In The News

Renal Outcomes With Canagliflozin in Type 2 Diabetes From the CANVAS Program

June 21, 2018. The Canagliflozin Cardiovascular Assessment Study (CANVAS) Program included 2 multicenter, double-blind, randomized trials assessing the effects of canagliflozin, a sodium-glucose cotransporter-2 inhibitor, vs placebo on major adverse cardiovascular events. Participants (N=10,142) had type 2 diabetes (T2D) and were at high risk for cardiovascular events. In a prespecified exploratory analysis, the long-term effects of canagliflozin on adjudicated and sustained renal outcomes were evaluated.

Efficacy and Safety of Dulaglutide in Type 2 Diabetes and Chronic Kidney Disease

June 14, 2018. AWARD-7, a multicenter, 52-week, open-label, randomized trial compared the efficacy and safety of the glucagon-like peptide-1 receptor agonist dulaglutide (1.5 mg and 0.75 mg) vs insulin glargine, both in combination with insulin lispro. Patients (N=577) had type 2 diabetes and moderate-to-severe chronic kidney disease.

FDA Approves First Long-Term Implantable Continuous Glucose Monitor

June 21, 2018. The US Food and Drug Administration has approved the Eversense Continuous Glucose Monitor (CGM) System by Senseonics, which is the first long-term (up to 90 days) implantable CGM. The device is implanted subcutaneously in the patient’s upper arm under local anesthesia. Glucose data, stored in a HIPAA-compliant cloud, are transmitted to the user’s mobile phone via Bluetooth. The device is approved for patients aged 18 years and older with type 1 or type 2 diabetes and should be used in addition to fingerstick blood glucose monitoring.

The Relationship Between Hypoglycemia and Cardiovascular Outcomes in LEADER

June 14, 2018. In the cardiovascular (CV) outcomes trial, Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER), liraglutide significantly lowered both the risk of CV events and hypoglycemia compared with placebo. Patients (N=9,340) had type 2 diabetes, were at high risk for CV disease, and were followed for 3.5 to 5.0 years. This post hoc study analyzed the relationship between severe hypoglycemia and time to first major adverse cardiovascular event (MACE), CV death, non-CV death, or all-cause death.

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.