. Meta-analysis was not possible on other outcomes (quality of life, insulin requirements, frequency of hypoglycemia) due to differences in reporting.
HbA1c
In studies where no baseline data was reported, the final values were used. Two studies (Hanaire-Broutin et al. 2000, Hoogma et al. 2005) reported a slight reduction in HbA1c of 0.35% and 0.22% respectively for CSII pumps in comparison to MDI. A slightly larger reduction in HbA1c of 0.84% was reported by DeVries et al.; however, this study was the only study to include patients with poor glycemic control marked by higher baseline HbA1c levels. One study (Bruttomesso et al. 2008) showed no difference between CSII pumps and MDI on Hba1c levels and was the only study using insulin glargine (consistent with results of parallel RCT in abstract by Bolli 2004). While there is statistically significant reduction in HbA1c in three of four trials, there is no evidence to suggest these results are clinically significant.
Mean Blood Glucose
Three of four studies reported a statistically significant reduction in the mean daily blood glucose for patients using CSII pump, though these results were not clinically significant. One study (DeVries et al. 2002) did not report study data on mean blood glucose but noted that the differences were not statistically significant. There is difficulty with interpreting study findings as blood glucose was measured differently across studies. Three of four studies used a glucose diary, while one study used a memory meter. In addition, frequency of self monitoring of blood glucose (SMBG) varied from four to nine times per day. Measurements used to determine differences in mean daily blood glucose between the CSII pump group and MDI group at clinic visits were collected at varying time points. Two studies use measurements from the last day prior to the final visit (Hoogma et al. 2005, DeVries et al. 2002), while one study used measurements taken during the last 30 days and another study used measurements taken during the 14 days prior to the final visit of each treatment period.
Glucose Variability
All four studies showed a statistically significant reduction in glucose variability for patients using CSII pumps compared to those using MDI, though one, Bruttomesso et al. 2008, only showed a significant reduction at the morning time point. Brutomesso et al. also used alternate measures of glucose variability and found that both the Lability index and mean amplitude of glycemic excursions (MAGE) were in concordance with the findings using the standard deviation (SD) values of mean blood glucose, but the average daily risk range (ADRR) showed no difference between the CSII pump and MDI groups.
Hypoglycemic Events
There is conflicting evidence concerning the efficacy of CSII pumps in decreasing both mild and severe hypoglycemic events. For mild hypoglycemic events, DeVries et al. observed a higher number of events per patient week in the CSII pump group than the MDI group, while Hoogma et al. observed a higher number of events per patient year in the MDI group. The remaining two studies found no differences between the two groups in the frequency of mild hypoglycemic events. For severe hypoglycemic events, Hoogma et al. found an increase in events per patient year among MDI patients, however, all of the other RCTs showed no difference between the patient groups in this aspect.
Insulin Requirements and Adverse Events
In all four studies, insulin requirements were significantly lower in patients receiving CSII pump treatment in comparison to MDI. This difference was statistically significant in all studies. Adverse events were reported in three studies. Devries et al. found no difference in ketoacidotic episodes between CSII pump and MDI users. Bruttomesso et al. reported no adverse events during the study. Hanaire-Broutin et al. found that 30 patients experienced 58 serious adverse events (SAEs) during MDI and 23 patients had 33 SAEs during treatment out of a total of 256 patients. Most events were related to severe hypoglycemia and diabetic ketoacidosis.
Quality of Life and Patient Preference
QoL was measured in three studies and patient preference was measured in one. All three studies found an improvement in QoL for CSII users compared to those using MDI, although various instruments were used among the studies and possible reporting bias was evident as non-positive outcomes were not consistently reported. Moreover, there was also conflicting results in two of the studies using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). DeVries et al. reported no difference in treatment satisfaction between CSII pump users and MDI users while Brutomesso et al. reported that treatment satisfaction improved among CSII pump users.
Patient preference for CSII pumps was demonstrated in just one study (Hanaire-Broutin et al. 2000) and there are considerable limitations with interpreting this data as it was gathered through interview and 72% of patients that preferred CSII pumps were previously on CSII pump therapy prior to the study. As all studies were industry sponsored, findings on QoL and patient preference must be interpreted with caution.
Quality of Evidence
Overall, the body of evidence was downgraded from high to low due to study quality and issues with directness as identified using the GRADE quality assessment tool (see Table 1) While blinding of patient to intervention/control was not feasible in these studies, blinding of study personnel during outcome assessment and allocation concealment were generally lacking. Trials reported consistent results for the outcomes HbA1c, mean blood glucose and glucose variability, but the directness or generalizability of studies, particularly with respect to the generalizability of the diabetic population, was questionable as most trials used highly motivated populations with fairly good glycemic control. In addition, the populations in each of the studies varied with respect to prior treatment regimens, which may not be generalizable to the population eligible for pumps in Ontario. For the outcome of hypoglycaemic events the evidence was further downgraded to very low since there was conflicting evidence between studies with respect to the frequency of mild and severe hypoglycaemic events in patients using CSII pumps as compared to CSII (see Table 2). The GRADE quality of evidence for the use of CSII in adults with type 1 diabetes is therefore low to very low and any estimate of effect is, therefore, uncertain.
GRADE Quality Assessment for CSII pumps vs. MDI on HbA1c, Mean Blood Glucose, and Glucose Variability for Adults with Type 1 Diabetes
Inadequate or unknown allocation concealment (3/4 studies); Unblinded assessment (all studies) however lack of blinding due to the nature of the study; No ITT analysis (2/4 studies); possible bias SMBG (all studies)
HbA1c: 3/4 studies show consistency however magnitude of effect varies greatly; Single study uses insulin glargine instead of NPH; Mean Blood Glucose: 3/4 studies show consistency however magnitude of effect varies between studies; Glucose Variability: All studies show consistency but 1 study only showed a significant effect in the morning
Generalizability in question due to varying populations: highly motivated populations, educational component of interventions/ run-in phases, insulin pen use in 2/4 studies and varying levels of baseline glycemic control and experience with intensified insulin therapy, pumps and MDI.
