In The News

The Impact of Nocturnal Hypoglycemia on Sleep in Subjects With Type 2 Diabetes

September 25, 2015. This single-blind crossover trial evaluated the impact of nocturnal hypoglycemia on sleep patterns and counterregulatory hormones in 26 patients with type 2 diabetes (T2D). Patients attended 2 nighttime sleep studies—1 normoglycemic and 1 hypoglycemic. Patient glucose levels were controlled during sleep using hyperinsulinemic glucose clamping. On the hypoglycemic night, the plasma glucose infusion was turned off until glucose levels ranged from 48.6 mg/dL to 50.4 mg/dL for 15 minutes. Patients were subsequently returned to normoglycemia.

Diabetes Care in the School Setting: A Position Statement of the American Diabetes Association

October 2015. The American Diabetes Association has released an updated position statement on diabetes care in school settings. The purpose of this statement is to provide school staff and other key stakeholders with diabetes management recommendations for students with diabetes in elementary and secondary school settings. The document addresses key legal issues and provides guidelines for diabetes care in school settings. You can download the full document at this link.

FDA Approves 2 Insulin Treatments for Diabetes Mellitus

September 25, 2015. The US Food and Drug Administration has approved 2 new insulins for the reduction of blood glucose levels in patients with diabetes mellitus: Tresiba (insulin degludec, a long-acting insulin), and Ryzodeg 70/30 (insulin degludec/insulin aspart, a combination of long-acting and rapid-acting insulins). You can follow this link to read the full FDA press release, which provides details of the clinical trials conducted to evaluate these insulins.

Empagliflozin Reduces Cardiovascular Outcomes in Patients With Type 2 Diabetes

September 17, 2015. A long-term randomized, controlled trial shows decreased risk of cardiovascular (CV) events and all-cause mortality associated with the use of empagliflozin in patients with type 2 diabetes (T2D). A total of 7020 patients received 10 mg or 25 mg of empagliflozin or placebo, once daily, over a median observation period of 3.1 years. Compared to the placebo group, patients who received empagliflozin at any dosage experienced decreased risk for CV events.

Randomized Trial Shows Improved Blood Glucose With Artificial Beta Cell Compared to Insulin Pump Treatment

September 18, 2015. Results from 2 randomized controlled trials presented at the European Association for the Study of Diabetes (EASD) indicate improved blood glucose control with a “closed-loop” insulin delivery system, compared with standard sensor-augmented pump therapy. The closed-loop system, also called an “artificial beta cell,” monitors and automatically responds to blood glucose levels, adjusting insulin to follow a programmed algorithm.

New Study Suggests That Incretin Drugs Do Not Cause Pancreatic Cancer

September 15, 2015. The results of a 7-year Danish nationwide case-control study evaluating the risk of pancreatic cancer associated with the use of incretin-based drugs compared with other glucose-lowering therapies were presented at the European Association for the Study of Diabetes (EASD) 2015 meeting. Overall, investigators found that diabetes itself is a risk factor for pancreatic cancer, independent of any specific drug effect.

FDA Drug Safety Communication for Canagliflozin: New Information on Bone Fracture Risk and Decreased Bone Mineral Density

September 10, 2015. The US Food and Drug Administration (FDA) has strengthened the drug label warning for the type 2 diabetes medicine canagliflozin (trade names: Invokana, Invokamet). This warning is related to the increased risk of bone fractures and decreased bone mineral density associated with canagliflozin use. Specifically, the FDA has added a new “Warning and Precaution” and has revised the “Adverse Reactions” section of canagliflozin prescribing information.

Diabetes Screening Impact of Lowering BMI Cut Points for Asian Americans

August 31, 2015. The 2015 American Diabetes Association Standards of Medical Care in Diabetes has established a new body mass index (BMI) cut point for diabetes screening in Asian Americans of 23k/m2. This study applied 2011/2012 data from the National Health and Nutrition Examination Survey to estimate the prevalence of prediabetes and diabetes in Asian Americans using this lower cut point.

FDA Announces Voluntary Recall of OmniPod (Pod) Insulin Management System by Insulet Corporation

August 28, 2015. The US Food and Drug Administration (FDA) has announced a voluntary recall of 40,846 boxes of the OmniPod (Pod) Insulin Management System, manufactured by the Insulet Corporation. This corrective action is due to the possibility that some Pods from these lots may have a higher failure rate than Insulet's current manufacturing standards. There are 2 ways in which these Pods may fail: 1) the cannula may either completely retract or fail to fully deploy; or 2) the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced.

Severe Diabetic Ketoacidosis in the Canagliflozin Type 2 Diabetes Clinical Program

September 2015. This study evaluated the incidence of serious diabetic ketoacidosis (DKA) in 17,596 patients with type 2 diabetes enrolled in the clinical drug development program for the sodium-glucose transport-2 (SGLT-2) inhibitor canagliflozin. Investigators found that DKA occurred at a low frequency in patients taking canagliflozin. Overall, 12 patients experienced severe DKA; of these 4 were receiving canagliflozin 100 mg, 6 were taking canagliflozin 300 mg, and 2 were treated with a comparator drug.