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1.  Relationship between Depression and Treatment Satisfaction among Patients with Type 2 Diabetes 
Journal of diabetes & metabolism  2012;3(7):1000210.
Background
Depression has been shown to adversely affect glycemic control. The purpose of this study is to examine the association between depression and treatment satisfaction in patients with diabetes.
Materials and methods
Baseline data was collected on 545 patients with poorly controlled type 2 diabetes enrolled in a study that examined the effectiveness of diabetes nurse case managers. Depression was measured using the Center for Epidemiologic Studies Depression (CES-D) questionnaire, and treatment satisfaction, using the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Results
The majority of participants (59%) were female, with a high percentage (41%) of Hispanic/Latino participants with a mean HbA1C of 8.4%. The prevalence of depression in this population was 35.6%. High CES-D scores were associated with elevated levels of HbA1C and LDL cholesterol (p<0.001). The relationship between depression and treatment satisfaction was significant (p<0.001), indicating that as depression increases, treatment satisfaction decreases.
Discussion
We identified a significant relationship between depression and treatment satisfaction in this group of poorly controlled type 2 diabetes patients. Although causation cannot be determined, it is possible that patients who are depressed are less likely to be satisfied with their treatment. This could lead to decreased patient adherence, ultimately resulting in poor glycemic control.
doi:10.4172/2155-6156.1000210
PMCID: PMC3521162  PMID: 23243556
Depression; Treatment satisfaction; Type 2 diabetes
2.  The impact of knowledge about diabetes, resilience and depression on glycemic control: a cross-sectional study among adolescents and young adults with type 1 diabetes 
Background
The purpose of this study is to evaluate the relationship between glycemic control and the factors of knowledge about diabetes, resilience, depression and anxiety among Brazilian adolescents and young adults with type 1 diabetes.
Methods
This cross-sectional study included 85 adolescents and young adults with type 1 diabetes, aged between 11–22 years, with an average age of 17.7 ± 3.72 years. Glycemic control degree was evaluated through HbA1c. To assess psychosocial factors, the following questionnaires were used: resilience (Resilience Scale, RS) and anxiety and depression (Hospital Anxiety and Depression Scale, HADS). The Diabetes Knowledge Assessment Scale (DKNA) was used to assess knowledge about diabetes.
Results
Significant correlations were found between HbA1c and resilience, anxiety and depression. Multiple linear regression analysis revealed that the only variable which presented significant association with the value of HbA1c was depression.
Conclusions
Depression has a significant association with higher HbA1c levels, as demonstrated in a regression analysis. The results suggest that depression, anxiety and resilience should be considered in the design of a multidisciplinary approach to type 1 diabetes, as these factors were significantly correlated with glycemic control. Glycemic control was not correlated with knowledge of diabetes, suggesting that theoretical or practical understanding of this disease is not by itself significantly associated with appropriate glycemic control (HbA1c ≤ 7.5%).
doi:10.1186/1758-5996-5-55
PMCID: PMC3849685  PMID: 24289093
Glycemic control; Type 1 diabetes; Psychosocial factors; Depression; Resilience
3.  Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study 
Diabetic Medicine  2011;28(6):715-723.
Aims
The Liraglutide Effect and Action in Diabetes 6 trial was an open-label trial comparing liraglutide with exenatide as an ‘add-on’ to metformin and/or sulphonylurea.
Methods
Patients with Type 2 diabetes were randomized to liraglutide 1.8 mg once daily or exenatide 10 μg twice daily for 26 weeks. This was followed by a 14-week extension phase, in which all patients received liraglutide 1.8 mg once daily.
Results
Patient-reported outcomes were measured in 379 patients using Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and DTSQ change (DTSQc). The change in overall treatment satisfaction (DTSQs score) from baseline at week 26 with liraglutide was 4.71 and with exentaide was 1.66 [difference between groups 3.04 (95% CI 1.73–4.35), P < 0.0001]. Five of the six items on the DTSQs improved significantly more with liraglutide than with exenatide (differences: current treatment 0.37, P = 0.0093; convenience 0.68, P < 0.0001; flexibility 0.57, P = 0.0002; recommend 0.49, P = 0.0003; continue 0.66, P = 0.0001). Patients perceived a greater reduction in hypoglycaemia at week 26 with liraglutide than with exenatide [difference in DTSQc score 0.48 (0.08–0.89), P = 0.0193] and a greater reduction in perceived hyperglycaemia [difference 0.74 (0.31–1.17), P = 0.0007]. During the extension phase, when all patients received liraglutide, DTSQs scores remained stable in patients who continued on liraglutide and increased significantly (P = 0.0026) in those switching from exenatide.
Conclusions
These results demonstrate significant improvements in patients’ treatment satisfaction with liraglutide compared with exenatide.
doi:10.1111/j.1464-5491.2011.03276.x
PMCID: PMC3123703  PMID: 21388442
exenatide; liraglutide; patient-reported outcomes; Type 2 diabetes
4.  Psychometric properties of the Greek Diabetes Treatment Satisfaction Questionnaire 
Objectives
Measurement of treatment satisfaction in diabetes is important as it has been shown to be associated with positive outcomes, reduced disease cost and better health. The aim of this study was to assess the construct validity and internal consistency reliability of the Greek version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Methods
A sample of type II diabetes patients (N = 172) completed the DTSQ status version, the SF-36 health survey and also provided data regarding treatment method, clinical and socio-demographic status. Instrument structure, reliability (Cronbach's a) and construct validity (convergent, discriminative, concurrent and known-groups) were assessed.