GRADE Quality Assessment for CSII pumps vs. MDI on Frequency of Hypoglycemic
Inadequate or unknown allocation concealment (3/4 studies); Unblinded assessment (all studies) however lack of blinding due to the nature of the study; No ITT analysis (2/4 studies); possible bias SMBG (all studies)
Conflicting evidence with respect to mild and severe hypoglycemic events reported in studies
Generalizability in question due to varying populations: highly motivated populations, educational component of interventions/ run-in phases, insulin pen use in 2/4 studies and varying levels of baseline glycemic control and experience with intensified insulin therapy, pumps and MDI.
Economic Analysis
One article was included in the analysis from the economic literature scan. Four other economic evaluations were identified but did not meet our inclusion criteria. Two of these articles did not compare CSII with MDI and the other two articles used summary estimates from a mixed population with Type 1 and 2 diabetes in their economic microsimulation to estimate costs and effects over time. Included were English articles that conducted comparisons between CSII and MDI with the outcome of Quality Adjusted Life Years (QALY) in an adult population with type 1 diabetes.
From one study, a subset of the population with type 1 diabetes was identified that may be suitable and benefit from using insulin pumps. There is, however, limited data in the literature addressing the cost-effectiveness of insulin pumps versus MDI in type 1 diabetes. Longer term models are required to estimate the long term costs and effects of pumps compared to MDI in this population.
Conclusions
CSII pumps for the treatment of adults with type 1 diabetes
Based on low-quality evidence, CSII pumps confer a statistically significant but not clinically significant reduction in HbA1c and mean daily blood glucose as compared to MDI in adults with type 1 diabetes (>19 years).
CSII pumps also confer a statistically significant reduction in glucose variability as compared to MDI in adults with type 1 diabetes (>19 years) however the clinical significance is unknown.
There is indirect evidence that the use of newer long-acting insulins (e.g. insulin glargine) in MDI regimens result in less of a difference between MDI and CSII compared to differences between MDI and CSII in which older insulins are used.
There is conflicting evidence regarding both mild and severe hypoglycemic events in this population when using CSII pumps as compared to MDI. These findings are based on very low-quality evidence.
There is an improved quality of life for patients using CSII pumps as compared to MDI however, limitations exist with this evidence.
Significant limitations of the literature exist specifically:
All studies sponsored by insulin pump manufacturers
All studies used crossover design
Prior treatment regimens varied
Types of insulins used in study varied (NPH vs. glargine)
Generalizability of studies in question as populations were highly motivated and half of studies used insulin pens as the mode of delivery for MDI
One short-term study concluded that pumps are cost-effective, although this was based on limited data and longer term models are required to estimate the long-term costs and effects of pumps compared to MDI in adults with type 1 diabetes.
Part B: Type 2 Diabetic Adults
Research Questions
Are CSII pumps more effective than MDI for improving glycemic control in adults (≥19 years) with type 2 diabetes?
Are CSII pumps more effective than MDI for improving other outcomes related to diabetes such as quality of life?
Literature Search
Inclusion Criteria
Randomized controlled trials, systematic reviews, meta-analysis and/or health technology assessments from MEDLINE, Excerpta Medica Database (EMBASE), Cumulative Index to Nursing & Allied Health Literature (CINAHL)
Any person with type 2 diabetes requiring insulin treatment intensive
Published between January 1, 2000 – August 2008
Exclusion Criteria
Studies with <10 patients
Studies <5 weeks in duration
CSII applied only at night time and not 24 hours/day
Mixed group of diabetes patients (children, adults, type 1, type 2)
Pregnancy studies
Outcomes of Interest
The primary outcome of interest was a reduction in glycosylated hemoglobin (HbA1c) levels. Other outcomes of interest were mean blood glucose level, glucose variability, insulin requirements, frequency of hypoglycemic events, adverse events, and quality of life.
Search Strategy
A comprehensive literature search was performed in OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, The Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published between January 1, 2000 and August 15, 2008. Studies meeting the inclusion criteria were selected from the search results. Data on the study characteristics, patient characteristics, primary and secondary treatment outcomes, and adverse events were abstracted. Reference lists of selected articles were also checked for relevant studies. The quality of the evidence was assessed as high, moderate, low, or very low according to the GRADE methodology.
Summary of Findings
The database search identified 286 relevant citations published between 1996 and August 2008. Of the 286 abstracts reviewed, four RCTs met the inclusion criteria outlined above. Upon examination, two studies were subsequently excluded from the meta-analysis due to small sample size and missing data (Berthe et al.), as well as outlier status and high drop out rate (Wainstein et al) which is consistent with previously reported meta-analyses on this topic (Jeitler et al 2008, and Fatourechi M et al. 2009).
HbA1c
The primary outcome in this analysis was reduction in HbA1c. Both studies demonstrated that both CSII pumps and MDI reduce HbA1c, but neither treatment modality was found to be superior to the other. The results of a random effects model meta-analysis showed a mean difference in HbA1c of -0.14 (-0.40, 0.13) between the two groups, which was found not to be statistically or clinically significant. There was no statistical heterogeneity observed between the two studies (I2=0%).
Forrest plot of two parallel, RCTs comparing CSII to MDI in type 2 diabetes
Secondary Outcomes
Mean Blood Glucose and Glucose Variability
Mean blood glucose was only used as an efficacy outcome in one study (Raskin et al. 2003). The authors found that the only time point in which there were consistently lower blood glucose values for the CSII group compared to the MDI group was 90 minutes after breakfast. Glucose variability was not examined in either study and the authors reported no difference in weight gain between the CSII pump group and MDI groups at the end of study. Conflicting results were reported regarding injection site reactions between the two studies. Herman et al. reported no difference in the number of subjects experiencing site problems between the two groups, while Raskin et al. reported that there were no injection site reactions in the MDI group but 15 such episodes among 8 participants in the CSII pump group.
