Closed-loop insulin delivery systems clear clinical tests

The Orange County Convention Center, where the data were presented. (Visitor7/CC BY-SA 3.0)

Diabeloop and Insulet’s hybrid closed-loop insulin delivery systems have outperformed existing approaches to the management of Type 1 diabetes. The clinical trial data suggest the more integrated approaches to monitoring glucose and delivering insulin are safe and may offer advantages over today’s setups.

Hybrid closed-loop systems add an algorithm to the pumps and continuous glucose monitors (CGM) that are at the leading edge of diabetes care today. The use of an algorithm enables the pump to adjust the delivery of insulin based on CGM data, creating a system that mimics the function of the pancreas in healthy people. While current hybrid closed-loop systems fall short of completely automating insulin control, they have nonetheless raised hopes that simpler, more effective diabetes care is on the horizon.

The potential for systems in development at Diabeloop and Insulet to live up to that promise was discussed at the American Diabetes Association (ADA) 2018 Scientific Sessions over the weekend. New data on both technologies was presented at the event.

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Data on the Diabeloop system came from a clinical trial of 68 patients. Around half of the participants continued to use a Dexcom sensor and CellNovo pump as an open-loop system, while the rest were given the Diabeloop DBLG1 closed-loop system. Over 12 weeks, users of the Diabeloop system spent 69% of the time in the target blood glucose range, compared to 57% in the control arm. Patients in the control arm spent longer in hypoglycemia, both overall and at night.

Researchers studying the Omnipod hybrid closed-loop system also reported improvements in the time spent in the target range and out of hypoglycemia. In the 11-patient trial, the Omnipod system kept participants in the target range 74% of the time, compared to 63% for the standard therapy.

Talking at the ADA event, Irl Hirsch, M.D., a diabetes specialist at the University of Washington Medical Center, was upbeat about the significance of the technologies and the data they generated. But he flagged the potential for a lag between approval and uptake to dull their impact on patients, as has happened with CGMs.

"From my point of view, these are all very exciting new advances in diabetes technology, especially for people with Type 1 diabetes," Hirsch said at a press conference attended by Medscape. "Without even considering costs, there's the need for the infrastructure and offices for training and follow-up. How can we do a better job of getting these important tools to our patients who need them the most?"

Neither hybrid closed-loop system is cleared for sale in the U.S. Diabeloop has filed for the CE mark it needs to start providing its device in Europe.

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