Results
The DTSQ measurement properties were confirmed in the Greek version with confirmatory factor analysis (CFA). Scale reliability was high (Cronbach's a = 0.92). Item-scale internal consistency and discriminant validity were also good, exceeding the designated success criteria. Significant correlations were observed between DTSQ items/overall score and SF-36 scales/component scores, which were hypothesized to measure similar dimensions. Known groups' comparisons yielded consistent support of the construct validity of the instrument.
Conclusions
The instrument was well-accepted by the patients and its psychometric properties were similar to those reported in validation studies of other language versions. Further research, incorporating a longitudinal study design, is required for examining test-retest reliability and responsiveness of the instrument, which were not addressed in this study. Overall, the present results confirm that the DTSQ status version is a reasonable choice for measuring diabetes treatment satisfaction in Greece.
doi:10.1186/1477-7525-10-17
PMCID: PMC3292919  PMID: 22296783
diabetes; DTSQ; treatment satisfaction; validity; reliability; Greece
5.  Patients' Perception and Future Acceptance of an Artificial Pancreas 
Background
Little is known of patient acceptance of an artificial pancreas (AP). The purpose of this study was to investigate future acceptance of an AP and its determinants.
Methods
Patients with type 1 diabetes treated with insulin pump therapy were interviewed using questions based on the technology acceptance model and completed the diabetes treatment and satisfaction questionnaire (DTSQ).
Results
Twenty-two adults with type 1 diabetes participated. Half of the patients were followed in a university hospital, and the others were under treatment in an affiliated teaching hospital. Half of the patients were male. The mean DTSQ score was 29 (range 23–33). The AP was perceived as likely to be useful. Perceived advantages were a stable glucose regulation, less need for self-monitoring of blood glucose, relief of daily concerns, and time saving. Participants were confident in their capability to use the system. Although many participants (58%) had been reluctant to start continuous subcutaneous insulin infusion, the majority (79%) felt they would have no barriers to start using the AP. Trust in the AP was related to the quality of glucose control it would provide. Almost everyone expressed the intention to use the new system when available, even if it would initially not cover 24/24 hours.
Conclusion
The overall attitude on the AP was positive. Intention to use was dependent on trust in the AP, which was related to the quality of glucose control provided by the AP.
PMCID: PMC2901036  PMID: 20513325
acceptance; artificial pancreas; perception; type 1 diabetes mellitus
6.  Prevalence of depression among people with type 2 diabetes mellitus: a cross sectional study in Palestine 
BMC Public Health  2014;14:163.
Background
Diabetes mellitus is a common chronic metabolic disorder and one of the main causes of death in Palestine. Palestinians are continuously living under stressful economic and military conditions which make them psychologically vulnerable. The purpose of this study was to investigate the prevalence of depression among type II diabetic patients and to examine the relationship between depression and socio-demographic factors, clinical factors, and glycemic control.
Methods
This was a cross-sectional study at Al-Makhfiah primary healthcare center, Nablus, Palestine. Two hundred and ninety-four patients were surveyed for the presence of depressive symptoms using Beck Depression Inventory (BDI-II) scale. Patients' records were reviewed to obtain data pertaining to age, sex, marital status, Body Mass Index (BMI), level of education, smoking status, duration of diabetes mellitus, glycemic control using HbA1C test, use of insulin, and presence of additional illnesses. Patients’ medication adherence was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8).
Results
One hundred and sixty four patients (55.8%) of the total sample were females and 216 (73.5%) were < 65 years old. One hundred and twenty patients (40.2%) scored ≥ 16 on BDI-II scale. Statistical significant association was found between high BDI-II score (≥ 16) and female gender, low educational level, having no current job, having multiple additional illnesses, low medication adherence and obesity (BMI ≥ 30 kg/m2). No significant association between BDI score and glycemic control, duration of diabetes, and other socio-demographic factors was found. Multivatriate analysis showed that low educational level, having no current job, having multiple additional illnesses and low medication adherence were significantly associated with high BDI-II scores.
Conclusion
Prevalence of depression found in our study was higher than that reported in other countries. Although 40% of the screened patients were potential cases of depression, none were being treated with anti-depressants. Psychosocial assessment should be part of routine clinical evaluation of these patients at primary healthcare clinics to improve quality of life and decrease adverse outcomes among diabetic patients.
doi:10.1186/1471-2458-14-163
PMCID: PMC3929146  PMID: 24524353
Diabetes mellitus; Depression; Palestine
7.  Self-report and parent-report of physical and psychosocial well-being in Dutch adolescents with type 1 diabetes in relation to glycemic control 
Background
To determine physical and psychosocial well-being of adolescents with type 1 diabetes by self-report and parent report and to explore associations with glycemic control and other clinical and socio-demographic characteristics.
Methods
Demographic, medical and psychosocial data were gathered from 4 participating outpatient pediatric diabetes clinics in the Netherlands. Ninety-one patients completed the Child Health Questionnaire-CF87 (CHQ-CF87), Centre for Epidemiological Studies scale for Depression (CES-D), and the DFCS (Diabetes-specific Family Conflict Scale). Parents completed the CHQ-PF50, CES-D and the DFCS.