Frequency of Hypoglycemic Events and Insulin Requirements
All studies reported that there were no differences in the number of mild hypoglycemic events in patients on CSII pumps versus MDI. Herman et al. also reported no differences in the number of severe hypoglycemic events in patients using CSII pumps compared to those on MDI. Raskin et al. reported that there were no severe hypoglycemic events in either group throughout the study duration. Insulin requirements were only examined in Herman et al., who found that daily insulin requirements were equal between the CSII pump and MDI treatment groups.
Quality of Life
QoL was measured by Herman et al. using the Diabetes Quality of Life Clinical Trial Questionnaire (DQOLCTQ). There were no differences reported between CSII users and MDI users for treatment satisfaction, diabetes impact, and worry-related scores. Patient satisfaction was measured in Raskin et al. using a patient satisfaction questionnaire, whose results indicated that patients in the CSII pump group had significantly greater improvement in overall treatment satisfaction at the end of the study compared to the MDI group. Although patient preference was also reported, it was only examined in the CSII pump group, thus results indicating a greater preference for CSII pumps in this groups (as compared to prior injectable insulin regimens) are biased and must be interpreted with caution.
Quality of Evidence
Overall, the body of evidence was downgraded from high to low according to study quality and issues with directness as identified using the GRADE quality assessment tool (see Table 3). While blinding of patient to intervention/control is not feasible in these studies, blinding of study personnel during outcome assessment and allocation concealment were generally lacking. ITT was not clearly explained in one study and heterogeneity between study populations was evident from participants’ treatment regimens prior to study initiation. Although trials reported consistent results for HbA1c outcomes, the directness or generalizability of studies, particularly with respect to the generalizability of the diabetic population, was questionable as trials required patients to adhere to an intense SMBG regimen. This suggests that patients were highly motivated. In addition, since prior treatment regimens varied between participants (no requirement for patients to be on MDI), study findings may not be generalizable to the population eligible for a pump in Ontario. The GRADE quality of evidence for the use of CSII in adults with type 2 diabetes is, therefore, low and any estimate of effect is uncertain.
GRADE Quality Assessment for CSII pumps vs. MDI on HbA1c Adults with Type 2 Diabetes
Inadequate or unknown allocation concealment (all studies); Unblinded assessment (all studies) however lack of blinding due to the nature of the study; ITT not well explained in 1 of 2 studies
Indirect due to lack of generalizability of findings since participants varied with respect to prior treatment regimens and intensive SMBG suggests highly motivated populations used in trials.
Economic Analysis
An economic analysis of CSII pumps was carried out using the Ontario Diabetes Economic Model (ODEM) and has been previously described in the report entitled “Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario”, part of the diabetes strategy evidence series. Based on the analysis, CSII pumps are not cost-effective for adults with type 2 diabetes, either for the age 65+ sub-group or for all patients in general. Details of the analysis can be found in the full report.
Conclusions
CSII pumps for the treatment of adults with type 2 diabetes
There is low quality evidence demonstrating that the efficacy of CSII pumps is not superior to MDI for adult type 2 diabetics.
There were no differences in the number of mild and severe hypoglycemic events in patients on CSII pumps versus MDI.
There are conflicting findings with respect to an improved quality of life for patients using CSII pumps as compared to MDI.
Significant limitations of the literature exist specifically:
All studies sponsored by insulin pump manufacturers
Prior treatment regimens varied
Types of insulins used in study varied (NPH vs. glargine)
Generalizability of studies in question as populations may not reflect eligible patient population in Ontario (participants not necessarily on MDI prior to study initiation, pen used in one study and frequency of SMBG required during study was high suggesting highly motivated participants)
Based on ODEM, insulin pumps are not cost-effective for adults with type 2 diabetes either for the age 65+ sub-group or for all patients in general.
PMCID: PMC3377523  PMID: 23074525
12.  Primary care physician beliefs about insulin initiation in patients with type 2 diabetes 
Background
Insulin is the most effective drug available to achieve glycaemic goals in patients with type 2 diabetes. Yet, there is reluctance among physicians, specifically primary care physicians (PCPs) in the USA, to initiate insulin therapy in these patients.
Aims
To describe PCPs’ attitudes about the initiation of insulin in patients with type 2 diabetes and identify areas in which there is a clear lack of consensus.
Methods
Primary care physicians practicing in the USA, seeing 10 or more patients with type 2 diabetes per week, and having > 3 years of clinical practice were surveyed via an internet site. The survey was developed through literature review, qualitative study and expert panel.
Results
Primary care physicians (n = 505, mean age = 46 years, 81% male, 62% with > 10 years practice; 52% internal medicine) showed greatest consensus on attitudes regarding risk/benefits of insulin therapy, positive experiences of patients on insulin and patient fears or concerns about initiating insulin. Clear lack of consensus was seen in attitudes about the metabolic effects of insulin, need for insulin therapy, adequacy of self-monitoring blood glucose, time needed for training and potential for hypoglycaemia in elderly patients.
Conclusions
The beliefs of some PCPs are inconsistent with their diabetes treatment goals (HbA1c ≤ 7%). Continuing medical education programmes that focus on increasing primary care physician knowledge about the progression of diabetes, the physiological effects of insulin, and tools for successfully initiating insulin in patients with type 2 diabetes are needed.
Disclosures
Drs Hayes and Jacober are employees and stockholders of Eli Lilly and Company. Dr Fitzgerald is a consultant to Eli Lilly and Company.
What's knownInsulin is the most effective drug available to achieve glycaemic goals in patients with type 2 diabetes, yet there is reluctance among many physicians to initiate insulin therapy in these patients. Diabetes specialists tend to be more aggressive than primary care physicians (PCPs) with insulin initiation in patients with type 2 diabetes, and US physicians are more disposed to delay insulin than physicians in other countries.What's newThis article confirms that US PCPs lack consensus on some beliefs about insulin initiation. Consensus was seen regarding insulin risk/benefits, positive patient experiences of insulin and patient fears about initiating insulin. No consensus was seen regarding insulin's metabolic effects, need for insulin, adequacy of self-monitoring blood glucose, time needed for training and potential for hypoglycaemia in elderly patients. Some PCPs have beliefs inconsistent with their diabetes treatment goals (HbA1c ≤ 7%).
doi:10.1111/j.1742-1241.2008.01742.x
PMCID: PMC2408662  PMID: 18393965
13.  Prevention of type 2 diabetes in British Bangladeshis: qualitative study of community, religious, and professional perspectives 
Objective To understand lay beliefs and attitudes, religious teachings, and professional perceptions in relation to diabetes prevention in the Bangladeshi community.
