Safety and Effectiveness of MiniMed TM 780G Advanced Hybrid Closed-Loop Insulin Intensification in Adults with Insulin-Requiring Type 2 Diabetes
Authors' conclusion
These findings show that MiniMed 780G AHCL use provides safe insulin intensification in type 2 diabetes and significantly improves mean HbA1c and %TIR.
Study context
- Population
- Adults with insulin-requiring T2D using basal-bolus insulin therapy; mean age 60.3 ± 10.8 years, T2D duration 18.6 ± 8.6 years
- Participants
- 95 adults
- Comparison
- MiniMed 780G advanced hybrid closed-loop (AHCL) vs baseline/run-in
- AHCLn = 95
- Outcome
- Primary safety end point: mean change in HbA1c from baseline; primary effectiveness end point: noninferiority in %TIR 70-180 mg/dL (Hodges-Lehmann)
- Follow-up
- End of 3-month study period; %TIR during last 6 weeks
Methodological details13-site, open-label
- 13-site
- Open-label
Main finding
As reported in the abstract
end of 3-month study period
- HbA1c at baseline
- 7.9% ± 1.0% (62.4 ± 10.4 mmol/mol)
- HbA1c at end of study
- 7.2 ± 0.7% (54.7 ± 8.0 mmol/mol)
- HbA1c reduction
- P < 0.001
- %TIR estimate (last 6 weeks)
- 80.9% (95% CI 78.4%, 83.1%)
- Primary (noninferiority) and secondary (superiority) effectiveness criteria met
- P < 0.001
Further findings
Total daily insulin dose · run-in to end of study
- Run-in vs end of study
- 77.4 ± 38.5 U vs. 91.8 ± 49.3 U, P < 0.0001
Daily user-initiated boluses · run-in to end of study
- Run-in vs end of study
- 3.9 ± 1.9 vs. 3.2 ± 1.8, P < 0.0001
Announced carbohydrates, weight and BMI
- Announced carbohydrates unchanged; no significant change in weight or BMI
Safety
- Severe hypoglycemia, diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS)
- 0
- Serious or unanticipated adverse device effects
- 0
Original publication
Safety and Effectiveness of MiniMed TM 780G Advanced Hybrid Closed-Loop Insulin Intensification in Adults with Insulin-Requiring Type 2 Diabetes. Diabetes Technol Ther. Published 6 February 2025. doi:10.
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