Results
Mean age was 14.9 years (± 1.1), mean HbA1c 8.8% (± 1.7; 6.2–15.0%). Compared to healthy controls, patients scored lower on CHQ subscales role functioning-physical and general health. Parents reported less favorable scores on the behavior subscale than adolescents. Fewer diabetes-specific family conflicts were associated with better psychosocial well-being and less depressive symptoms. Living in a one-parent family, being member of an ethnic minority and reporting lower well-being were all associated with higher HbA1c values.
Conclusion
Overall, adolescents with type 1 diabetes report optimal well-being and parent report is in accordance with these findings. Poor glycemic control is common, with single-parent families and ethnic minorities particularly at risk. High HbA1c values are related to lower social and family functioning.
doi:10.1186/1477-7525-5-10
PMCID: PMC1802741  PMID: 17306021
8.  Psychometric validation of the Self-Care Inventory-Revised (SCI-R) in UK adults with type 2 diabetes using data from the AT.LANTUS Follow-on study 
Background
Achieving optimal outcomes in type 2 diabetes (T2DM) involves several demanding self-care behaviours, e.g. managing diet, activity, medications, monitoring glucose levels, footcare. The Self-Care Inventory-Revised (SCI-R) is valid for use in people with T2DM in the US. Our aim was to determine its suitability for use in the UK.
Methods
353 people with T2DM participated in the AT.LANTUS Follow-on study, completing measures of diabetes self-care (SCI-R), generic and diabetes-specific well-being (W-BQ28), and diabetes treatment satisfaction (DTSQ). Statistical analyses were conducted to explore structure, reliability, and validity of the SCI-R.
Results
Principal components analysis indicated a 13-item scale (items loading >0.39) with satisfactory internal consistency reliability (α = 0.77), although neither this model nor any alternatives were confirmed in the confirmatory factor analysis. Acceptability was high (>95% completion for all but one item); ceiling effects were demonstrated for six items. As expected, convergent validity (correlations between self-care behaviours) was found for few items. Divergent validity was supported by expected low correlations between SCI-R total and well-being (rs = 0.02-0.21) and treatment satisfaction (rs = 0.29). Known-groups validity was partially supported with significant differences in SCI-R total by HbA1c (≤7.5% (58 mmol/mol): 72 ± 11, >7.5% (58 mmol/mol): 68 ± 14, p < 0.05) and diabetes duration (≤16 years: 67 ± 13, >16 years: 71 ± 12, p < 0.001) but not by presence/absence of complications or by insulin treatment algorithm.
Conclusions
The SCI-R is a brief, valid and reliable measure of self-care in people with T2DM in the UK. However, ceiling effects raise concerns about its potential for responsiveness in clinical trials. Individual items may be more useful clinically than the total score.
doi:10.1186/1477-7525-11-24
PMCID: PMC3608221  PMID: 23443007
Type 2 diabetes; Psychometric validation; Questionnaire; Self-care; Self-management; SCI-R; AT.LANTUS trial
9.  Diabetes Distress but Not Clinical Depression or Depressive Symptoms Is Associated With Glycemic Control in Both Cross-Sectional and Longitudinal Analyses 
Diabetes Care  2009;33(1):23-28.
OBJECTIVE
To determine the concurrent, prospective, and time-concordant relationships among major depressive disorder (MDD), depressive symptoms, and diabetes distress with glycemic control.
RESEARCH DESIGN AND METHODS
In a noninterventional study, we assessed 506 type 2 diabetic patients for MDD (Composite International Diagnostic Interview), for depressive symptoms (Center for Epidemiological Studies-Depression), and for diabetes distress (Diabetes Distress Scale), along with self-management, stress, demographics, and diabetes status, at baseline and 9 and 18 months later. Using multilevel modeling (MLM), we explored the cross-sectional relationships of the three affective variables with A1C, the prospective relationships of baseline variables with change in A1C over time, and the time-concordant relationships with A1C.
RESULTS
All three affective variables were moderately intercorrelated, although the relationship between depressive symptoms and diabetes distress was greater than the relationship of either with MDD. In the cross-sectional MLM, only diabetes distress but not MDD or depressive symptoms was significantly associated with A1C. None of the three affective variables were linked with A1C in prospective analyses. Only diabetes distress displayed significant time-concordant relationships with A1C.
CONCLUSIONS
We found no concurrent or longitudinal association between MDD or depressive symptoms with A1C, whereas both concurrent and time-concordant relationships were found between diabetes distress and A1C. What has been called “depression” among type 2 diabetic patients may really be two conditions, MDD and diabetes distress, with only the latter displaying significant associations with A1C. Ongoing evaluation of both diabetes distress and MDD may be helpful in clinical settings.
doi:10.2337/dc09-1238
PMCID: PMC2797978  PMID: 19837786
10.  Response shift and glycemic control in children with diabetes 
Background
The purpose of this study was to investigate the scale recalibration construct of response shift and its relationship to glycemic control in children with diabetes.
Methods
At year 1, thirty-eight children with type 1 diabetes attending a diabetes summer camp participated. At baseline and post-camp they completed the Problem Areas in Diabetes (PAID) questionnaire. Post-camp, the PAID was also completed using the 'thentest' method, which requires a retrospective judgment about their baseline functioning. At year 2, fifteen of the original participants reported their HbA1c.
