An insulin pump that shuts off when the looped-in, continuous glucose monitor detects low glucose levels reduced nighttime hypoglycemia and prevented serious events. Note that the insulin pump was not associated with increasing glycated hemoglobin values.

CHICAGO – An insulin pump that takes a break when the looped-in, continuous glucose monitor detects low glucose levels reduced nighttime hypoglycemia and prevented serious events, according to results of the ASPIRE trial in type 1 diabetes.

The mean severity and duration of nocturnal hypoglycemia fell by 38% as measured by area-under-the-curve compared with the same device without the software (P<0.001), Richard Bergenstal, MD, of the International Diabetes Center at Park Nicollet in St. Louis Park, Minn., and colleagues found.

Overall glucose control didn’t suffer, they reported here at the American Diabetes Association meeting and simultaneously online in the New England Journal of Medicine.

No severe hypoglycemia occurred with devices set to suspend insulin dosing for 2 hours after hitting the 70 mg/dL glucose threshold compared with four events among patients whose pumps did not have the extra programming.

”That’s probably one of the first studies ever to show no severe hypoglycemia,” Bergenstal told reporters at a press conference.

”This idea of automating insulin, putting some ’brains’ in the pump, is really something worth continuing to explore,” he added. ”This is the beginning.”

These findings with the new feature is part of the insulin pump MiniMed Veo

”Hypoglycemia is their limiting step, it’s what makes them afraid of tight glycemic control,” she commented in an interview with MedPage Today. ”Reducing it, and even the perception that you have less, will make people potentially feel more confident, and I really think that matters.”

Devices are still a few major steps away from truly mimicking the pancreas. But predicting rather than reacting to already low glucose levels, having the pump alter dose based on trends throughout the day, and adding glucagon to the pump to manage hypoglycemia are in the works.

”For the first time in my 30 years, I’m really feeling this artificial pancreas is feasible,” Bergenstal said. ”Before it was a dream, now we have the first part of it and I think we will see this develop.”

His Automation to Simulate Pancreatic Insulin Response (ASPIRE) In-Home Study included 247 type 1 diabetes patients with documented nocturnal hypoglycemia randomized to receive the continuous glucose monitor-linked insulin pump with or without the threshold-suspend feature for 3 months.

The threshold can be programmed to suspend insulin at 60 to 90 mg/dL but usually is set at 70 mg/dL.

The number of nocturnal hypoglycemia events dropped to an average of 1.5 per week in patients with the threshold-suspend device versus 2.2 per week in the control group, a 32% relative difference (P<0.001). More than two-thirds of hypoglycemia happened at night.

Overall day and night events were likewise 30% less common with the threshold-suspend feature (3.3 versus 4.7 per week, P<0.001).

The feature cut down more on the more severe events, with a relative 40% reduction in mild hypoglycemia of 60 to 70 mg/dL but a 57% reduction in events reaching under 50 mg/dL.

Risk of rebound hyperglycemia after 2-hour insulin suspension was low.

The concern was that glucose might shoot too high, ”but we were pleased to see that at the end of that 2-hour suspension blood sugar was 92 or 93 mg/dL,” Bergenstal noted. ”It had just drifted back up to the normal range.”

For the primary safety endpoint, hemoglobin A1c levels were similar between the threshold-suspend pump therapy and the control group (7.24% and 7.14%, which met non-inferiority criteria).

Treatment characteristics were similar between groups in terms of total insulin dosage, boluses, sensor wear and calibration, and body weight change, which Bergenstal said supported the software as the main factor in the results.

Although the study included only patients with documented nocturnal hypoglycemic episodes, that shouldn’t limit generalizability, he told MedPage Today at the briefing.

Most patients with type 1 diabetes do experience nighttime hypoglycemia at least a couple of times a month, Peters noted.

The benefits of reducing hypoglycemia were seen across the whole age and A1c spectrum, with fairly similar impact for patients ages 16 to 70, Bergenstal added.

From www.medpagetoday.com

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