Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study.

BACKGROUND: The objective of the study was to evaluate the clinical effectiveness and safety of a device that combines an insulin pump with real-time continuous glucose monitoring (CGM), compared to using an insulin pump with standard blood glucose monitoring systems. METHODS: This 6-month, randomized, multicenter, treat-to-target study enrolled 146 subjects treated with continuous subcutaneous insulin infusion between the ages of 12 and 72 years with type 1 diabetes and initial A1C levels of >or=7.5%. Subjects were randomized to pump therapy with real-time CGM (sensor group [SG]) or to pump therapy and self-monitoring of blood glucose only (control group [CG]). Clinical effectiveness and safety were evaluated. RESULTS: A1C levels decreased (P<0.001) from baseline (8.44+/-0.70%) in both groups (SG, -0.71+/-0.71%; CG, -0.56+/-0.072%); however, between-group differences did not achieve significance. SG subjects showed no change in mean hypoglycemia area under the curve (AUC), whereas CG subjects showed an increase (P=0.001) in hypoglycemia AUC during the blinded periods of the study. The between-group difference in hypoglycemia AUC was significant (P<0.0002). Greater than 60% sensor utilization was associated with A1C reduction (P=0.0456). Fourteen severe hypoglycemic events occurred (11 in the SG group and three in the CG group, P=0.04). CONCLUSIONS: A1C reduction was no different between the two groups. Subjects in the CG group had increased hypoglycemia AUC and number of events during blinded CGM use; however, there was no increase in hypoglycemia AUC or number of events in the SG group. Subjects with greater sensor utilization showed a greater improvement in A1C levels.

The impact of insulin glargine on clinical and humanistic outcomes in patients uncontrolled on other insulin and oral agents: an office-based naturalistic study.

OBJECTIVE: Controlling blood glucose levels in patients with diabetes often requires aggressive treatment, which may in turn cause hypoglycemia and/or decreased health-related quality of life (HRQOL). Insulin glargine, a long-acting insulin, has shown benefits of decreased nocturnal hypoglycemia without significant weight gain, while providing good glycemic control in clinical trials. These benefits have often been reported in studies of less than 1 year duration. The objective of this study was to evaluate the effectiveness of insulin glargine over a 12-month period in a clinical practice setting, and measure its effects on HRQOL in a subset of patients. DESIGN AND METHODS: Patients with diabetes in a large private endocrinology practice were initiated on insulin glargine. Patients were divided into 2 cohorts: the first group included patients with type 1 diabetes (T1D, n = 135); the second group included patients with type 2 diabetes previously on insulin and/or oral agents (T2D, n = 180). The HRQOL subset analysis included 50 patients from the above study. Patients completed a 40-item questionnaire adapted from the Diabetes Symptom Checklist-Revised (DSC-R) and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) at weeks 0, 2, 6, 12, and 16. RESULTS: Patients in both cohorts experienced statistically significant decreases in mean ( +/- SD) A1C: group T1D, -0.28 +/- 1.47 (P = 0.0307); group T2D, -0.60 +/- 1.51 (P < 0.0001), with no significant changes in body mass index. In the year following insulin glargine therapy, there were significantly fewer hypoglycemic events per patient than in the year prior to insulin glargine therapy (group T1D: -0.33, P = 0.002; group T2D: -0.20, P = 0.004). HRQOL subset analysis also revealed a significant decrease in A1C (P < 0.0001) after 16 weeks of therapy with insulin glargine. In this subset of patients, there was a significant improvement in overall well being (P = 0.0019), emotional well being (P = 0.003), total symptom scores (P < 0.0001), and total symptom distress (P < 0.0001). The limitations of the study are those inherently associated with naturalistic observational studies such as recall bias and compliance. CONCLUSIONS: Insulin glargine use over a 12-month period in a clinical practice setting was shown to significantly improve A1C without adversely impacting weight or the occurrence of hypoglycemia. Significant improvements were also observed in HRQOL.

United States patient preference and usability for the new disposable insulin device Solostar versus other disposable pens.

The uptake of insulin pen use has been slow in the United States, despite their advantages over the vial/ syringe. We present results of a United States subset of 150 patients with type 1/type 2 diabetes, who were enrolled in an open-label study, that assessed usability, pen features, and patient preferences for four prefilled insulin pens: SoloSTAR, FlexPen, Lilly disposable pen, and a prototype, Pen X. Overall, the SoloSTAR and FlexPen were more user-friendly; 95 and 88% of patients, respectively, completed the steps correctly (without safety/attach-needle step-deemed independent of device) versus the Lilly disposable pen (60%) and Pen X (61%; all p < 0.05). The SoloSTAR was rated highest most frequently for pen feature comparisons. Results suggest that the SoloSTAR and FlexPen could potentially facilitate insulin use in the United States.