Design Qualitative study (focus groups and semistructured interviews).
Setting Tower Hamlets, a socioeconomically deprived London borough, United Kingdom.
Participants Bangladeshi people without diabetes (phase 1), religious leaders and Islamic scholars (phase 2), and health professionals (phase 3).
Methods 17 focus groups were run using purposive sampling in three sequential phases. Thematic analysis was used iteratively to achieve progressive focusing and to develop theory. To explore tensions in preliminary data fictional vignettes were created, which were discussed by participants in subsequent phases. The PEN-3 multilevel theoretical framework was used to inform data analysis and synthesis.
Results Most lay participants accepted the concept of diabetes prevention and were more knowledgeable than expected. Practical and structural barriers to a healthy lifestyle were commonly reported. There was a strong desire to comply with cultural norms, particularly those relating to modesty. Religious leaders provided considerable support from Islamic teachings for messages about diabetes prevention. Some clinicians incorrectly perceived Bangladeshis to be poorly informed and fatalistic, although they also expressed concerns about their own limited cultural understanding.
Conclusion Contrary to the views of health professionals and earlier research, poor knowledge was not the main barrier to healthy lifestyle choices. The norms and expectations of Islam offer many opportunities for supporting diabetes prevention. Interventions designed for the white population, however, need adaptation before they will be meaningful to many Bangladeshis. Religion may have an important part to play in supporting health promotion in this community. The potential for collaborative working between health educators and religious leaders should be explored further and the low cultural understanding of health professionals addressed.
doi:10.1136/bmj.a1931
PMCID: PMC2659954  PMID: 18984633
14.  Home Telemonitoring for Type 2 Diabetes 
Executive Summary
In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry’s newly released Diabetes Strategy.
After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.
To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,
Diabetes Strategy Evidence Platform: Summary of Evidence-Based Analyses
Continuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based Analysis
Behavioural Interventions for Type 2 Diabetes: An Evidence-Based Analysis
Bariatric Surgery for People with Diabetes and Morbid Obesity: An Evidence-Based Summary
Community-Based Care for the Management of Type 2 Diabetes: An Evidence-Based Analysis
Home Telemonitoring for Type 2 Diabetes: An Evidence-Based Analysis
Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario
Objective
The objective of this report is to determine whether home telemonitoring and management of blood glucose is effective for improving glycemic control in adults with type 2 diabetes.
Background
An aging population coupled with a shortage of nurses and physicians in Ontario is increasing the demand for home care services for chronic diseases, including diabetes. In recent years, there has also been a concurrent rise in the number of blood glucose home telemonitoring technologies available for diabetes management. The Canadian Diabetes Association (CDA) currently recommends self-monitoring of blood glucose for patients with type 2 diabetes, particularly for individuals using insulin. With the emergence of home telemonitoring, there is potential for improving the impact of self-monitoring by linking patients with health care professionals who can monitor blood glucose values and then provide guided recommendations remotely. The MAS has, therefore, conducted a review of the available evidence on blood glucose home telemonitoring and management technologies for type 2 diabetes.
Evidence-Based Analysis of Effectiveness
Research Question
Is home telemonitoring of blood glucose for adults with type 2 diabetes more efficacious in improving glycemic control (i.e. can it reduce HbA1c levels) in comparison to usual care?
Literature Search
Inclusion Criteria
Intervention: Must involve the frequent transmission of remotely-collected blood glucose measurements by patients to health care professionals for routine monitoring through the use of home telemonitoring technology.
Intervention: Monitoring must be combined with a coordinated management and feedback system based on transmitted data.
Control: Usual diabetes care as provided by the usual care provider (usual care largely varies by jurisdiction and study).
Population: Adults ≥18 years of age with type 2 diabetes.
Follow-up: ≥6 months.
Sample size: ≥30 patients total.
Publication type: Randomized controlled trials (RCTs), systematic reviews, and/or meta-analyses.
Publication date range: January 1, 1998 to January 31, 2009.
Exclusion Criteria
Studies with a control group other than usual care.
Studies published in a language other than English.
Studies in which there is indication that the monitoring of patients’ diabetic measurements by a health care professional(s) was not occurring more frequently in intervention patients than in control patients receiving usual care.
Outcomes of Interest
The primary outcome of interest was a reduction in glycosylated hemoglobin (HbA1c) levels.
Search Strategy
A comprehensive literature search was performed in OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, The Cochrane Library, and INAHTA for studies published between January 1, 2007 and January 31, 2009. The search was designed as a continuation of a search undertaken for a systematic review by the Canadian Agency for Drugs and Technologies in Health, originally encompassing studies published from 1950 up until July of 2008 and which reviewed home telemonitoring in comparison to usual care for the management of type 1 and type 2 diabetes.
Summary of Findings
A total of eight studies identified by the literature search were eligible for inclusion (one was excluded post-hoc from analysis). Studies varied considerably on characteristics of design, population, and intervention/control. Of note, few trials limited populations to type 2 diabetics only, thus trials with mixed populations (type 1 and type 2) were included, though in such cases, the majority of patients (>60%) had type 2 diabetes. No studies restricted inclusion or analyses by diabetes treatment type (i.e. populations were mixed with respect to those on insulin therapy vs. not) and studies further varied on whether intervention was provided in addition to usual care or as a replacement. Lastly, trials often included blood glucose home telemonitoring as an adjunct to other telemedicine components and thus the incremental value of adding home telemonitoring remains unclear. The overall grading of the quality of evidence was low, indicating that there is uncertainty in the findings.
