Background

Left ventricular dysfunction and the development of heart failure is a frequent and serious complication of myocardial infarction. Recent animal experimental studies suggested that metformin treatment reduces myocardial injury and preserves cardiac function in non-diabetic rats after experimental myocardial infarction. We will study the efficacy of metformin with the aim to preserve left ventricular ejection fraction in non-diabetic patients presenting with ST elevation myocardial infarction (STEMI).

Methods

The Glycometabolic Intervention as adjunct to Primary percutaneous intervention in ST elevation myocardial infarction (GIPS)-III trial is a prospective, single center, double blind, randomized, placebo-controlled trial. Three-hundred-and-fifty patients, without diabetes, requiring primary percutaneous coronary intervention (PCI) for STEMI will be randomized to metformin 500 mg twice daily or placebo treatment and will undergo magnetic resonance imaging (MRI) after 4 months. Major exclusion criteria were prior myocardial infarction and severe renal dysfunction. The primary efficacy parameter is left ventricular ejection fraction 4 months after randomization. Secondary and tertiary efficacy parameters include major adverse cardiac events, new onset diabetes and glycometabolic parameters, and echocardiographic diastolic function. Safety parameters include renal function deterioration and lactic acidosis.

Conclusions

The GIPS-III trial will evaluate the efficacy of metformin treatment to preserve left ventricular ejection fraction in STEMI patients without diabetes.

Background

Comorbidity is often mentioned as interfering with “optimal” treatment decisions in diabetes care. It is suggested that diabetes-related comorbidity will increase adequate treatment, whereas diabetes-unrelated comorbidity may decrease this process of care. We hypothesized that these effects differ according to expected priority of the conditions.

Methods

We evaluated the relationship between comorbidity and treatment intensification in a study of 11,248 type 2 diabetes patients using the GIANTT (Groningen Initiative to Analyse type 2 diabetes Treatment) database. We formed a cohort of patients with a systolic blood pressure ≥140 mmHg (6,820 hypertensive diabetics), and a cohort of patients with an HbA1c ≥7% (3,589 hyperglycemic diabetics) in 2007. We differentiated comorbidity by diabetes-related or unrelated conditions and by priority. High priority conditions include conditions that are life-interfering, incident or requiring new medication treatment. We performed Cox regression analyses to assess association with treatment intensification, defined as dose increase, start, or addition of drugs.

Results

In both the hypertensive and hyperglycemic cohort, only patients with incident diabetes-related comorbidity had a higher chance of treatment intensification (HR 4.48, 2.33–8.62 (p<0.001) for hypertensives; HR 2.37, 1.09–5.17 (p = 0.030) for hyperglycemics). Intensification of hypertension treatment was less likely when a new glucose-regulating drug was prescribed (HR 0.24, 0.06–0.97 (p = 0.046)). None of the prevalent or unrelated comorbidity was significantly associated with treatment intensification.

Conclusions

Diabetes-related comorbidity induced better risk factor treatment only for incident cases, implying that appropriate care is provided more often when complications occur. Diabetes-unrelated comorbidity did not affect hypertension or hyperglycemia management, even when it was incident or life-interfering. Thus, the observed “undertreatment” in diabetes care cannot be explained by constraints caused by such comorbidity.

OBJECTIVE

This study compared the durability of glycemic control of twice-daily insulin lispro mix 75/25 (LM75/25: 75% insulin lispro protamine suspension/25% lispro) and once-daily insulin glargine, added to oral antihyperglycemic drugs in type 2 diabetes patients.

RESEARCH DESIGN AND METHODS

During the initiation phase, patients were randomized to LM75/25 or glargine. After 6 months, patients with A1C ≤7.0% advanced to the maintenance phase for ≤24 months. The primary objective was the between-group comparison of duration of maintaining the A1C goal.

RESULTS

Of 900 patients receiving LM75/25 and 918 patients receiving glargine who completed initiation, 473 and 419, respectively, had A1C ≤7.0% and continued into maintenance. Baseline characteristics except age were similar in this group. Median time of maintaining the A1C goal was 16.8 months for LM75/25 (95% CI 14.0–19.7) and 14.4 months for glargine (95% CI 13.4–16.8; P = 0.040). A1C goal was maintained in 202 LM75/25-treated patients (43%) and in 147 glargine-treated patients (35%; P = 0.006). No differences were observed in overall, nocturnal, or severe hypoglycemia. LM75/25 patients had higher total daily insulin dose (0.45 ± 0.21 vs. 0.37 ± 0.21 units/kg/day) and more weight gain (5.4 ± 5.8 vs. 3.7 ± 5.6 kg) from baseline. Patients taking LM75/25 and glargine with lower baseline A1C levels were more likely to maintain the A1C goal (P = 0.043 and P < 0.001, respectively).