Results
PAID scores significantly decreased from baseline to post-camp. An even larger difference was found between thentest and post-camp scores, suggesting scale recalibration. There was a significant positive correlation between year 1 HbA1c and thentest scores. Partial correlation analysis between PAID thentest scores and year 2 HbA1c, controlling for year 1 HbA1c, showed that higher PAID thentest scores were associated with higher year 2 HbA1c.
Conclusion
Results from this small sample suggest that children with diabetes do show scale recalibration, and that it may be related to glycemic control.
doi:10.1186/1477-7525-3-38
PMCID: PMC1180844  PMID: 15955236
11.  Effect of Intensive Glycemic Lowering on Health-Related Quality of Life in Type 2 Diabetes 
Diabetes Care  2011;34(4):807-812.
OBJECTIVE
To compare the effect of intensive versus standard glycemic control strategies on health-related quality of life (HRQL) in a substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
RESEARCH DESIGN AND METHODS
A randomly selected subsample of 2,053 ACCORD participants enrolled in the HRQL substudy was assessed at baseline and 12-, 36-, and 48-month visits. HRQL assessment included general health status (the 36-Item Short Form Health Survey [SF-36]), diabetes symptoms (the Diabetes Symptom Distress Checklist), depression (Patient Health Questionnaire [PHQ]-9), and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Repeated-measures ANOVA models were used to estimate change in HRQL outcomes by treatment group over 48 months adjusting for model covariates. The effects of early discontinuation of the ACCORD intensive glycemic control arm on study results were explored.
RESULTS
A total of 1,956 (95%) completed the self-report HRQL instrument(s) at baseline. The intensive arm had a larger decrease in SF-36 physical health component score than the standard arm (−1.6 vs. −1.1, P = 0.0345). Treatment satisfaction (DTSQ) showed larger improvement with intensive than standard (P = 0.0004). There were no differences in mean scores of the Diabetes Symptom Checklist and PHQ-9. Effects of participant transition following discontinuation of the intensive arm on HRQL were not significant.
CONCLUSIONS
The ACCORD trial strategy of intensive glycemic control did not lead to benefits in HRQL and was associated with modest improvement in diabetes treatment satisfaction. Thus patient acceptability was apparently not compromised with intensive and complex interventions such as those used in ACCORD.
doi:10.2337/dc10-1926
PMCID: PMC3064032  PMID: 21346183
12.  The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ 
Background
The results of using status measures to identify any changes in treatment satisfaction strongly suggest a need for specific change instruments designed to overcome the ceiling effects frequently observed at baseline. Status measures may leave little room to show improvement in situations where baseline ceiling effects are observed. A change version of the DTSQ (DTSQc) is compared here with the original status (now called DTSQs) version to test the instruments' comparative ability to demonstrate change.
Methods
Two multinational, openlabel, randomised-controlled trials (one for patients with type 1 diabetes, the other for type 2) compared new, longer-acting insulin glargine with standard NPH basal insulin. The DTSQs was completed at baseline and the DTSQs and DTSQc at final visit by 351 English- and German-speaking patients. DTSQc scores were compared with change from baseline for the DTSQs, using 3-way analysis of variance, to examine Questionnaire, Treatment and Ceiling effects (i.e. baseline scores at/near ceiling).
Results and discussion
Significant Questionnaire effects and a Questionnaire × Ceiling interaction (p < 0.001) in both trial datasets showed that the DTSQc detected more improvement in Treatment Satisfaction than the DTSQs, especially when patients had DTSQs scores at/near ceiling at baseline. Additionally, significant Treatment effects favouring insulin glargine (p < 0.001) and a Treatment × Questionnaire interaction (p < 0.019), with the DTSQc showing more benefits, were found in the type 1 trial. Results for Perceived Hyper- and Hypoglycaemia also demonstrated important differences between the questionnaires in the detection of treatment effects. Tests of effect sizes showed these differences in response to change to be significantly in favour of the DTSQc.
Conclusion
The DTSQc, used in conjunction with the DTSQs, overcomes the problem of ceiling effects encountered when only the status measure is used and provides a means for new treatments to show greater value than is possible with the DTSQs alone.
doi:10.1186/1477-7525-5-57
PMCID: PMC2170436  PMID: 17927832
13.  The Association of Cognitive Function and Social Support with Glycemic Control in Adults with Diabetes 
OBJECTIVES
To examine whether cognitive impairment among adults with diabetes is associated with worse glycemic control and to assess if level of social support for diabetes care modifies this relationship.
DESIGN
Cross-sectional analysis
SETTING
The 2003 Health and Retirement Study (HRS) Mail Survey on Diabetes and the 2004 wave of the HRS
PARTICIPANTS
Adults age > 50 with diabetes in the United States (N=1097, mean age=69.2)
MEASUREMENTS
Hemoglobin A1c (HbA1c) level, cognitive function measured with the 35-point HRS cognitive scale (HRS-cog), sociodemographic variables, duration of diabetes, depressed mood, social support for diabetes care, self-reported understanding score of diabetes knowledge, diabetes treatments, diabetes-related components of the Total Illness Burden Index, and functional limitations.
RESULTS
In an ordered logistic regression model for the three ordinal levels of HbA1c (<7.0, 7.0–7.9, ≥8.0 mg/dl), respondents with HRS-cog scores in the lowest quartile had significantly higher HbA1c levels compared to those in the highest cognitive quartile (adjusted odds ratio, 1.80; 95% confidence interval, 1.11–2.92). This association was modified by a high level of social support for diabetes care: among respondents in the lowest cognitive quartile, those with high levels of support had significantly lower odds of having higher HbA1c compared to those with low levels of support (1.11 vs. 2.87, p=0.016).
