Effects of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes: design of the IN CONTROL-trial

<p>Abstract</p> <p>Background</p> <p>Diabetes specific emotional problems interfere with the demanding daily management of living with type 2 diabetes mellitus (T2DM). Possibly, offering direct feedback on diabetes management may diminish the presence of diabetes specific emotional problems and might enhance the patients' belief they are able to manage their illness. It is hypothesized that self-monitoring of glucose in combination with an algorithm how and when to act will motivate T2DM patients to become more active participants in their own care leading to a decrease in diabetes related distress and an increased self-efficacy.</p> <p>Methods and design</p> <p>Six hundred patients with T2DM (45 ≤ 75 years) who receive care in a structured diabetes care system, HbA1c ≥ 7.0%, and not using insulin will be recruited and randomized into 3 groups; Self-monitoring of Blood Glucose (SMBG), Self-monitoring of Urine Glucose (SMUG) and usual care (n = 200 per group). Participants are eligible if they have a known disease duration of over 1 year and have used SMBG or SMUG less than 3 times in the previous year. All 3 groups will receive standardized diabetes care. The intervention groups will receive additional instructions on how to perform self-monitoring of glucose and how to interpret the results. Main outcome measures are changes in diabetes specific emotional distress and self-efficacy. Secondary outcome measures include difference in HbA1c, patient satisfaction, occurrence of hypoglycaemia, physical activity, costs of direct and indirect healthcare and changes in illness beliefs.</p> <p>Discussion</p> <p>The IN CONTROL-trial is designed to explore whether feedback from self-monitoring of glucose in T2DM patients who do not require insulin can affect diabetes specific emotional distress and increase self-efficacy. Based on the self-regulation model it is hypothesized that glucose self-monitoring feedback changes illness perceptions, guiding the patient to reduce emotional responses to experienced threats, and influences the patients ability to perform and maintain self-management skills.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN84568563</p

What are the basic self-monitoring components for cardiovascular risk management?

<p>Abstract</p> <p>Background</p> <p>Self-monitoring is increasingly recommended as a method of managing cardiovascular disease. However, the design, implementation and reproducibility of the self-monitoring interventions appear to vary considerably. We examined the interventions included in systematic reviews of self-monitoring for four clinical problems that increase cardiovascular disease risk.</p> <p>Methods</p> <p>We searched Medline and Cochrane databases for systematic reviews of self-monitoring for: heart failure, oral anticoagulation therapy, hypertension and type 2 diabetes. We extracted data using a pre-specified template for the identifiable components of the interventions for each disease. Data was also extracted on the theoretical basis of the education provided, the rationale given for the self-monitoring regime adopted and the compliance with the self-monitoring regime by the patients.</p> <p>Results</p> <p>From 52 randomized controlled trials (10,388 patients) we identified four main components in self-monitoring interventions: education, self-measurement, adjustment/adherence and contact with health professionals. Considerable variation in these components occurred across trials and conditions, and often components were poorly described. Few trials gave evidence-based rationales for the components included and self-measurement regimes adopted.</p> <p>Conclusions</p> <p>The components of self-monitoring interventions are not well defined despite current guidelines for self-monitoring in cardiovascular disease management. Few trials gave evidence-based rationales for the components included and self-measurement regimes adopted. We propose a checklist of factors to be considered in the design of self-monitoring interventions which may aid in the provision of an evidence-based rationale for each component as well as increase the reproducibility of effective interventions for clinicians and researchers.</p

Does Availability of AIR Insulin Increase Insulin Use and Improve Glycemic Control in Patients with Type 2 Diabetes?

Background: In the concordance model, physician and patient discuss treatment options, explore the impact of treatment decisions from the patient's perspective, and make treatment choices together. We tested, in a concordance setting, whether the availability of AIR (R) inhaled insulin (developed by Alkermes, Inc. [Cambridge, MA] and Eli Lilly and Company [Indianapolis, IN]; AIR is a registered trademark of Alkermes, Inc.), as compared with existing treatment options alone, leads to greater initiation and maintenance of insulin therapy and improves glycemic control in patients with type 2 diabetes.Methods: This was a 9-month, multicenter, parallel, open- label study in adult, nonsmoking patients with diabetes not optimally controlled by two or more oral antihyperglycemic medications. Patients were randomized to the Standard Options group (n = 516), in which patients chose a regimen from drugs in each major treatment class excluding inhaled insulin, or the Standard Options + AIR insulin group (n = 505), in which patients had the same choices plus AIR insulin. The primary end points were the proportion of patients in each group using insulin at end point and change in hemoglobin A1C (A1C) from baseline to end point.Results: At end point, 53% of patients in the Standard Options group and 59% in the Standard Options + AIR insulin group were using insulin (P = 0.07). Both groups reduced A1C by about 1.2% and reported increased well-being and treatment satisfaction. The most common adverse event with AIR insulin was transient cough.Conclusions: The opportunity to choose AIR insulin did not affect overall use of insulin at end point or A1C outcomes. Regardless of group assignment, utilizing a shared decision-making approach to treatment choices (concordance model), resulted in improved treatment satisfaction and A1C values at end point. Therefore, increasing patient involvement in treatment decisions may improve outcomes

Chronic CNS oxytocin signaling preferentially induces fat loss in high-fat diet-fed rats by enhancing satiety responses and increasing lipid utilization

Based largely on a number of short-term administration studies, growing evidence suggests that central oxytocin is important in the regulation of energy balance. The goal of the current work is to determine whether long-term third ventricular (3V) infusion of oxytocin into the central nervous system (CNS) is effective for obesity prevention and/or treatment in rat models. We found that chronic 3V oxytocin infusion between 21 and 26 days by osmotic minipumps both reduced weight gain associated with the progression of high-fat diet (HFD)-induced obesity and elicited a sustained reduction of fat mass with no decrease of lean mass in rats with established diet-induced obesity. We further demonstrated that these chronic oxytocin effects result from 1) maintenance of energy expenditure at preintervention levels despite ongoing weight loss, 2) a reduction in respiratory quotient, consistent with increased fat oxidation, and 3) an enhanced satiety response to cholecystokinin-8 and associated decrease of meal size. These weight-reducing effects persisted for approximately 10 days after termination of 3V oxytocin administration and occurred independently of whether sucrose was added to the HFD. We conclude that long-term 3V administration of oxytocin to rats can both prevent and treat diet-induced obesity