Type 2 Diabetes Patients Can Also Benefit From Fully Closed-Loop System

Even patients with type 2 diabetes can benefit from using a fully closed-loop insulin delivery system, also known as an artificial pancreas, according to an open-label crossover trial.

In the randomized trial of 28 adults, patients spent a greater average proportion of time in target glucose range — 70 to 180 mg/dL (3.9 to 10.0 mmol/L) — while on the closed-loop system compared with a control period (66.3% [±14.9] vs 32.3% [±24.7], P<0.001), reported Charlotte Boughton, MRCP, PhD, of the University of Cambridge in the U.K., and colleagues.

Closed-loop users also spent less time in hyperglycemia — blood glucose over 180 mg/dL — than during a control period using a standard insulin therapy (33.2% [±14.8] vs 67.0% [±25.2]), the researchers noted in Nature Medicine.

“Many people with type 2 diabetes struggle to manage their blood sugar levels using the currently available treatments, such as insulin injections,” Boughton pointed out in a statement. “The artificial pancreas can provide a safe and effective approach to help them, and the technology is simple to use and can be implemented safely at home.”

The researchers explained that fully closed-loop systems, which are more convenient and have no requirement for user input at meal times, have previously been shown to improve glucose control in people with type 2 diabetes in the inpatient setting, and in an outpatient setting in those requiring dialysis over a period of 20 days. Any benefits beyond a few months, however, had been unclear, the team added.

The CamAPS HX fully closed-loop system used in the new study was also safe — not increasing the time spent in hypoglycemia (under 70 mg/dL; 0.44% vs 0.08% in the control period), the investigators reported. This system is currently approved for use only in the U.K. and the European Union, but several other closed-loop systems are FDA approved for patients with type 1 diabetes.

There also weren’t any episodes of severe hypoglycemia, the team said, adding, however, that users did report being a bit more worried about hypoglycemia while using the closed-loop system.

“One of the barriers to widespread use of insulin therapy has been concern over the risk of severe ‘hypos’ — dangerously low blood sugar levels,” study co-author Aideen Daly, MD, also of the University of Cambridge, explained in a statement. “But we found that no patients on our trial experienced these and patients spent very little time with blood sugar levels lower than the target levels.”

While on the closed-loop system, patients had a lower average glucose level during the course of the 8-week trial (mean 166 vs 226.8 mg/dL [9.2 vs 12.6 mmol/L]). Additionally, HbA1c was also significantly lower during the closed-loop period (7.3% vs 8.7% during the control period).

One treatment-related serious adverse event occurred with the closed-loop system, with a patient requiring hospitalization due to an abscess at the pump cannula site requiring incision and drainage.

Also, one participant reported being unable to manage the device (and thus withdrew from the study during the crossover period); the rest of the participants reported being highly satisfied with the system.

A total of 89% of the participants said they spent less time managing their diabetes. Some of the highlights of the system, users noted, included less need for injections or finger-prick testing, and greater confidence in managing their disease.