CONCLUSION
Although cognitive impairment was associated with worse glycemic control, higher levels of social support for diabetes care ameliorated this negative relationship. Identifying the level of social support available to cognitively-impaired adults with diabetes may help to target interventions for better glycemic control.
doi:10.1111/j.1532-5415.2009.02431.x
PMCID: PMC2810258  PMID: 19682129
cognitive impairment; glycemic control; diabetes mellitus; social support
14.  Racial differences in diabetes-related psychosocial factors and glycemic control in patients with type 2 diabetes 
Background:
We examined whether diabetes-related psychosocial factors differ between African American and white patients with type 2 diabetes. We also tested whether racial differences in glycemic control are independent of such factors.
Methods:
Baseline glycosylated hemoglobin (HbA1c) and survey measures from 79 African American and 203 white adult participants in a diabetes self-management clinical trial were analyzed.
Results:
Several psychosocial characteristics varied by race. Perceived interference of diabetes with daily life, perceived diabetes severity, and diabetes-related emotional distress were higher for African Americans than for whites, as were access to illness-management resources and social support. Mean HbA1c levels were higher among African Americans than whites (8.14 vs 7.40, beta = 0.17). This difference persisted after adjusting for demographic, clinical, and diabetes-related psychosocial characteristics that differed by race (beta = 0.18). Less access to illness-management resources (beta = −0.25) and greater perceived severity of diabetes (beta = 0.21) also predicted higher HbA1c.
Discussion:
Although racial differences in diabetes-related psychosocial factors were observed, African Americans continued to have poorer glycemic control than whites even after such differences were taken into account. Interventions that target psychosocial factors related to diabetes management, particularly illness-management resources, may be a promising way to improve glycemic control for all patients.
PMCID: PMC2943221  PMID: 20859456
diabetes mellitus; type 2; minority health; health status disparities; psychosocial factors; disease management
15.  Factors Associated With Psychological Insulin Resistance in Individuals With Type 2 Diabetes 
Diabetes Care  2010;33(8):1747-1749.
OBJECTIVE
To describe the predictive relationships of selected sociodemographic, biomedical, and psychosocial variables to reluctance to use insulin among patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS
A total of 178 patients with type 2 diabetes participated in this cross-sectional, observational study. Data were obtained by patient interview using validated measures of diabetes attitude, knowledge, self-efficacy, care communication, and perceived barriers to treatment, as well as sociodemographic and biomedical data.
RESULTS
Women and ethnic minorities with type 2 diabetes have more psychological barriers to insulin treatment (P < 0.05). The final regression model showed that individuals who believed in the value of tight glucose control, had strong self-efficacy, and had better interpersonal processes with their healthcare providers were less reluctant to use insulin treatment (R2 = 0.403; P < 0.0001).
CONCLUSIONS
Diabetes self-efficacy and better interaction with clinicians were important in decreasing patients' reluctance to use insulin, known as psychological insulin resistance.
doi:10.2337/dc10-0099
PMCID: PMC2909055  PMID: 20435797
16.  Clinical study of treatment switching from premixed insulin to basal insulin combined with oral hypoglycemic drugs in patients with type 2 diabetes 
Aim
Premixed insulin regimens are commonly used for the treatment of patients with type-2 diabetes mellitus (T2DM). However, limited data are available regarding next-step therapy options in cases where premixed insulin fails to provide adequate glycemic control. This 20-week observational study of everyday clinical practice evaluated the efficacy, safety and treatment satisfaction of insulin glargine plus oral anti-diabetic drugs (OADs) in T2DM patients previously treated with premixed insulin.
Methods
In this open-label, single-arm, 20-week study, 70 subjects with T2DM inadequately controlled with premixed insulin were switched to insulin glargine plus OADs. Changes in glycaemic control, incidence of hypoglycaemia, treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (DTSQ), serum superoxide dismutase (SOD), and serum 8-iso-prostaglandin (8-iso-PG) were evaluated at the start and the end of the study.
Results
Over the 20 week treatment period, mean (±SD) HbA1c levels decreased from 8.28 ± 1.24% to 6.83 ± 1.09%, mean (±SD) FBG levels decreased from 7.64 ± 1.36 mmol/L to 5.57 ± 1.21 mmol/L, and 2 h PBG levels decreased from 12.07 ± 1.17 mmol/L to 8.94 ± 1.56 mmol/L, all P < 0.001. A total of 3 symptomatic hypoglycemic episodes were reported. No significant reductions in body weight were observed. The mean daily dose of insulin decreased by 14 U between week 0 (30.20 ± 9.93 U) and week 20 (16.38 ± 5.15 U). The total treatment satisfaction score showed a significant increase from study baseline to end point. Significant increases in SOD(90.00 ± 16.62 to 108.81 ± 27.02 u/ml, P < 0.01) and reductions in 8-iso-PG(2.15 ± 0.61 to 1.64 ± 0.42 pg/ml, P < 0.05) were observed between the start and end of the observation period. There were significant differences in baseline HbA1c, duration of diabetes, and baseline postprandial C-peptide between the A1c ≤ 6.5% group and the A1c > 7.0% group [HbA1c: 7.25% ± 1.02% vs. 9.32% ± 1.23%; duration: 7.84 ± 1.02 vs. 13.96 ± 1.35 years; postprandial C-peptide: 4.83 ± 2.11 vs 2.54 ± 0.87 nmol/L, all P < 0.05].
