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Metabolic Control With the Bio-inspired Artificial Pancreas in Adults With Type 1 Diabetes: A 24-Hour Randomized
Monika Reddy1, Pau Herrero2, Mohamed El Sharkawy2
1Division of Diabetes, Endocrinology and Metabolism, Imperial College London, UK m.reddy@imperial.ac.uk.
The Bio-inspired Artificial Pancreas (BiAP) is a safe closed-loop system for type 1 diabetes management. It achieved similar time in target glucose range as standard therapy but significantly reduced hypoglycemia.
Area of Science:
- Biomedical Engineering
- Endocrinology
- Diabetes Technology
Background:
- The Bio-inspired Artificial Pancreas (BiAP) is a novel closed-loop insulin delivery system utilizing a mathematical model of beta-cell physiology.
- It is implemented on a microchip within a low-powered handheld device for diabetes management.
- This study investigated the safety and efficacy of the BiAP system over 24 hours.
Purpose of the Study:
- To evaluate the safety and efficacy of the Bio-inspired Artificial Pancreas (BiAP) in adults with type 1 diabetes.
- To assess the impact of BiAP on glucose control, specifically time in target range, hypoglycemia, and hyperglycemia.
- To investigate changes in lactate and 3-hydroxybutyrate concentrations during closed-loop operation for the first time.
Main Methods:
- A prospective, randomized, controlled, open-label, crossover study design was employed.
- Participants were randomized to either a 24-hour closed-loop visit using BiAP or a 24-hour open-loop visit with standard insulin pump therapy.
- Primary outcome was percentage time in sensor glucose target range (3.9-10 mmol/l); secondary outcomes included time in hypoglycemia and hyperglycemia.
Main Results:
- The BiAP system demonstrated equivalent median time in target range (71% vs 66.9%) compared to standard insulin pump therapy (P = .9).
- Closed-loop operation significantly reduced time spent in hypoglycemia (17.9% to 3.0%, P < .01) but increased time in hyperglycemia (10% vs 28.9%, P = .01).
- Time in target was higher with full meal announcement during closed-loop compared to no or partial announcement (65.7% vs 45.5%, P = .12).
Conclusions:
- The Bio-inspired Artificial Pancreas (BiAP) is safe for use in adults with type 1 diabetes.
- The BiAP system achieved comparable time in target glucose range to standard insulin pump therapy.
- BiAP demonstrated a significant improvement in reducing hypoglycemia, highlighting its potential as an advanced diabetes management tool.
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