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BOSTON -- Type 1 diabetes patients using a closed-loop system that administered quick, small doses of glucagon fared better than those on placebo, researchers reported here.
Twenty-two adult patients who used an insulin pump or multiple daily injections and were at high risk of hypoglycemia were randomized to receive very small, automatic doses of glucagon or placebo. The area over curve of time spent with blood glucose levels <60 mg/dL, a measure of hypoglycemia, was reduced by 75% for those on glucagon versus placebo (851 mg/dL versus 3,414 mg/dL per minute, P<0.001) in the 2-week trial, according to , at Massachusetts General Hospital (MGH) in Boston, and colleagues.
Action Points
- This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
"This study was very impressive to us because this was the that was blinded, and there were no adverse events, and no significant nausea between the two groups," Ekhlaspour told MedPage Today in an interview at the Endocrine Society annual meeting.
Because insulin takes a long time to be absorbed, the researchers wanted to see how patients using a closed loop, automatic glucagon distribution system that gave out quick doses based on automatic user feedback would fare, she explained.
All patients had a continuous glucose monitor that would send data to an iPhone every 5 minutes, and based on an algorithm, glucagon would then be delivered if the patients needed it. All patients had a self-reported average frequency of hypoglycemia of at least twice a week, and said that they had inconsistent symptoms when their blood glucose was under 50 mg/dL, so it was hard to tell when they were in danger.
During the trial, all patients delivered their own insulin as usual, and the glucagon or placebo was delivered via coded devices. Days receiving glucagon or placebo were randomized in such a way that patients spent 7 days on one and then 7 days on the other.
In a secondary analysis, the authors found that there was a 91% reduction in area over curve of <60 mg/dL at night on glucagon versus placebo days (117 versus 1,309 mg/dL per minute, P<0.0001).
In addition, there were half as many symptomatic hypoglycemia episodes on glucagon versus placebo days (0.6 versus 1.2 incidents per day, P<0.0001), and overall patients spent 74% less time with blood glucose <60 mg/dL on glucagon versus placebo days (1.2% versus 4.7%, P<0.0001).
The authors tested to see if blinding was effective, and found that participants correctly guessed whether they were on glucagon or placebo only 42% of the time, which was similar to chance. There was no significant difference between the groups when it came to amount of glucagon administered. On days that patients received glucagon, the mean total daily dose was 0.48 mg.
Self-reported nausea was more common in the glucagon group, but this difference was not significant (P=0.05). There were no unexpected or severe adverse events on glucagon or placebo days.
Co-author , also at MGH, told ľֱ that there was no indication that patients changed behavior on the devices. Results from longer trials should show similar results as shorter ones, he added.
"We plan to continue this trial and use an automated glucagon delivery system in patients" that are prone to hypoglycemia because of endogenous insulin production, Ekhlaspour stated.
In related news, the developer of a "bionic pancreas," which delivers glucagon and insulin, announced that he was forming a . Early prototypes of the device were essentially an iPhone connected to two delivery systems, but the latest device from Beta Bionics, called the iLet, looks and acts like a single device, explained , of Boston University.
Other companies are also developing artificial pancreases, but a marketable version of the device is still at least a couple of years away. Damiano said that a version of the device that delivers insulin-only could hit the market in 2018, adding that large trial with the device is planned for 2017.
Disclosures
Ekhlaspour disclosed no relevant relationships with industry.
Russell disclosed relevant relationships with Tandem Diabetes Care, Sanofi, Speaker, Eli Lilly, Dexcom, and Companion Medical.
Primary Source
The Endcrine Society
Ekhlaspour L, et al "Closed-loop glucagon administration for the automated prevention and treatment of hypoglycemia in type 1 diabetes" ENDO 2016; OR12-1.