Conclusions
The observational study shows that, in T2DM patients inadequately controlled with premixed insulin, switching therapy to glargine plus OADs is associated with significant improvements in glycaemic control and treatment satisfaction, and is with low incidence of hypoglycemia. Baseline postprandial C-peptide, HbA1c, and duration of diabetes are the key factors closely related to efficacy of this treatment regimen.
doi:10.1186/1758-5996-6-37
PMCID: PMC3984683  PMID: 24620742
Type 2 diabetes mellitus; Glargine; Premixed insulin; Oxidative stress
17.  Changes in Diabetes Distress Related to Participation in an Internet-Based Diabetes Care Management Program and Glycemic Control 
Background
This article investigated how changes in diabetes distress relate to receiving care management through an Internet-based care management (IBCM) program for diabetes and level of participation in this program. Further, it examined the relationship between diabetes distress and changes in glycemic control.
Methods
We enrolled patients of the Veterans Affairs Boston Healthcare System with diabetes who had hemoglobin A1c (HbA1c) levels of ≥9.0%. Subjects were randomized to usual care (n = 52) or IBCM (n = 52) for 1 year. We measured diabetes distress at baseline and quarterly thereafter using the Problem Areas in Diabetes (PAID) questionnaire. Glycemic control was determined by baseline and quarterly HbA1c. For subjects randomized to IBCM, we measured participation by observing frequency and consistency of their usage of the IBCM patient portal over 12 months. Linear mixed models were used to analyze THE data.
Results
PAID scores declined over time for both treatment groups. Among subjects randomized to IBCM, the decline in PAID scores over time was significant for sustained users of the IBCM patient portal but not for nonusers. Moreover, subjects whose usage of the patient portal was sustained throughout the study had lower PAID scores at baseline. With respect to changes in glycemic control, HbA1c reduced individual differences in PAID scores by 44%; a lower baseline HbA1c was associated with lower baseline PAID scores, and over time, the decrease in HbA1c was associated with further decreases in the PAID score.
Conclusions
Participation in IBCM varies by initial diabetes distress, with people with less distress participating more. For people who participate, IBCM further mitigates diabetes distress. There is also a relationship between achievements in glycemic control and subsequent lowering of diabetes distress. Future research should identify how to maximize fit between patient needs and the provisions of IBCM, with the aim of increasing patient engagement in the active management of their health using this care modality. A key to maximizing fit might be first addressing metabolic control aggressively and then using IBCM for sustainment of health.
PMCID: PMC2769854  PMID: 20046656
diabetes distress; disease management; Internet; PAID scale; patient care management; psychosocial
18.  Associations Between Media Consumption Habits, Physical Activity, Socioeconomic Status, and Glycemic Control in Children, Adolescents, and Young Adults With Type 1 Diabetes 
Diabetes Care  2011;34(11):2356-2359.
OBJECTIVE
To evaluate the relationship between media consumption habits, physical activity, socioeconomic status, and glycemic control in youths with type 1 diabetes.
RESEARCH DESIGN AND METHODS
In the cross-sectional study, self-report questionnaires were used to assess media consumption habits, physical activity, and socioeconomic status in 296 children, adolescents, and young adults with type 1 diabetes. Clinical data and HbA1c levels were collected. Risk factors were analyzed by multiple regression.
RESULTS
Youths with type 1 diabetes (aged 13.7 ± 4.1 years, HbA1c 8.7 ± 1.6%, diabetes duration 6.1 ± 3.3 years) spent 2.9 ± 1.8 h per day watching television and using computers. Weekly physical activity was 5.1 ± 4.5 h. Multiple regression analysis identified diabetes duration, socioeconomic status, and daily media consumption time as significant risk factors for glycemic control.
CONCLUSIONS
Diabetes duration, socioeconomic status, and daily media consumption time, but not physical activity, were significant risk factors for glycemic control in youths with type 1 diabetes.
doi:10.2337/dc11-0838
PMCID: PMC3198300  PMID: 21926289
19.  Prospective Associations Between Emotional Distress and Poor Outcomes in Type 2 Diabetes 
Diabetes Care  2012;35(12):2472-2478.
OBJECTIVE
Cross-sectional studies link both depressive symptoms (DS) and diabetes-related distress (DRD) to diabetes self-management and/or glycemic control. However, longitudinal studies of these variables are rare, and their results are somewhat conflicting. The study objective was to compare DS and DRD as longitudinal predictors of medication adherence, self-care behavior, and glycemic control in type 2 diabetes.
RESEARCH DESIGN AND METHODS
Primary care patients with type 2 diabetes reported DS, DRD, and other variables at baseline were studied. Medication adherence, self-care behaviors (diet, physical activity, and glucose testing), and glycemic control (HbA1c) were assessed 6 months later (n = 253). Cross-sectional and longitudinal regression analyses were used to model behavioral and medical outcomes as a function of baseline confounders, DS, and DRD.
RESULTS
Adjusted cross-sectional and longitudinal analyses yielded very similar results. In the latter, only DS were significantly associated with future diet behavior (P = 0.049), physical activity (P = 0.001), and glucose testing (P = 0.018). In contrast, only DRD predicted future glycemic control (P < 0.001) and medication adherence (P = 0.011).
