Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes
An erratum to this article was published (J Diabetes Sci Technol, Nov 2024 ↗)
Primary result · TIR (70-180 mg/dL)Result — go to the resultChange in TIR from baseline 18.6 % CI 11.4–25.9Authors' conclusion
This clinical trial of the open-source AAPS hybrid closed-loop system performed in an at-home setting demonstrated comparable safety to stand-alone pump therapy. The glycemic outcomes of AAPS were superior with improved TIR, and there was no significant difference in TBR compared with stand-alone pump therapy.
Study context
- Population
- Adults with T1D on established pump therapy; 60% women, aged 45.8 ± 15.9 years, diabetes duration 23.9 ± 13.2 years, baseline HbA1c 7.5% ± 0.5%, time in range (TIR) 62.3% ± 12.9%
- Participants
- 20 adults
- Comparison
- AndroidAPS HCL vs stand-alone insulin pump therapy
- Primary endpoint
- Difference in percentage TIR (70-180 mg/dL)
- Follow-up
- Final week of each four-week study arm
Methodological detailsopen-label, single-center, crossover
- Open-label
- Single-center
- Crossover
Primary result
TIR (70-180 mg/dL) · final week of each four-week arm
Change in TIR from baseline
18.6 %
CI 11.4–25.9
P < 0.001
By group
AAPSvs Stand-alone pump
change in TIR from baseline 18.6 % (CI 11.4–25.9); P < 0.001
As reported in the abstract
Safety
| Outcome | Mean (%) | P value |
|---|---|---|
| Time glucose <54 mg/dLNot increased | −2.0 | P = 0.191 |
Serious adverse events and severe hypoglycemia
- Serious adverse events or episodes of severe hypoglycemia
- 0
Original publication
Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes. J Diabetes Sci Technol. Published 14 February 2023. doi:10.
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