Safety and Effectiveness of MiniMed TM 780G Advanced Hybrid Closed-Loop Use with Ultrarapid Insulin Lispro-AABC in Pediatric and Adult Type 1 Diabetes.
Halis K Akturk, Laura M Nally, Rayhan A Lal et al.
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In 30 seconds
This 19-site, single-arm clinical trial evaluated MiniMed 780G advanced hybrid closed-loop use with ultrarapid insulin lispro-aabc (URLi) in children, adolescents, and adults with type 1 diabetes. After a run-in using rapid-acting insulin, 101 pediatric and 110 adult participants used URLi with the system for 3 months. Compared with run-in, time in range increased by 17.4% in pediatric participants and 10.6% in adults (P < 0.001 for both). Adult A1c fell from 7.4 ± 0.9% to 6.9 ± 0.6% (P < 0.001), while pediatric A1c was unchanged. No severe hypoglycemia or diabetic ketoacidosis events occurred.
Key findings
- Time in range increased by 17.4% in pediatric participants and 10.6% in adults versus run-in (P < 0.001 for both).
- Time in tight target range increased by 16.0% in pediatric participants and 11.6% in adults (P < 0.001 for both).
- Adult A1c decreased from 7.4 ± 0.9% to 6.9 ± 0.6% (P < 0.001); pediatric A1c was unchanged.
- No severe hypoglycemia or diabetic ketoacidosis events were reported.
Why it matters
The findings suggest that this automated insulin-delivery system can be used with URLi while improving several glycemic measures in both pediatric and adult participants. The results are relevant to understanding how a faster-acting insulin performs in an established closed-loop system, while the single-arm design means they do not establish comparative effectiveness against another insulin or system.
What to keep in mind
The study was single-arm, with a 3-month study period; outcomes were compared with run-in data and predefined thresholds rather than a concurrent control group.