CONCLUSIONS
Distress-outcome associations seem to vary by type of distress under consideration. Only DS predicts future lifestyle-oriented self-management behaviors. In contrast, only DRD predicts glycemic control, perhaps by decreasing medication adherence. Clinical assessment and intervention should encompass both types of distress, unless the goal is to narrowly target a highly specific outcome.
doi:10.2337/dc12-0181
PMCID: PMC3507577  PMID: 23033244
20.  The influence of diabetes psychosocial attributes and self-management practices on change in diabetes status 
Objective
To examine the influence of diabetes psychosocial attributes and self-management on glycemic control and diabetes status change.
Methods
Using data from the Health and Retirement Study, a nationally-representative longitudinal study of U.S. adults > 51 years, we examined cross-sectional relationships among diabetes psychosocial attributes (self-efficacy, risk awareness, care understanding, prioritization of diabetes, and emotional distress), self-management ratings, and glycemic control. We then explored whether self-management ratings and psychosocial attributes in 2003 predicted change in diabetes status in 2004.
Results
In multivariate analyses (N = 1834), all diabetes psychosocial attributes were associated with self-management ratings, with self-efficacy and diabetes distress having the strongest relationships (adj coeff = 8.1, p < 0.01 and −4.1, p < 0.01, respectively). Lower self-management ratings in 2003 were associated cross-sectionally with higher hemoglobin A1C (adj coeff = 0.16, p < 0.01), and with perceived worsening diabetes status in 2004 (adj OR = 1.36, p < 0.05), with much of this latter relationship explained by diabetes distress.
Conclusion
Psychosocial attributes, most notably diabetes-related emotional distress, contribute to difficulty with diabetes self-management, poor glycemic control, and worsening diabetes status over time.
Practice Implications
Self-management and adherence interventions should target psychosocial attributes such as disease-related emotional distress.
doi:10.1016/j.pec.2011.07.013
PMCID: PMC3229832  PMID: 21840149
diabetes; self-management; self-efficacy; diabetes distress
21.  Adherence in adults with type 1 diabetes mellitus correlates with treatment satisfaction but not with adverse events 
Purpose
Diabetes self-care and self-monitoring adherence has a positive effect on the metabolic control of the disease. The aim of this study was to analyze the adherence to self-care recommendations and to identify its correlates in adults with type 1 diabetes mellitus.
Patients and methods
One hundred and eleven patients with type 1 diabetes were enrolled in an observational cross-sectional study conducted at the Diabetes Center of the University Hospital in Hradec Králové, Czech Republic. Diabetes self-care adherence was measured by the Self Care Inventory-Revised, and treatment satisfaction by the Diabetes Treatment Satisfaction Questionnaire-status version. Additional data were collected from self-administered questionnaires and medical records. The Mann–Whitney test, Spearman correlations, and multiple linear regressions were used in the statistical analysis.
Results
The mean age of patients was 42.4 years; 59.5% of them were females and 53.2% of all patients used an insulin pump. The mean glycosylated hemoglobin (HbA1c) was 66.2 ± 15.3 mmol/mol and the mean insulin dosage was 0.6 ± 0.3 IU insulin/kg/day. The number of hypoglycemic episodes (including severe) that patients had in the last month before taking the survey was 3.6 ± 3.2. Self-care adherence was associated with treatment satisfaction (0.495; P = 0.004) along with frequency of self-monitoring of before meal blood glucose (0.267; P = 0.003). It was not associated with the incidence of hypoglycemic events or any other insulin therapy-related problems or with socio-demographic or clinical characteristics.
Conclusion
Treatment satisfaction is one of the key factors that need to be targeted to maximize benefits to patients. Self-care adherence in adults with type 1 diabetes did not correlate with socio-demographic and clinical characteristics, nor with adverse events.
doi:10.2147/PPA.S47750
PMCID: PMC3772756  PMID: 24043930
treatment adherence; self-care inventory revised; diabetes treatment satisfaction questionnaire; self-monitoring
22.  Multicenter User Evaluation of ACCU-CHEK® Combo, an Integrated System for Continuous Subcutaneous Insulin Infusion 
Background
The aim of this study was to evaluate a newly developed system for insulin delivery incorporating a multifunctional blood glucose meter and a remotely controlled insulin pump (ACCU-CHEK® Combo system) in established pump users with type 1 diabetes. The technology was assessed both from device performance and subject usability perspectives.
Method
A multicenter, prospective, single group study was carried out in five centers in the Netherlands and four centers in the United Kingdom for more than 6 months. The study was divided into two phases: Phase 1 (4 weeks) for device validation purposes and phase 2 (22 weeks) to observe the impact of the system on metabolic control, patient satisfaction [using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)] and device safety.
Results
Eighty subjects completed the planned study period. There were no unexpected device errors. Treatment satisfaction was high at baseline and further increased to study end (DTSQ change version: sum score, 10.6 ± 7.2; scale score range, -18 to +18, p < 0.0001). Hemoglobin A1c improved continuously over time, from 7.9% (±0.9%) to 7.7% (±0.8%) at month 3 (p < 0.001) and 7.6% (±0.8%) at month 6 (p < 0.0001). The frequency of severe hypoglycemia was 0.08 per patient years. There was no case of ketoacidosis.
Conclusions
The new system was evaluated by experienced continuous subcutaneous insulin infusion users as safe in daily practice and associated with favorable treatment satisfaction and a modest improvement in glycemic control.
