Safety and Glycemic Outcomes During the MiniMed TM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes
Authors' conclusion
In children and adolescents with T1D, MiniMed AHCL system use was safe, A1C was lower, and TIR was increased. The lowest GT and shortest AIT were associated with the highest TIR and lowest TBR and TAR, all of which met consensus-recommended glycemic targets.
Study context
- Population
- Children and adolescents aged 7–17 years with T1D, 13 investigational centersITT population
- Participants
- 160 children
- Comparison
- Advanced hybrid closed-loop (AHCL) vs run-in
- Outcome
- Primary safety and effectiveness endpoints: A1C, TIR, severe hypoglycemia and DKA
Methodological detailspivotal trial, multicentre (13 investigational centers), run-in period
- Pivotal trial
- Multicentre (13 investigational centers)
- Run-in period
Main finding
As reported in the abstract
end of study
A1C reduced from baseline (N = 160) to end of study (N = 136); P < 0.001
7.9 ± 0.9% to 7.4 ± 0.7%
Overall TIR increased from run-in to end of study; P < 0.001
59.4 ± 11.8% to 70.3 ± 6.5%
Further findings
Active insulin time (AIT) 2 h (N = 19) vs longer AIT settings (N = 52), with 100 mg/dL GT
- Mean TIR with AIT 2 h
- 73.4%
- TBR <70 mg/dL reduced
- 3.5% to 2.2%
- TAR >180 mg/dL reduced
- 28.7% to 24.4%
Safety
Severe hypoglycemia and diabetic ketoacidosis (DKA) during AHCL use
- Severe hypoglycemia
- 0
- DKA
- 0
Original publication
Safety and Glycemic Outcomes During the MiniMed TM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther. Published 25 October 2023. doi:10.
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