Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring
Primary result · Mean change in HbA1c from baselineResult — go to the resultModel-based treatment effect −1.08 percentage points 95% CI −2.17 to 0.00Authors' conclusion
In people with T1D with HbA1c ≥8.0%, the use of AHCL resulted in improved glycemic control relative to MDI + RT-CGM. The scale of improvement suggests that AHCL should be considered as an option for people not achieving good glycemic control on MDI + RT-CGM.
Study context
- Population
- Adults with T1D using MDI + real-time continuous glucose monitoring (RT-CGM) with HbA1c ≥8.0%
- Participants
- 13 adults
- Comparison
- Advanced hybrid closed-loop (AHCL) vs MDI + RT-CGM
- AHCLn = 8
- MDI + RT-CGMn = 5reference
- Primary endpoint
- Between-group difference in mean change from baseline in HbA1c (prespecified endpoint)
- Follow-up
- Six months
Methodological detailsprospective, multicentre, exploratory, open-label, predefined exploratory cohort (cohort B) of ADAPT
- Prospective
- Multicentre
- Exploratory
- Open-label
- Predefined exploratory cohort (cohort B) of ADAPT
Primary result
Mean change in HbA1c from baseline
Model-based treatment effect
−1.08 percentage points
95% CI −2.17 to 0.00
P = 0.0508
Change by group
AHCL
1.70
mean decrease · percentage points
MDI + RT-CGM
0.60
mean decrease · percentage points
As reported in the abstract
Further findings
| Outcome | AHCL | MDI + RT-CGM | Model-based between-group difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| TIR 70–180 mg/dL · study phase | 73.6% | 46.4% | 28.8 (12.3–45.3) | P = 0.0035 | |
| −200204060Difference, percentage points (linear scale) |
Safety
DKA or severe hypoglycemia · 6 months
- No DKA or severe hypoglycemia occurred in either group (AHCL, MDI + RT-CGM)
Original publication
Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring. J Diabetes Sci Technol. Published 22 March 2023. doi:10.
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