Meta-analysis of the seven trials identified a moderate but significant reduction in HbA1c levels (~0.5% reduction) in favour blood glucose home telemonitoring compared to usual care for adults with type 2 diabetes). Subgroup analyses suggested differences in effect size depending on the type of intervention, however, these findings should be held under caution as the analyses were exploratory in nature and intervention components overlapped between subgroups.
Meta-Analyses of Reduction in HbA1c Values for Analyzed Studies
Conclusions
Based on low quality evidence, blood glucose home telemonitoring technologies confer a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes.
Exploratory analysis suggests differences in effect sizes for the primary outcome when analyzing by subgroup; however, this should only be viewed as exploratory or hypothesis-generating only.
Significant limitations and/or sources of clinical heterogeneity are present in the available literature, generating great uncertainty in conclusions.
More robust trials in type 2 diabetics only, utilizing more modern technologies, preferably performed in an Ontario or a similar setting (given the infrastructure demands and that the standard comparator is usual care), while separating out the effects of other telemedicine intervention components, are needed to clarify the effect of emerging remote blood glucose monitoring technologies.
PMCID: PMC3377533  PMID: 23074529
15.  Diabetes Patients' Experiences With the Implementation of Insulin Therapy and Their Perceptions of Computer-Assisted Self-Management Systems for Insulin Therapy 
Background
Computer-assisted decision support is an emerging modality to assist patients with type 2 diabetes mellitus (T2DM) in insulin self-titration (ie, self-adjusting insulin dose according to daily blood glucose levels). Computer-assisted insulin self-titration systems mainly focus on helping patients overcome barriers related to the cognitive components of insulin titration. Yet other (eg, psychological or physical) barriers could still impede effective use of such systems.
Objective
Our primary aim was to identify experiences with and barriers to self-monitoring of blood glucose, insulin injection, and insulin titration among patients with T2DM. Our research team developed a computer-assisted insulin self-titration system, called PANDIT. The secondary aim of this study was to evaluate patients’ perceptions of computer-assisted insulin self-titration. We included patients who used PANDIT in a 4-week pilot study as well as patients who had never used such a system.
Methods
In-depth, semi-structured interviews were conducted individually with patients on insulin therapy who were randomly recruited from a university hospital and surrounding general practices in the Netherlands. The interviews were transcribed verbatim and analyzed qualitatively. To classify the textual remarks, we created a codebook during the analysis, in a bottom-up and iterative fashion. To support examination of the final coded data, we used three theories from the field of health psychology and the integrated model of user satisfaction and technology acceptance by Wixom and Todd.
Results
When starting insulin therapy, some patients feared a lifelong commitment to insulin therapy and disease progression. Also, many barriers arose when implementing insulin therapy (eg, some patients were embarrassed to inject insulin in public). Furthermore, patients had difficulties increasing the insulin dose because they fear hypoglycemia, they associate higher insulin doses with disease progression, and some were ignorant of treatment targets. Patients who never used a computer-assisted insulin self-titration system felt they had enough knowledge to know when their insulin should be adjusted, but still believed that the system advice would be useful to confirm their reasoning. Furthermore, the time and effort saved with automated insulin advice was considered an advantage. Patients who had used PANDIT found the system useful if their glycemic regulation improved. Nevertheless, for some patients, the absence of personal contact with their caregiver was a drawback. While guidelines state that adjustment of basal insulin dose based on fasting plasma glucose values is sufficient, both patients who had and those who had not used PANDIT felt that such a system should take more patient data into consideration, such as lifestyle and diet factors.
Conclusions
Patients encounter multiple obstacles when implementing insulin therapy. Computer-assisted insulin self-titration can increase patient awareness of treatment targets and increase their confidence in self-adjusting the insulin dose. Nevertheless, some barriers may still exist when using computer-assisted titration systems and these systems could also introduce new barriers.
doi:10.2196/jmir.3198
PMCID: PMC4259961  PMID: 25340869
Type 2 diabetes mellitus; clinical decision support systems; patient acceptance of health care
16.  Arabic-speaking migrants’ attitudes, opinions, preferences and past experiences concerning the use of interpreters in healthcare: a postal cross-sectional survey 
BMC Research Notes  2014;7:71.
Background
Good communication is an important prerequisite for equal treatment in a healthcare encounter. One way to overcome language barriers when patients and healthcare staff do not share the same language is to use a professional interpreter. Few previous studies have been found investigating the use of interpreters, and just one previous study from the perspective of European migrants, which showed that they perceived interpreters as a communication aid and a guide in the healthcare system as regards information and practical matters. No previous study has gathered quantitative information to focus on non-European migrants’ attitudes to the use of interpreters in healthcare encounters. Thus, the aim of this study was to investigate Arabic-speaking individuals’ attitudes, opinions, preferences and past experiences concerning the use of interpreters in healthcare in order to: (i) understand how persons’ expectations and concerns regarding interpreters may vary, both within and across cultural/linguistic populations; (ii) understand the consequences of diverse opinions/expectations for planning responsive services; and (iii) confirm findings from previous qualitative studies.
Method
A postal cross-sectional study using a structured self-administered 51-item questionnaire was used to describe and document aspects of Arabic-speaking individuals’ attitudes to the use of interpreters in healthcare. The sample of 53 Arabic-speaking migrants was recruited from three different places. Participants were mostly born in Iraq and had a high level of education and were almost equally divided between genders. Data were analysed with descriptive statistics.
Results
The main findings were that most of the participants perceived the interpreter’s role as being a communication aid and a practical aid, interpreting literally and objectively. Trust in the professional interpreter was related to qualification as an interpreter and personal contact with face-to-face interaction. The qualities of the desired professional interpreter were: a good knowledge of languages and medical terminology, translation ability, and sharing the same origin, dialect and gender as the patient.
