番茄社区

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ORLANDO -- The novel Omnipod and Diabeloop closed-loop systems looked safe and more effective than conventional management of type 1 diabetes in trial programs with increasingly real-world scenarios, researchers said here.

In the study of 11 adults using the hybrid closed-loop Omnipod HorizonT system for 5 days under free-living conditions while staying in a hotel, mean glucose levels were similar to those during a 7 day period on standard therapy but the time in the 70 to 180 mg/dL range was 73.7% versus 62.5% (P=0.02).

The system didn't reduce overall hyperglycemia but did cut severe episodes over 250 mg/dL (4.5% vs 8.5%, P=0.01), reported Bruce Buckingham, MD, of Stanford University in Stanford, California, at the American Diabetes Association (ADA) annual meeting.

The closed-loop glucose monitoring and insulin delivery system also improved hypoglycemia (1.9% vs 5.1%, P=0.001), especially overnight hypoglycemia (0.7% vs 5.7%, P=0.02).

In the trial of the hybrid closed-loop Diabeloop DBLG1 system that also was presented at the ADA, overall time in target was 69.3% among patients randomized to that system versus 56.6% in patients who stayed on their usual pump and Dexcom continuous glucose monitoring (CGM), a significant difference that amounted to an extra 3 hours per day in the 70- to 180-mg/dL range.

Among the 67 patients randomized at 12 centers in France for 12 weeks of device use at home under regular life conditions without any restrictions on diet or exercise, glucose levels were about 12 mg/dL lower on average in the closed-loop group.

Proportion of time in hypoglycemia fell significantly to 2% compared with 4.5% in the open-loop group, while nocturnal hypoglycemia dropped to about a third of that in the open-loop controls (1.3% vs 3.9%), "a major point for quality of life," said Sylvia Franc, MD, of Sud Francilien Hospital in Corbeil-Essonnes, France.

While the findings from these studies are "exciting," ADA press conference moderator Irl Hirsch, MD, of the University of Washington Medical Center in Seattle, said "a frequent question I have when hearing these kinds of advances is once regulatory approval occurs, how long will it take it to make this to an average patient?"

He cited data showing that only 30% of U.S. type 1 diabetes patients use insulin pumps, and even among patients at specialized diabetes clinics, only 29% of type 1 diabetes patients of all ages use CGM systems.

Reimbursement has been improving access, Hirsch noted, but the needs for infrastructure and offices for training and follow-up are still issues, along with lack of interchangeability across the number of devices under development.

"We need to do a better job of standardizing the playing field so these can all talk to each other -- and not just for the patient, but also for the providers," he told 番茄社区 at the press conference.

The Diabeloop device has been submitted for regulatory clearance in Europe, but talks are still underway with FDA on whether the European data could be used for by the agency without a new trial in the U.S.

An open-loop version of the Omnipod insulin pump system, the Omnipod Dash, was approved earlier this month.