medwireNews: The iLet bionic pancreas closed-loop insulin delivery system provides good glucose control without the need for the user to count carbohydrates, show findings from the pivotal trial.
Instead of counting carbohydrates, users of the Beta Bionics iLet insulin-only bionic pancreas just make meal announcements with the modifier of more, less, or their usual amount of carbohydrates.
“It starts this process we’ve all dreamed of for years, of removing numeracy from the diabetes process,” said researcher Gregory Forlenza (Barbara Davis Center for Diabetes), who opened the presentation at the 82nd ADA Scientific Sessions in New Orleans, Louisiana.
The pivotal trial involved 161 adults (average age 44 years) and 165 children aged at least 6 years (average 12 years) with type 1 diabetes, and had no upper limit on glycated hemoglobin (HbA1c). The average in adults was 7.6% (60 mmol/mol), with a range of 5.5–13.1% (37–120 mmol/mol); in children it was 8.0% (64 mmol/mol), with a range of 5.8–12.2% (40–110 mmol/mol).
During 13 weeks of treatment, there was an average HbA1c reduction of 0.5% in both adults and children randomly assigned to use the bionic pancreas system, relative to those who continued with usual care.
The bionic pancreas system includes a Dexcom G6 continuous glucose monitor (CGM) and was used with aspart or lispro. The comparator group all had a CGM, and used insulin delivery methods ranging from multiple daily injections to hybrid closed-loop systems.
The researchers found larger HbA1c reductions in participants with higher baseline levels. Improvements in glycemic control were consistent across subgroups defined by race/ethnicity, income, and education; and regardless of the insulin delivery device used previously.
Time in range (TIR) improved significantly more by week 13 in the bionic pancreas than control groups, reaching 69% versus 58% in adults and 60% versus 50% in children.
The rate of severe hypoglycemia was not significantly different between the bionic pancreas and usual care groups, at a respective 25.5 versus 14.2 events per 100 person–years in adults and 10.4 versus 7.3 events per 100 person–years in children, and there were no diabetic ketoacidosis events.
Participant-reported outcomes were generally favorable, with adults reporting improvements in disease-related distress and quality of life; the younger participants all scored highly at baseline, with little room for improvement.
Another aspect of the trial was that an additional 114 adults were randomly assigned to use the bionic pancreas with faster aspart with no changes in the control algorithm to account for this. Similar to the main trial results, these people had an average HbA1c reduction of 0.5% relative to standard care.
When compared with the bionic pancreas using aspart/lispro, there was no significant difference in HbA1c or average glucose. However, faster aspart produced a small but significant 2% increase in TIR relative to aspart/lispro, which was limited to the daytime.
Steven Russell (Massachusetts General Hospital, Boston, USA), who presented the data for this part of the trial, said that this “makes sense, because most of the data that we’ve seen in other studies says that the difference is related to a reduction in post-prandial glucose excursion.”
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