https://diabetes.acponline.org/archives/2016/10/07/8.htm

Spotlight on new technologies for type 1 diabetes

Two recent studies and FDA approval of the first “artificial pancreas” highlight new technological advances in type 1 diabetes care.


Two recent studies and FDA approval of the first “artificial pancreas” highlight new technological advances in type 1 diabetes care.

The MiniMed 670G hybrid closed-loop system has been approved to automatically monitor glucose and provide appropriate basal insulin doses, the FDA announced on Sept. 28. The approval of the device for patients ages 14 years and older with type 1 diabetes was based on a study published online in JAMA on Sept. 15. The trial, which was funded by device manufacturer Medtronic, included 124 patients with a baseline daily insulin dose of 47.5 U and a mean HbA1c of 7.4%. After a 2-week run-in to learn to use the device, patients wore it for 3 months. The devices were in closed-loop mode 87.2% of the time, the study found. Patients' mean HbA1c decreased to 6.9%, and the average daily dose of insulin increased to 50.9 U. The percentage of sensor glucose values within the target range changed from 66.7% at baseline to 72.2% at the end of the study. No episodes of severe hypoglycemia or ketoacidosis were observed, although the FDA noted in its approval that risks include hypoglycemia, hyperglycemia, and skin irritation and redness. The FDA is requiring a postmarket study to better understand how the device performs in real-world settings, and the manufacturer is studying its effectiveness in children 7 to 13 years of age.

A new technology for monitoring glucose was described and tested in a recent study published by The Lancet on Sept. 12. The sensor-based, externally worn flash glucose-monitoring system displayed a current glucose reading, 8 hours of historic data, and trends whenever the user scanned it with a reader. It was designed to remain calibrated for 14 days of wear. The study, which lasted for 6 months, randomized 120 patients with type 1 diabetes to use the device and compared their outcomes to 121 patients in a control group (mean baseline HbA1c in total study population, 7.5%). The device group had a reduction in mean time in hypoglycemia, defined as blood glucose level less than 70 mg/dL (<3.89 mmol/L), from 3.38 h/d to 2.03 h/d, compared to a reduction from 3.44 h/d to 3.27 h/d in controls (between-group difference, −1.24 hours; P<0.0001). The device group averaged 15.1 scans per day during the study while the control group averaged 5.7 tests of their glucose per day. No device-related hypoglycemia or safety issues were reported, although some patients had skin reactions. The authors concluded that the technology holds promise “as an effective alternative to conventional self-monitoring of glucose.”

The authors of both studies noted that their research was limited by inclusion of only relatively healthy patients with well-controlled type 1 diabetes and that the results might not be generalizable to other populations. A comment accompanying the study in The Lancet agreed, noting that studies in wider populations, “in which aspects of behavior modification induced by this technology can be ascertained, are needed to provide further guidance to health-care providers and funders, as well as comparisons with emerging automated insulin-delivery systems.”