PMCID: PMC3005051  PMID: 21129336
bolus advice; continuous subcutaneous insulin infusion; DTSQ; HbA1c; safety; smart insulin pump; treatment satisfaction
23.  Patients’ Adherence to Anti-Diabetic Medications in a Hospital at Ajman, UAE 
Background:
Anti-diabetic medications are integral for glycemic control in diabetes. Non-adherence to drugs can alter blood glucose levels, resulting in complications. Adherence to anti-diabetic medications reported by patients and the factors associated with medication adherence among adult patients with diabetes mellitus were explored.
Methods:
This cross-sectional study was carried out among patients with type II diabetes mellitus attending the Internal Medicine Department of a hospital in the United Arab Emirates. Consecutive patients were selected, and data regarding their medication adherence were collected using a questionnaire. Data analysis was carried out using SPSS-20. The chi-square test was performed to examine the associations between categorical variables; a two-sided P Value < 0.05 was considered significant.
Results:
A total of 132 patients participated in the study (63 males; 69 females). The mean age (standard deviation) of the respondents was 54 years (SD 10.2). The self-reported adherence rate to anti-diabetic drugs was 84%. The most common reason for non-adherence was forgetfulness, and the adherence rate was similar in both genders. Patients with Bachelor’s and Master’s degree reported greater adherence rate to anti-diabetic medication in comparison to the secondary school educated.
Conclusion:
The self-reported adherence rate to anti-diabetic medications was 84%, and forgetfulness was the most common reason for non-adherence. Future studies on strategies to improve adherence rate should be considered.
PMCID: PMC3952347  PMID: 24639611
anti-diabetic drugs; compliance; diabetes mellitus; patient-physician relationship; patient adherence
24.  Pictorial Representation of Illness and Self Measure Revised II (PRISM-RII) – a novel method to assess perceived burden of illness in diabetes patients 
Background
The Pictorial Representation of Illness and Self Measure (PRISM) has been introduced as a visual measure of suffering. We explored the validity of a revised version, the PRISM-RII, in diabetes patients as part of the annual review.
Methods
Participants were 308 adult outpatients with either type 1 or type 2 diabetes. Measures: (1) the PRISM-RII, yielding Self-Illness Separation (SIS) and Illness Perception Measure (IPM); (2) the Problem Areas in Diabetes (PAID) scale, a measure of diabetes-related distress; (3) the WHO-5 Well-Being Index; (4) and a validation question on suffering (SQ). In addition, patients' complication status, comorbidity and glycemic control values(HbA1c) were recorded.
Results
Patients with complications did have marginally significant higher scores on IPM, compared to patients without complications. Type 2 patients had higher IPM scores than Type 1 patients. SIS and IPM showed low intercorrelation (r = -.25; p < .01). Convergent validity of PRISM-RII was demonstrated by significant correlations between IPM and PAID (r = 0.50; p < 0.01), WHO-5 (r = -.26; p < 0.01) and SQ (r = 0.36; p < 0.01). SIS showed only significant correlations with PAID (r = -0.28; p < 0.01) and SQ (r = -0.22; p < 0.01). Neither IPM nor SIS was significantly associated with HbA1c. The PRISM-RII appeared easy to use and facilitated discussion with care providers on coping with the burden of diabetes.
Conclusion
PRISM-RII appears a promising additional tool to assess the psychological burden of diabetes.
doi:10.1186/1477-7525-6-104
PMCID: PMC2627820  PMID: 19038050
25.  Effects of self-care, self-efficacy, social support on glycemic control in adults with type 2 diabetes 
BMC Family Practice  2013;14:66.
Background
A number of studies have examined the influence of self-efficacy, social support and patient-provider communication (PPC) on self-care and glycemic control. Relatively few studies have tested the pathways through which these constructs operate to improve glycemic control, however. We used structural equation modeling to examine a conceptual model that hypothesizes how self-efficacy, social support and patient-provider communication influence glycemic control through self-care behaviors in Chinese adults with type 2 diabetes.
Methods
We conducted a cross-sectional study of 222 Chinese adults with type 2 diabetes in one primary care center. We collected information on demographics, self-efficacy, social support, patient-provider communication (PPC) and diabetes self-care. Hemoglobin A1c (HbA1c) values were also obtained. Measured variable path analyses were used to determine the predicted pathways linking self-efficacy, social support and PPC to diabetes self-care and glycemic control.
Results
Diabetes self-care had a direct effect on glycemic control (β = −0.21, p = .007), No direct effect was observed for self-efficacy, social support or PPC on glycemic control. There were significant positive direct paths from self-efficacy (β = 0.32, p < .001), social support (β = 0.17, p = .009) and PPC (β = 0.14, p = .029) to diabetes self-care. All of them had an indirect effect on HbA1c (β =–0.06, β =–0.04, β =–0.03 respectively). Additionally, PPC was positively associated with social support (γ = 0.32, p < .001).
Conclusions
Having better provider-patient communication, having social support, and having higher self-efficacy was associated with performing diabetes self-care behaviors; and these behaviors were directly linked to glycemic control. So longitudinal studies are needed to explore the effect of self-efficacy, social support and PPC on changes in diabetes self-care behaviors and glycemic control.
doi:10.1186/1471-2296-14-66
PMCID: PMC3668988  PMID: 23705978
Self-efficacy; Social support; Patient-provider communication; Glycemic control

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