Conclusion
This study confirmed previous qualitative findings from European migrant groups with a different cultural and linguistic background. The study supports the importance of planning a good interpretation situation in accordance with individuals’ desire, irrespective of the migrant’s linguistic and cultural background, and using interpreters who interpret literally and objectively, who are highly trained with language skills in medical terminology, and with a professional attitude to promote communication, thus increasing cost-effective, high-quality individualized healthcare.
doi:10.1186/1756-0500-7-71
PMCID: PMC3915075  PMID: 24484628
Arabic-speaking migrants; Communication; Cross-sectional survey; Healthcare encounter; Structured self-administered questionnaire; Use of interpreters
17.  Cost of severe hypoglycaemia in patients with type 1 diabetes in Spain and the cost-effectiveness of insulin lispro compared with regular human insulin in preventing severe hypoglycaemia 
Objectives
To determine the costs of severe hypoglycaemia (SH) in a population of patients with type 1 diabetes mellitus in the Spanish healthcare system and the cost-effectiveness of insulin lispro over regular insulin in preventing SH episodes.
Methods
A retrospective study of 100 patients in three Spanish health centres was performed. Resource utilisation data were collected only for interventions specifically relating to the hypoglycaemic episode. The direct medical costs determined in the analyses were: costs of hospitalisation, diagnostic tests carried out, costs of treatment administered and other associated costs such as visits to the endocrinologist and re-training in glucose control, transportation and assistance of a care-giver. In addition, indirect costs such as days of lost productivity were measured. The incidence rates of SH for insulin lispro and regular insulin were obtained from the literature. The incremental cost-effectiveness of insulin lispro over regular insulin was calculated.
Results
The overall mean cost per episode of SH was €366, comprised of 65.4% direct costs and 35.6% indirect costs. The largest cost was for hospitalisation at €183 per episode. The SH episodes incidence rates for 100 patients per year were 33 and 73 for insulin lispro and 48 (p < 0.05) and 117 (p < 0.01) for regular insulin, in the two clinical trials found in the literature. The additional cost to prevent one episode of SH with insulin lispro over regular insulin ranged from €277 to insulin lispro dominance.
Conclusions
Severe hypoglycaemia has a significant impact on the total cost of diabetes. The use of insulin lispro is associated with reductions in annual costs because of SH and, possibly, the overall effect may be cost neutral or cost saving when total costs are considered. The cost of SH should be included in the analysis of total socio-economic burden of diabetes.
Disclosures J. Reviriego and J. Sacristan are currently employees of Lilly Spain. Dr Gomis, Dr Marañes and Dr Ricart have served as consultant and speakers in Lilly medical educational and scientific meetings. In addition all authors at some point have been involved as investigators in Lilly registration trials.
What's knownLittle or none data were available with respect to the costs of acute diabetes-related complications associated with insulin treatment as is the case for severe hypoglycaemia.What's newWe provide valuable information on the impact of therapeutic alternatives such as the use of an insulin analogue (insulin lispro) vs. regular human insulin on the total cost of diabetes.
doi:10.1111/j.1742-1241.2008.01783.x
PMCID: PMC2438603  PMID: 18489577
18.  Why do some people with type 2 diabetes who are using insulin have poor glycaemic control? A qualitative study 
BMJ Open  2015;5(1):e006407.
Objective
To explore factors influencing poor glycaemic control in people with type 2 diabetes using insulin.
Research design
A qualitative method comprising in-depth individual interviews. A semistructured interview guide was used. The interviews were audiorecorded, transcribed verbatim and analysed using a thematic approach.
Participants
Seventeen people with type 2 diabetes using insulin with glycated haemoglobin (HbA1c) ≥9% for >1 year.
Setting
The Primary Care Clinic and Diabetes Clinic in the University of Malaya Medical Centre (UMMC), Malaysia.
Results
Data analysis uncovered four themes: lifestyle challenges in adhering to medical recommendations; psychosocial and emotional hurdles; treatment-related factors; lack of knowledge about and self-efficacy in diabetes self-care.
Conclusions
Factors that explain the poor glycaemic control in people with type 2 diabetes using insulin were identified. Healthcare providers could use these findings to address patients’ concerns during consultations and help to improve glycaemic control.
doi:10.1136/bmjopen-2014-006407
PMCID: PMC4316456  PMID: 25633285
PRIMARY CARE; SOCIAL MEDICINE; PUBLIC HEALTH; PREVENTIVE MEDICINE
19.  Baseline characteristics of the IMPROVE control study population: A study to evaluate the effectiveness of a standardized healthcare professionals training program 
Introduction:
The IMPROVE Control Training program was designed by Indian Academy of Diabetes (IAD), and a non-intervention study was conducted to evaluate the effectiveness of this standardized healthcare professionals (HCPs) training program on achieving treatment goals in patients with diabetes mellitus and its impact on standard of care.
Materials and Methods:
This multi-center, parallel group, open-label, non-randomized, non-intervention study included patients with type 2 diabetes who had an HbA1c >9 at time of diagnosis or an HbA1c >7% even after 6 months of initiation of therapy with anti-diabetic agents (Oral anti diabetic agents (OADs) and/or insulin). The data recorded at baseline included demographic characteristics, medical history, and the treatment regimens.
Results:
The study included 20,493 patients with diabetes, of which 13,295 (64.9%) were men. The mean [standard deviation (SD)] duration of diabetes was 6.4 (4.2) years and 6608 (32.2%) reported complications of diabetes. Poor glycemic control [HbA1c = 9.4 (1.3), FPG (mg/dl) = 181.2 (45.7); mean (SD)] was observed. The postprandial glucose was also high [post-breakfast, lunch, and dinner values in mg/dl were 263.6 (68.5), 278.1 (69.6), and 250.2 (63.7), respectively] in these patients. Failure of OADs was the most common reason cited for initiation of insulin. Premixed insulin was rated the regimen of choice for initiating therapy by the physicians (62.2% vs. 34.5% who preferred basal insulin).
