79% time-in-range with insulin and dasiglucagon, up two hours from insulin-only (71% TIR); Time <70 mg/dL down ~33%, time <54 mg/dL down ~50% in bihormonal mode; n=10
In a major pre-commercial milestone, Beta Bionics and Zealand today announced strong results from the first home-use study of the dual-hormone iLet bionic pancreas using Zealand’s liquid-stable dasiglucagon in a pre-filled cartridge. The two-period, 14-day crossover study (n=10), conducted by Dr. Steve Russell’s team at Massachusetts General Hospital, found iLet to operate as expected, meeting all system performance outcomes (e.g., success of drug delivery), and demonstrating superior glycemic control with dasiglucagon compared to insulin-only mode. Participants initiated therapy by entering only their body weight into the device.
In bi-hormonal mode, participants spent 79% time in range (70-180 mg/dL), nearly two hours more per day than the 71% time-in-range with insulin only (p<0.01). Moreover, time spent in hypoglycemia (<70 mg/dl) was 2.4% during the bi-hormonal period and 3.6% during the insulin-only period – a difference of ~17 minutes. Percentage of time <54 mg/dL was 0.3% during the bi-hormonal period and 0.6% during the insulin-only period. Participants achieved a mean glucose of 139 mg/dL during days 2-7 of bi-hormonal mode, compared to 149 mg/dL during days 2-7 of insulin-only mode (p<0.01).
In an email update from last month, Beta Bionics CEO Ed Damiano told us that the company was moving “very fast” toward IDE submissions for pivotal trials in both the insulin-only and bi-hormonal configurations. The insulin-only pivotal trial is now expected in 1Q20 (back from “2H19”), and the bi-hormonal pivotal is now expected in 1H20 (back from “late 2019/early 2020”). Approval for the bi-hormonal iLet is still targeted for 2022.
At last year’s ADA, we saw incredibly similar data from a home-use study using Beta Bionics’ algorithm controlling one or two Tandem t:slim pumps with reconstituted Lilly glucagon: Time-in-range was 79% for the bi-hormonal setup and 72% for insulin-only; mean glucose dropped from 148 mg/dL on insulin-only to 139 mg/dL on bi-hormonal; and both configurations had <1% time <54 mg/dL.
--by Albert Cai, Peter Rentzepis, Maeve Serino, and Kelly Close