Diabetes management intervention studies: lessons learned from two studies.

Introduction: Several clinical studies investigated improvements of patient outcomes due to diabetes management interventions. However, chronic disease management is intricate with complex multifactorial behavior patterns. Such studies thus have to be well designed in order to allocate all observed effects to the defined intervention and to exclude effects of other confounders as well as possible.

A novel approach for obtaining 12-lead electrocardiograms in horses.

Background: In equine medicine, 12-lead electrocardiograms (ECGs) rarely are used, which may in part be a result of shortcomings in the existing guidelines for obtaining 12-lead ECGs in horses. The guidelines recommend placing the limb leads on the extremities, which is inappropriate because the ventricular mean electrical axis is then perpendicular to the limb leads, leading to large variations in ECG configuration even among healthy horses. From an electrophysiological point of view, the leads instead should be parallel to the electrical axis to minimize variability.

Open Source Closed-Loop Insulin Delivery Systems: A Clash of Cultures or Merging of Diverse Approaches?

Biomedical outcomes for people with diabetes remain suboptimal for many. Psychosocial care in diabetes does not fare any better. "Artificial pancreas" (also known as "closed-loop" and "automated insulin delivery") systems present a promising therapeutic option for people with diabetes (PWD)-simultaneously improving glycemic outcomes, reducing the burden of self-management, and improving health-related quality of life.

Use of a Novel, Remotely Connected Diabetes Management System Is Associated with Increased Treatment Satisfaction, Reduced Diabetes Distress, and Improved Glycemic Control in Individuals with Insulin-Treated Diabetes: First Results from the Personal Diabetes Management Study.

Background: The ability to automatically transfer data to clinicians and receive timely guidance in therapy adjustments through remote and in-office consults can positively impact patients' perceptions about quality of care, which is positively associated with clinical outcomes. We assessed the impact of using the Accu-Chek Connect diabetes management system on treatment satisfaction, diabetes distress, and glycemic control in adults with type 1 diabetes and insulin-treated type 2 diabetes.

Subjects And Methods: This 6-month, prospective, multicenter, single-arm study assessed the impact of using the system on treatment satisfaction and glycemic control among 87 adults with insulin-treated diabetes (multiple daily insulin injections and basal only), with 8.

Randomized Cross-Over Study Comparing Two Infusion Sets for CSII in Daily Life.

Background: Continuous subcutaneous insulin infusion (CSII) therapy is a valuable option especially for people with type 1 diabetes. Although insulin infusion sets (IIS) are essential components of most insulin pump systems, only few studies have been conducted on their performance and safety. In this study 2 IIS with soft cannulas were compared.

Frequent use of an automated bolus advisor improves glycemic control in pediatric patients treated with insulin pump therapy: results of the Bolus Advisor Benefit Evaluation (BABE) study.

Background: The relationship between frequency and sustained bolus advisor (BA) use and glycemic improvement has not been well characterized in pediatric populations.

Objective: The objective of this study is to assess the impact of frequent and persistent BA use on glycemic control among pediatric type 1 diabetes patients.

Methods: In this 6-month, single-center, retrospective cohort study, 104 children [61 girls, mean age: 12.

Use of an insulin bolus advisor facilitates earlier and more frequent changes in insulin therapy parameters in suboptimally controlled patients with diabetes treated with multiple daily insulin injection therapy: results of the ABACUS trial.

Background: We assessed the impact of using an automated bolus advisor integrated into a blood glucose meter on the timing and frequency of adjusting insulin therapy parameter settings and whether the availability of this technology would increase blood glucose test strip utilization in diabetes patients treated with multiple daily insulin injection (MDI) therapy.

Subjects And Methods: The Automated Bolus Advisor Control and Usability Study (ABACUS) trial, a 26-week, prospective, randomized, controlled, multinational study that enrolled 218 type 1 and type 2 diabetes patients, demonstrated that use of an automated insulin bolus advisor helps improve glycemic control in suboptimally controlled, MDI-treated patients. Patient data were assessed to determine when and how often changes in insulin parameter settings occurred during the study.

Use of an insulin bolus advisor improves glycemic control in multiple daily insulin injection (MDI) therapy patients with suboptimal glycemic control: first results from the ABACUS trial.

Objective: Use of automated bolus advisors is associated with improved glycemic control in patients treated with insulin pump therapy. We conducted a study to assess the impact of using an insulin bolus advisor embedded in a blood glucose (BG) meter on glycemic control and treatment satisfaction in patients treated with multiple daily insulin injection (MDI) therapy. The study goal was to achieve >0.

Automated bolus advisor control and usability study (ABACUS): does use of an insulin bolus advisor improve glycaemic control in patients failing multiple daily insulin injection (MDI) therapy? [NCT01460446].

Background: People with T1DM and insulin-treated T2DM often do not follow and/or adjust their insulin regimens as needed. Key contributors to treatment non-adherence are fear of hypoglycaemia, difficulty and lack of self-efficacy associated with insulin dose determination. Because manual calculation of insulin boluses is both complex and time consuming, people may rely on empirical estimates, which can result in persistent hypoglycaemia and/or hyperglycaemia.

The impact of structured blood glucose testing on attitudes toward self-management among poorly controlled, insulin-naïve patients with type 2 diabetes.

Introduction: Patients with T2DM often view self-monitoring of blood glucose (SMBG) as burdensome and pointless, which may affect their broader attitudes toward diabetes management. We examined how a structured SMBG protocol influenced diabetes self-efficacy and autonomous motivation over time, and linked these to changes in glycemic control.

Materials And Methods: The Structured Testing Program (STeP) is a 12-month, two-arm, cluster-randomized trial that assessed the efficacy of structured SMBG in 483 insulin-naïve T2DM patients.

A structured self-monitoring of blood glucose approach in type 2 diabetes encourages more frequent, intensive, and effective physician interventions: results from the STeP study.

Background: We evaluated how a structured patient/physician self-monitoring of blood glucose (SMBG) intervention influenced the timing, frequency, and effectiveness of primary care physicians' treatment changes with type 2 diabetes mellitus (T2DM) patients over 12 months.

Methods: The Structured Testing Program (STeP) study was a cluster-randomized, multicenter trial with 483 poorly controlled, insulin-naive T2DM subjects. Primary care practices were randomized to the Active Control Group (ACG) or the Structured Testing Group (STG), the latter of which included quarterly review of structured SMBG results.

Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study.

Objective: To assess the effectiveness of structured blood glucose testing in poorly controlled, noninsulin-treated type 2 diabetes.

Research Design And Methods: This 12-month, prospective, cluster-randomized, multicenter study recruited 483 poorly controlled (A1C ≥ 7.5%), insulin-naïve type 2 diabetic subjects from 34 primary care practices in the U.

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.

Comparison of continuous blood glucose measurement with conventional documentation of hypoglycemia in patients with Type 2 diabetes on multiple daily insulin injection therapy.

Background: The primary objective of this study was to investigate the difference in the proportion of patients with conventionally detected hypoglycemia compared with continuous glucose monitoring system (CGMS, Medtronic MiniMed, Sylmar, CA)-detected glucose values < or = 60 mg/dL (< or = 3.3 mmol/L), during the 72-h CGMS measurement period after 8 weeks' treatment with insulin glargine.

Methods: This was a multicenter (n = 125), open-label, single-arm study in patients with Type 2 diabetes mellitus (T2DM) on multiple daily injections.