CONCLUSIONS

A modestly longer durability of glycemic control was achieved with LM75/25 compared with glargine. Patients with lower baseline A1C levels were more likely to maintain the goal, supporting the concept of earlier insulin initiation.

Abstract

Objective

This study determined the influence of needle length for insulin administration on metabolic control and patient preference in obese patients with diabetes mellitus.

Methods

In this multicenter, open-label crossover study, insulin pen needles of two different lengths (5 mm and 8 mm) were compared. A total of 130 insulin-treated type 1 and type 2 diabetes patients with a body mass index ≥30 kg/m2 were randomized, and 126 patients completed the study. Patients started using the 5-mm needle for 3 months, after which they switched to injecting insulin with the 8-mm needle for another 3 months, or vice versa. Hemoglobin A1c (A1C), fructosamine, and 1,5-anhydroglucitol were measured, and self-reported side effects and patient preference were recorded.

Results

No within-group changes were observed with respect to A1C, serum fructosamine, 1,5-anhydroglucitol, hypoglycemic events, bruising, and pain. When data of all 126 subjects were pooled, there was a small, but significant, difference between needle lengths (5-mm, A1C 7.47 ± 0.9%; 8-mm, 7.59 ± 1.0%; P = 0.02). Patients reported less bleeding with the 5-mm needle (P = 0.04) and less insulin leakage from the skin with the 8-mm needle (P = 0.01). There were no significant differences in patient preference, with 46% of the patients preferring the 5-mm needle, 41% the 8-mm needle, and 13% not preferring a particular needle length.

Conclusions

A 5-mm needle is similar to an 8-mm needle in obese patients with diabetes with respect to metabolic control, injection-related complaints, or patient preference and can be used safely.

OBJECTIVE

To compare the ability of two starter insulin regimens to achieve glycemic control in a large, ethnically diverse population with type 2 diabetes.

RESEARCH DESIGN AND METHODS

During the initiation phase of the DURABLE trial, patients were randomized to a twice-daily lispro mix 75/25 (LM75/25; 75% lispro protamine suspension, 25% lispro) (n = 1,045) or daily glargine (GL) (n = 1,046) with continuation of prestudy oral antihyperglycemic drugs.

RESULTS

Baseline A1C was similar (LM75/25: 9.1 ± 1.3%; GL: 9.0 ± 1.2%; P = 0.414). At 24 weeks, LM75/25 patients had lower A1C than GL patients (7.2 ± 1.1 vs. 7.3 ± 1.1%, P = 0.005), greater A1C reduction (–1.8 ± 1.3 vs. –1.7 ± 1.3%, P = 0.005), and higher percentage reaching A1C target <7.0% (47.5 vs. 40.3%, P < 0.001). LM75/25 was associated with higher insulin dose (0.47 ± 0.23 vs. 0.40 ± 0.23 units · kg−1· day−1, P < 0.001) and more weight gain (3.6 ± 4.0 vs. 2.5 ± 4.0 kg, P < 0.0001). LM75/25 patients had a higher overall hypoglycemia rate than GL patients (28.0 ± 41.6 vs. 23.1 ± 40.7 episodes · pt−1· year−1, P = 0.007) but lower nocturnal hypoglycemia rate (8.9 ± 19.3 vs. 11.4 ± 25.3 episodes · pt−1· year−1, P = 0.009). Severe hypoglycemia rates were low in both groups (LM75/25: 0.10 ± 1.6 vs. GL: 0.03 ± 0.3 episodes · pt−1· year−1, P = 0.167).

CONCLUSIONS

Compared with GL, LM75/25 resulted in slightly lower A1C at 24 weeks and a moderately higher percentage reaching A1C target <7.0%. Patients receiving LM75/25 experienced more weight gain and higher rates of overall hypoglycemia but lower rates of nocturnal hypoglycemia. Durability of regimens will be evaluated in the following 2-year maintenance phase.

