Session: OR12-Fresh Thoughts on Diabetes Treatment
Room 210 (BCEC)
Clinical Fellows Abstract in Diabetes
Material and Methods: We conducted a double-blinded, randomized, placebo controlled crossover study involving 22 adult subjects with type 1 diabetes who used an insulin pump or multiple daily injections, had a self-reported average frequency of hypoglycemia <60 mg/dl of at least twice a week, and reported inconsistent or absent symptoms with blood glucose <50 mg/dl. Participants administered their own insulin as usual while receiving either glucagon or placebo (filled from coded vial blinding devices) for 24 hours at a time from an automated bionic pancreas system. During the 2-week study, days were randomized to glucagon or placebo in blocks of two (7 days of each). The primary outcome was area over the curve <60 mg/dl (AOC<60), a measure of total hypoglycemia exposure, on glucagon vs. placebo days. Secondary outcomes included AOC<60 during the nighttime (11:00 PM – 7:00 AM), time <60 mg/dl, incidents of symptomatic hypoglycemia, mean CGM glucose, mean glucagon dosing on glucagon days, and daily self-reported nausea on a visual analog scale.
Results: The AOC <60 mg/dl was reduced by 75% on glucagon vs. placebo days (851 ± 748 vs. 3,414 ± 2,242 mg/dl·min, p<0.001). There was a 91% reduction in AOC<60 at night on glucagon vs. placebo days (117 ± 204 vs. 1,309 ± 1,476 mg/dl·min, p<0.0001). Subjects spent 74% less time with BG <60 mg/dL on glucagon vs. placebo days (1.2 ± 0.8% versus 4.7 ± 3.6%; p<0.0001). There were half as many symptomatic hypoglycemia episodes on glucagon vs. placebo days (0.6 ± 0.4 versus 1.2 ± 0.8 incidents per day; p<0.0001). Blinding was effective, with subjects correctly guessing their daily assignment to glucagon or placebo in a daily survey on 42% of days (similar to chance). There was no difference in mean CGM glucose on glucagon vs. placebo days (153 ± 28 vs. 152 ± 27 mg/dl, p=0.6). The mean total daily dose of glucagon was 0.48 mg on glucagon days. There was a trend for more self-reported nausea on glucagon vs. placebo days, but this did not reach statistical significance (1.1 ± 0.6 vs. 0.4 ± 0.7 cm on a 10 cm scale, p=0.05). There was no unexpected or severe adverse events on either glucagon or placebo days.
Conclusions: Automated glucagon administration effectively reduced hypoglycemia in patients with type 1 diabetes, and was well tolerated.
Disclosure: SJR: Scientific Board Member, Tandem Diabetes Care, Ad Hoc Consultant, Sanofi, Speaker, Eli Lilly & Company, Principal Investigator, Eli Lilly & Company, Principal Investigator, Tandem Diabetes Care, Speaker, Dexcom, Speaker, Sanofi, Principal Investigator, Dexcom, Scientific Board Member, Companion Medical. Nothing to Disclose: LE, CB, FHE, DM, MS, KLM, MH, LD
*Please take note of The Endocrine Society's News Embargo Policy at https://www.endocrine.org/news-room/endo-annual-meeting/pr-resources-for-endo
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