Conclusion:
The baseline results confirm the poor glycemic control and the delayed initiation and/or inadequacy of treatment in subjects with type 2 diabetes. These results also highlight the need for early and optimal insulin-based therapy.
doi:10.4103/2230-8210.104135
PMCID: PMC3603118  PMID: 23565470
baseline characteristics; oral anti diabetic agents failure; insulin initiation; IMPROVE
20.  Fast tracking the design of theory-based KT interventions through a consensus process 
Background
Despite available evidence for optimal management of spinal pain, poor adherence to guidelines and wide variations in healthcare services persist. One of the objectives of the Canadian Chiropractic Guideline Initiative is to develop and evaluate targeted theory- and evidence-informed interventions to improve the management of non-specific neck pain by chiropractors. In order to systematically develop a knowledge translation (KT) intervention underpinned by the Theoretical Domains Framework (TDF), we explored the factors perceived to influence the use of multimodal care to manage non-specific neck pain, and mapped behaviour change techniques to key theoretical domains.
Methods
Individual telephone interviews exploring beliefs about managing neck pain were conducted with a purposive sample of 13 chiropractors. The interview guide was based upon the TDF. Interviews were digitally recorded, transcribed verbatim and analysed by two independent assessors using thematic content analysis. A 15-member expert panel formally met to design a KT intervention.
Results
Nine TDF domains were identified as likely relevant. Key beliefs (and relevant domains of the TDF) included the following: influence of formal training, colleagues and patients on clinicians (Social Influences); availability of educational material (Environmental Context and Resources); and better clinical outcomes reinforcing the use of multimodal care (Reinforcement). Facilitating factors considered important included better communication (Skills); audits of patients’ treatment-related outcomes (Behavioural Regulation); awareness and agreement with guidelines (Knowledge); and tailoring of multimodal care (Memory, Attention and Decision Processes). Clinicians conveyed conflicting beliefs about perceived threats to professional autonomy (Social/Professional Role and Identity) and speed of recovery from either applying or ignoring the practice recommendations (Beliefs about Consequences). The expert panel mapped behaviour change techniques to key theoretical domains and identified relevant KT strategies and modes of delivery to increase the use of multimodal care among chiropractors.
Conclusions
A multifaceted KT educational intervention targeting chiropractors’ management of neck pain was developed. The KT intervention consisted of an online education webinar series, clinical vignettes and a video underpinned by the Brief Action Planning model. The intervention was designed to reflect key theoretical domains, behaviour change techniques and intervention components. The effectiveness of the proposed intervention remains to be tested.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0213-5) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-015-0213-5
PMCID: PMC4330935
Theoretical domains framework; Knowledge translation; Interviews; Content analysis; Intervention design; Multifaceted intervention; Chiropractic; Neck pain; Self-management
21.  Differences in the perceived role of the healthcare provider in delivering vascular health checks: a Q methodology study 
BMC Family Practice  2013;14:172.
Background
The UK Department of Health introduced the National Health Service (NHS) Health Check Programme in April 2009 in an attempt to improve primary and secondary prevention of cardiovascular disease in the UK population and to reduce health inequalities. Healthcare professionals' attitudes towards giving lifestyle advice will influence how they interact with patients during consultations. We therefore sought to identify the attitudes of primary care healthcare professionals towards the delivery of lifestyle advice in the context of the NHS Health Check Programme.
Methods
Fifty-two primary care healthcare professionals undertook a Q sort with 36 statements that represented a range of viewpoints about the importance of lifestyle change, medication, giving lifestyle advice in the primary care setting, and the individual, social and material factors that might impact on lifestyle related behaviour change. Sorts were analysed by-person using principal components analysis and varimax rotation.
Results
Five statistically independent factors (accounts) reflected distinct views on the topic. Account 1 was supportive of initiatives like the NHS Health Check, and emphasised the importance of professionals working collaboratively with patients to facilitate lifestyle change. Account 2 expressed views on the potential overuse of statin medication and placed responsibility for lifestyle change with the patient. Account 3 viewed the healthcare professional role to be one of educator, emphasising the provision of information. Account 4 perceived lifestyle change to be difficult for patients and emphasised the need for healthcare professionals to be role models. Account 5 was inconsistent about the value of lifestyle change, or the role of healthcare professionals in promoting it, a finding that may be due to ambivalence about the health check or to lack of engagement with the Q sort task. We found no strong associations between any of the factors and, gender, role, age or ethnicity.
Conclusions
Our findings suggest that healthcare professionals hold viewpoints that may influence how they interact with patients during health checks. When implementing programmes like the NHS Health Check, it would be useful to take healthcare professionals’ views into account. Attitudes and beliefs could be explored during training sessions, for example.
doi:10.1186/1471-2296-14-172
PMCID: PMC3870972  PMID: 24229342
Healthcare professional attitudes; Lifestyle advice; Primary health care; Prevention; Cardiovascular diseases; Health behaviour; Nursing; General practitioner; Q methodology
22.  Engaging GPs in insulin therapy initiation: a qualitative study evaluating a support program in the Belgian context 
BMC Family Practice  2014;15:144.
Background
A program supporting the initiation of insulin therapy in primary care was introduced in Belgium, as part of a larger quality improvement project on diabetes care. This paper reports on a study exploring factors influencing the engagement of general practitioners (GPs) in insulin therapy initiation (research question 1) and exploring factors relevant for future program development (research question 2).
Methods
We have used semi-structured interviews to answer the first research question: two focus group interviews with GPs who had at least one patient in the insulin initiation program and 20 one-to-one interviews with GPs who were not regular users of the overall support program in the region. To explore factors relevant for future program development, the data from the GPs were triangulated with data obtained from individual interviews with patients (n = 10), the diabetes nurse educator (DNE) and the specialist involved in the program, and data extracted from meeting reports evaluating the insulin initiation support program.
Results
We found differences between GPs engaged and those not engaged in insulin initiation in attitude, subjective norm and perceived behavioural control regarding insulin initiation. In general the support program was evaluated in a positive way by users of the program. Some aspects need further consideration: job boundaries between the DNE and GPs, job boundaries between GPs and specialists, protocol adherence and limited case load.
Conclusion
The study shows that the transition of insulin initiation from secondary care to the primary care setting is a challenge. Although a support program addressing known barriers to insulin initiation was provided, a substantial number of GPs were reluctant to engage in this aspect of care. Important issues for future program development are: an interdisciplinary approach to job clarification, a dynamic approach to the integration of expertise in primary care and feedback on protocol adherence.
