Improved Glycemia with Hybrid Closed-Loop Versus Continuous Subcutaneous Insulin Infusion Therapy: Results from a Randomized Controlled Trial
Primary result · Primary: change in A1C, baseline to end of study (Group 1, baseline A1C >8.0%); difference in end-of-study %TBR <70 mg/dL (Group 2, baseline A1C ≤8.0%)Result — go to the resultMean change in A1C, Group 1 −0.8 % 95% CI −1.1% to −0.4%Authors' conclusion
This RCT demonstrates that the MiniMed 670G HCL safely and significantly improved A1C and %TBR <70 mg/dL compared with CSII control in persons with T1D, irrespective of baseline A1C level.
Study context
- Population
- Adults (18–80 years), adolescents and children (2–17 years) with T1D using CSII; Group 1 baseline A1C >8.0%, Group 2 baseline A1C ≤8.0%
- Participants
- 151 vs 151
- Comparison
- MiniMed 670G hybrid closed loop (HCL) vs CSII without CGM
- HCLn = 151
- CSIIn = 151reference
- Primary endpoint
- Change in A1C for Group 1 (baseline A1C >8.0%) and end-of-study difference in %TBR <70 mg/dL for Group 2 (baseline A1C ≤8.0%), superiority of HCL vs control; primary safety: rates of severe hypoglycemia and DKA
- Follow-up
- Baseline to end of study (6 months)
Methodological details1:1 randomisation, superiority (primary) and noninferiority (secondary) endpoints
- 1:1 randomisation
- Superiority (primary) and noninferiority (secondary) endpoints
Primary result
As reported in the abstract
Primary: change in A1C, baseline to end of study (Group 1, baseline A1C >8.0%); difference in end-of-study %TBR <70 mg/dL (Group 2, baseline A1C ≤8.0%) · 6 months
Mean change in A1C, Group 1
−0.8 %
95% CI −1.1% to −0.4%
P < 0.0001
HCLvs CSII
mean change in A1C, Group 1 −0.8 % (95% CI −1.1% to −0.4%); P < 0.0001
- Difference in %TBR <70 mg/dL, Group 2 (the same was observed: significant)
- −4.9% [−6.3% to −3.6%], P < 0.0001
Further findings
| Outcome | Mean change in A1C, Group 2 (%) (95% CI) | P value | |
|---|---|---|---|
| Change in A1C, Group 2 (noninferiority endpoint) · 6 monthsIn favor of HCL intervention | −0.3 (−0.5% to −0.1%) | P < 0.0001 | |
| −0.6−0.4−0.200.2Difference, % (linear scale) |
Difference in %TBR <70 mg/dL, Group 1 (noninferiority endpoint) · 6 months
- Difference in %TBR <70 mg/dL, Group 1 (the same was observed: significant)
- −2.2% [−3.6% to −0.9%], P < 0.0001
Change in A1C and %TBR <70 mg/dL, overall group · 6 months
- Change in A1C and difference in %TBR <70 mg/dL significantly improved, in favor of HCL
Safety
| Outcome | HCL | CSII |
|---|---|---|
| Severe hypoglycemic events during study | 0 events | 6.08 per 100 patient-years |
- Severe hypoglycemic events during study — Severe hypoglycemic events during run-in
- 2
Diabetic ketoacidosis (DKA)
- DKA events during run-in
- 1
Original publication
Improved Glycemia with Hybrid Closed-Loop Versus Continuous Subcutaneous Insulin Infusion Therapy: Results from a Randomized Controlled Trial. Diabetes Technol Ther. Published 20 December 2022. doi:10.
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