In The News

Omnipod Dash Insulin Management System Gets FDA Clearance

June 4, 2018. Insulet has received US Food and Drug Administration approval for its new Omnipod Dash insulin management system. The system consists of a tubeless, waterproof insulin pump (the Pod) that connects wirelessly to a handheld Personal Diabetes Manager (PDM), which controls the Pod. The PDM calculates the user’s insulin needs based on readings from the Contour Next One blood glucose meter. The system also features Omnipod Display and View applications, which allow users to access insulin therapy data via Bluetooth on their smartphones.

Relationship Between Rising A1C and Stroke Risk

May 17, 2018. A systematic review and meta-analysis of 29 observational cohort and nested case-control studies comprising 532,779 participants was conducted to assess the association between rising A1C levels and stroke risk. Participants were aged ≥18 years and had type 1 or type 2 diabetes or did not have diabetes. A1C ≥6.5% was associated with an increased risk of first-ever stroke (average hazard ratio [HR]: 2.15, 95% confidence interval [CI]: 1.76, 2.63) compared to A1C <5.7%. Results were not significant for A1C 5.7% to 6.5% (average HR: 1.19, 95% CI: 0.87, 1.62).

Characteristics of Patients With Type 2 Diabetes Associated With Severe Hypoglycemia

June 2018. To identify characteristics typical of patients with severe hypoglycemia, electronic medical records of 50,439 patients with type 2 diabetes receiving care from the Cleveland Clinic Health System were used to identify the severe hypoglycemia events from 2006 to 2015. A severe hypoglycemia event was defined as hypoglycemia requiring an emergency department visit or hospitalization. Between 2006 and 2015, the incidence of severe hypoglycemia increased from 0.12% to 0.31% (P=0.01).

A1C Variability Predicts All-Cause Mortality in Patients With Type 2 Diabetes

March 26, 2018. A total of 15,733 patients with type 2 diabetes (T2D) enrolled in the 2006-2008 Renal Insufficiency and Cardiovascular Events Italian multicenter study. A1C measures and vital status data from 8,252 of these patients were used to evaluate the relationship between A1C variability vs A1C average and all-cause mortality. A total of 3 to 5 A1C values were used to calculate A1C-MEAN (average) and measures of A1C variability (intra-individual standard deviation [A1C-SD], SD adjusted for number of A1C assessments [A1C-AdjSD], and coefficient of variation [A1C-CV]).

Review of Diabetes Self-Management Mobile Applications

May 8, 2018. Users of mobile applications (apps) for diabetes self-management need better information regarding which apps actually improve diabetes-related outcomes. To help clarify this issue, the Agency for Healthcare Research and Quality (AHRQ) conducted a rapid evidence review of 15 studies evaluating diabetes apps. Of the hundreds of commercially available apps, the AHRQ found that only 11 (6 for type 1 diabetes and 5 for type 2 diabetes) have been researched, and that in all cases these studies lasted <1 year.

Glucagon-like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter-2 Inhibitors Associated With Better Mortality Than Dipeptidyl Peptidase 4 Inhibitors

April 17, 2018. A network meta-analysis compared the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter-2 (SGLT-2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors to reduce all-cause mortality in people with type 2 diabetes (T2D). Included in the meta-analysis were 236 trials with a total of 176,310 participants.

Changes in A1C and Body Weight by Subgroup in Patients With Type 2 Diabetes in DURATION-8

April 19, 2018. DURATION-8 (Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention With Exenatide Once Weekly) was a double-blind, phase 3, randomized controlled trial conducted in patients with type 2 diabetes (N=694). The trial assessed the efficacy at 28 weeks of the glucagon-like peptide-1 (GLP-1) receptor agonist exenatide plus the sodium-glucose cotransporter-2 (SGLT-2) dapagliflozin vs dapagliflozin alone or exenatide alone, all with background metformin therapy.

Dulaglutide Added to Sodium-Glucose Cotransporter-2 Inhibitors Improves Glycemic Control in Patients with Type 2 Diabetes

February 23, 2018. This double-blind, parallel-arm, placebo-controlled, phase 3b study assessed the superiority of the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide vs placebo when added to a sodium-glucose cotransporter-2 (SLGT-2) inhibitor. Patients (N=424) with uncontrolled type 2 diabetes (T2D) were randomized to receive dulaglutide 1.5 mg, dulaglutide 0.75 mg, or placebo, with or without metformin.

FDA Approves Bydureon Add-On Therapy for Adults With Type 2 Diabetes

April 3, 2018. The US Food and Drug Administration has approved the use of Bydureon—extended-release exenatide—as add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with poor glycemic control. This expanded indication is based on data from the DURATION-7 study, which evaluated Bydureon vs placebo as add-on therapy to insulin glargine in patients with T2D. In this study, mean A1C was reduced by 0.9% in the Bydureon group compared with 0.2% in the placebo group; similar rates of hypoglycemia were reported for both groups.

FDA Committee Recommends Approval of Continuous Glucose Monitor That Can Be Implanted for 3 Months

March 29, 2018. A US Food and Drug Administration advisory committee has voted unanimously to recommend approval of a continuous glucose monitor (CGM) that can be worn for up to 90 days. The device, the Eversense CGM, is manufactured by Senseonics. It is a small, fluorescence-based glucose sensor that can be implanted in the patient’s upper arm and paired with a transmitter to provide real-time data using a smartphone app.