Trial registration
ClinicalTrials.gov Identifier: NCT00824499
doi:10.1186/1471-2296-15-144
PMCID: PMC4236553  PMID: 25145469
Type 2 diabetes; Insulin therapy; Primary care
23.  Healthcare providers’ knowledge, experience and challenges of reporting adverse events following immunisation: a qualitative study 
Background
Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to surveillance systems. The aim of this study was explore the knowledge, experience and attitudes of medical and nursing professionals towards detecting and reporting AEFI.
Methods
We conducted a qualitative study, using semi-structured, face to face interviews with 13 Paediatric Emergency Department consultants from a tertiary paediatric hospital, 10 General Practitioners, 2 local council immunisation and 4 General Practice nurses, recruited using purposive sampling in Adelaide, South Australia, between December 2010 and September 2011. We identified emergent themes related to previous experience of an AEFI in practice, awareness and experience of AEFI reporting, factors that would facilitate or impede reporting and previous training in vaccine safety. Thematic analysis was used to analyse the data.
Results
AEFI reporting was infrequent across all groups, despite most participants having reviewed an AEFI. We found confusion about how to report an AEFI and variability, according to the provider group, as to the type of events that would constitute a reportable AEFI. Participants’ interpretation of a “serious” or “unexpected” AEFI varied across the three groups. Common barriers to reporting included time constraints and unsatisfactory reporting processes. Nurses were more likely to have received formal training in vaccine safety and reporting than medical practitioners.
Conclusions
This study provides an overview of experience and beliefs of three healthcare professional groups in relation to identifying and reporting AEFI. The qualitative assessment reveals differences in experience and awareness of AEFI reporting across the three professional groups. Most participants appreciated the importance of their role in AEFI surveillance and monitoring the ongoing safety of vaccines. Future initiatives to improve education, such as increased training to health care providers, particularly, medical professionals, are required and should be included in both undergraduate curricula and ongoing, professional development.
doi:10.1186/1472-6963-13-313
PMCID: PMC3751761  PMID: 23945045
Adverse event following immunisation (AEFI), Surveillance; Healthcare provider; Reporting; Qualitative
24.  Supporting self-management after attending a structured education programme: a qualitative longitudinal investigation of type 1 diabetes patients’ experiences and views 
BMC Public Health  2012;12:652.
Background
Structured education programmes for patients with diabetes and other chronic conditions are being widely adopted. However, follow-up studies suggest that course graduates may struggle to sustain the self-care practices taught on their courses over time. This study explored the support needs of patients with type 1 diabetes after attending a structured education programme promoting an empowerment approach and training in use of flexible intensive insulin therapy, a regimen now widely advocated and used to manage this condition. The objective was to inform future support offered to course graduates.
Methods
Repeat, in-depth interviews with 30 type 1 diabetes patients after attending Dose Adjustment for Normal Eating (DAFNE) courses in the UK, and six and 12 months later. Data were analysed using an inductive, thematic approach.
Results
While the flexible intensive insulin treatment approach taught on DAFNE courses was seen as a logical and effective way of managing one’s diabetes, it was also considered more technically complex than other insulin regimens. To sustain effective disease self-management using flexible intensive insulin treatment over time, patients often expected, and needed, on-going input and support from health care professionals trained in the approach. This included: help determining insulin dose adjustments; reassurance; and, opportunities to trouble-shoot issues of concern. While some benefits were identified to receiving follow-up support in a group setting, most patients stated a preference or need for tailored and individualised support from appropriately-trained clinicians, accessible on an ‘as and when needed’ basis.
Conclusions
Our findings highlight potential limitations to group-based forms of follow-up support for sustaining diabetes self-management. To maintain the clinical benefits of structured education for patients with type 1 diabetes over time, course graduates may benefit from and prefer ongoing, one-to-one support from health care professionals trained in the programme’s practices and principles. This support should be tailored and personalised to reflect patients’ specific and unique experiences of applying their education and training in the context of their everyday lives, and could be the subject of future research.
doi:10.1186/1471-2458-12-652
PMCID: PMC3490905  PMID: 22891794
25.  Roles and relationships between health professionals involved in insulin initiation for people with type 2 diabetes in the general practice setting: a qualitative study drawing on relational coordination theory 
BMC Family Practice  2014;15:20.
Background
The majority of care for people with type 2 diabetes occurs in general practice, however when insulin initiation is required it often does not occur in this setting or in a timely manner and this may have implications for the development of complications. Increased insulin initiation in general practice is an important goal given the increasing prevalence of type 2 diabetes and a relative shortage of specialists. Coordination between primary and secondary care, and between medical and nursing personnel, may be important in achieving this. Relational coordination theory identifies key concepts that underpin effective interprofessional work: communication which is problem solving, timely, accurate and frequent and relationships between professional roles which are characterized by shared goals, shared knowledge and mutual respect. This study explores roles and relationships between health professionals involved in insulin initiation in order to gain an understanding of factors which may impact on this task being carried out in the general practice setting.
Method
21 general practitioners, practice nurses, diabetes nurse educators and physicians were purposively sampled to participate in a semi-structured interview. Transcripts of the interviews were analysed using framework analysis.
Results
There were four closely interlinked themes identified which impacted on how health professionals worked together to initiate people with type 2 diabetes on insulin: 1. Ambiguous roles; 2. Uncertain competency and capacity; 3. Varying relationships and communication; and 4. Developing trust and respect.
Conclusions
This study has shown that insulin initiation is generally recognised as acceptable in general practice. The role of the DNE and practice nurse in this space and improved communication and relationships between health professionals across organisations and levels of care are factors which need to be addressed to support this clinical work. Relational coordination provides a useful framework for exploring these issues.
doi:10.1186/1471-2296-15-20
PMCID: PMC3909758  PMID: 24479762
Relational coordination; General practice; Insulin initiation; Type 2 diabetes; Roles

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