First Outpatient Clinical Trial of a Full Closed-Loop Artificial Pancreas System in South America
Authors' conclusion
The results obtained demonstrated the feasibility of outpatient full CL regulation of glucose levels involving the ARG algorithm and the InsuMate platform.
Study context
- Population
- Adults with meals of 38 to 120 g CHO and daily mild exercise (3–5 km walks), outpatient setting
- Participants
- 5 adults
- Comparison
- Automatic regulation of glucose (ARG) algorithm full closed-loop vs open-loop control
- Outcome
- Glycaemic control
- Follow-up
- 72 hours
Methodological detailsphase 3, crossover of 72 h closed-loop and 72 h open-loop control, Own artificial pancreas (AP) and remote monitoring platform (InsuMate) developed from open-source resources
- Phase 3
- Crossover of 72 h closed-loop and 72 h open-loop control
- Own AP and remote monitoring platform (InsuMate) developed from open-source resources
Main finding
As reported in the abstract
Time in hyperglycemia, open-loop (OL) vs closed-loop (CL)
52.2% [16.3%] OL vs 48.0% [15.4%] CL
TIR, OL vs CL
46.9% [15.6%] OL vs 50.9% [14.4%] CL
Mean glucose, OL vs CL
188.9 [25.5] mg/dl OL vs 186.2 [24.7] mg/dl CL
Average time in CL achieved by InsuMate
more than 95%
Safety
- No severe hyperglycemia or hypoglycemia episodes during the trial
Original publication
First Outpatient Clinical Trial of a Full Closed-Loop Artificial Pancreas System in South America. J Diabetes Sci Technol. Published 12 May 2022. doi:10.
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