This article is more than 5 years old. Information may no longer be current.
ASPIRE In-home: Artificial pancreas significantly reduced nocturnal hypoglycemia
Click Here to Manage Email Alerts
CHICAGO — Researchers are one step closer to developing an artificial pancreas that can be programmed to prevent hypoglycemia, Richard M. Bergenstal, MD, executive director of the International Diabetes Center at Park Nicollet in St. Louis Park, Minn. told Endocrine Today here at the ADA Scientific Sessions.
“This has been something we’ve been saying is coming for decades now. This study shows that we can move closer to goals and reduce hypoglycemia by approximately 40%, which is very impressive,” he said.
Bergenstal and colleagues from the Automation to Simulate Pancreatic Insulin response (ASPIRE) In-home study group randomly assigned 247 patients to sensor-augmented insulin-pump therapy with the threshold-suspend feature (threshold-suspend group; n=121) or standard sensor-augmented insulin-pump therapy (control group; n=126 patients).
According to data, HbA1c levels were similar in the two groups. However, the mean AUC for nocturnal hypoglycemic events was 37.5% lower among patients in the threshold-suspend group (980 mg/dL × minutes), compared with the control group (1,568 mg/dL × minutes; P<.001).
Further data indicate that nocturnal hypoglycemic events occurred 31.8% less often among patients in the threshold-suspend group (1.5 events per patient week) compared with the control group (2.2 events per patient week; P<.001).
“Those patients wearing the sensor were able to reduce events quite significantly, with no severe reactions,” Bergenstal said.
The percentages of nocturnal sensor glucose values <50 mg/dL, 50 to <60 mg/dL, and 60 to <70 mg/dL were significantly reduced among patients in the threshold-suspend group (P<.001 for each), according to data.
The pump was stopped in 1,438 instances for 2 hours at night, according to data. Moreover, the mean sensor glucose value was 92.6 mg/dL. Although four patients (control group) demonstrated a severe hypoglycemic event, no patients displayed ketoacidosis.
Bergenstal told Endocrine Today that they did not see any rebound hyperglycemia or Protein kinase A. He said he is hopeful that the device will soon be approved by the FDA for clinical use. – by Samantha Costa
For more information:
Bergenstal RM. #48-LB. Presented at: ADA Scientific Sessions; June 21-25, 2013; Chicago.
Bergenstal RM. N Engl J Med. 2013;doi: 10.1056/NEJMoa1303576.
Disclosure: Bergenstal reports being on advisory panels, consultancy for, and/or research support by: Abbott Diabetes Care, AstraZeneca/Bristol-Meyers Squibb, Bayer Health Care, BD Medical Diabetes Care, Boehringer Ingelheim, Calibra Medical, Dexcom, Eli Lilly and Company, Halozyme, Helmsley Charitable Trust, Hygieia, Johnson & Johnson, Medtronic, Merck, Novo Nordisk, Roche, and Sanofi. Other relationships include all contracts with Park Nicollet Institute, and stocks/shareholder with Merck.
Perspective
Back to Top
Anne L. Peters, MD, FACP
In all of the studies, and from my experience, patients tend to stop using continuous glucose monitoring for a variety of reasons. I have also used the MiniMed pump and MiniMed sensor as it currently exists.
When I heard about the threshold suspended system, I thought it was not really going to make a difference, as I cannot get my patients to wear sensors most of the time. I was a skeptic at first, mostly because of how poor the uptake about sensors is in patients with type 1 diabetes.
However, when I heard the data from Dr. Bergenstal, it was the first time I really saw why everybody is so excited. They really had a clinically significant reduction of nocturnal hypoglycemia and there were zero cases of severe hypoglycemia and 4 cases in the controlled group. What we didn’t mention in the press conference was that you often see overtreatment for the lows, and you didn’t really in this study.
Every parent of a patient going away to college will want this. I really like the data. I think it’s impressive and I know there are data from Europe, but this was such a nicely designed clinical trial that was able to show the differences. I think it’s worth using and I’ll be a strong advocate of it because of the data from his recent trial.
Click Here to Manage Email Alerts