Background

The purpose of this prospective study was to evaluate the clinical diagnostic value of iodine-124 (124I)-positron emission tomography (PET) in patients with advanced differentiated thyroid carcinoma (DTC) and to compare the 124I-PET imaging results with the 131I whole-body scan (WBS).

Materials and methods

Twenty patients with histologically proven advanced DTC (including T4, extra-nodal tumour growth, or distant metastases) underwent diagnostic 131I-WBS, 124I-PET scan, and post-treatment 131I-WBS 4 months after ablation. The findings on the 124I-PET were compared with the findings on the diagnostic and post-therapeutic 131I-WBS and were also correlated with radiologic and/or cytological investigations.

Results

124I-PET vs diagnostic 131I-WBS. Eleven patients showed uptake on the 124I-PET. Only 3 of these 11 patients also showed uptake on the diagnostic 131I scan, but the uptake was more clearly visible and the abnormalities were more extensive on the 124I-PET. 124I-PET vs post-treatment 131I-WBS. Eleven patients showed uptake on the 124I-PET, which was also visible on the post-treatment scan in nine patients; in the other two patients, no uptake was observed on the post-treatment scan and no anatomical localisation could be confirmed. Two patients showed only uptake on the post-treatment scan without uptake on the 124I-PET: in one, the uptake was confirmed by MRI, and in the other, no anatomical localisation was found. In seven patients, no uptake was observed on both the scans.

Conclusion

124I-PET proved to be a superior diagnostic tool as compared to low-dose diagnostic 131I scans and adequately predicted findings on subsequent high-dose post-treatment 131I scans.

Sensitivity of thyroglobulin (Tg) measurement in the follow-up of differentiated thyroid carcinoma (DTC) can be optimized by using a sensitive Tg assay and rhTSH stimulation. We evaluated the diagnostic yield of a sensitive Tg assay and rhTSH stimulated Tg in the detection of recurrences in the follow-up of DTC. Additionally the value of imaging techniques for the localization of recurrences was evaluated. We included 121 disease free patients in long-term follow-up for DTC (median 10 years, range 1–34). Tg during thyroid hormone suppression therapy (Tg-on) and rhTSH stimulated Tg were measured with a sensitive Tg assay. Patients with rhTSH stimulated Tg ≥1.0 ng/ml underwent imaging with neck ultrasound, FDG-PET and post therapy 131I WBS. Sensitive Tg measurement resulted in 3 patients with Tg-on ≥1.0 ng/ml, recurrence could be localized in 2 of them. RhTSH stimulation resulted in Tg ≥1.0 ng/ml in another 17 of 118 patients. Recurrence could be localized in only 1 additional patient (1 out of 118 patients). Recurrence was localized by neck ultrasound in 1 of 3, by FDG-PET in 2 of 3 and by post therapy 131I WBS in 2 of 3 patients. In the detection of recurrences in DTC, rhTSH stimulation had very limited additional value in comparison to Tg-on measurement with a sensitive Tg assay. We consider this too low to justify rhTSH stimulation in all patients during long-term follow up. Neck ultrasound, FDG-PET and post therapy 131I WBS showed complementary value in localization of disease, but were only positive in a small fracture of all procedures.

Abstract

Background

In order to improve the quality of care of chronically ill patients the traditional boundaries between primary and secondary care are questioned. To demolish these boundaries so-called ‘shared care’ projects have been initiated in which different ways of substitution of care are applied. When these projects end, disease management may offer a solution to expand the achieved co-operation between primary and secondary care.

Objective

Answering the question: What key factors influence the development and implementation of shared care projects from a management perspective and how are they linked?

Theory

The theoretical framework is based on the concept of the learning organisation.

Design

Reference point is a multiple case study that finally becomes a single case study. Data are collected by means of triangulation. The studied cases concern two interrelated Dutch shared care projects for type 2 diabetic patients, that in the end proceed as one disease management project.

Results

In these cases the predominant key-influencing factors appear to be the project management, commitment and local context, respectively. The factor project management directly links the latter two, albeit managing both appear prerequisites to its success. In practice this implies managing the factors' interdependency by the application of change strategies and tactics in a committed and skilful way.

Conclusion

Project management, as the most important and active key factor, is advised to cope with the interrelationships of the influencing factors in a gradually more fundamental way by using strategies and tactics that enable learning processes. Then small-scale shared care projects may change into a disease management network at a large scale, which may yield the future blueprint to proceed.