Metabolic Control With the Bio-inspired Artificial Pancreas in Adults With Type 1 Diabetes: A 24-Hour Randomized Controlled Crossover Study

• Published in: Journal of diabetes science and technology 2016-03, Vol.10 (2), p.405-413
• Main Authors: Reddy, Monika, Herrero, Pau, Sharkawy, Mohamed El, Pesl, Peter, Jugnee, Narvada, Pavitt, Darrell, Godsland, Ian F., Alberti, George, Toumazou, Christofer, Johnston, Desmond G., Georgiou, Pantelis, Oliver, Nick S.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Blood Glucose; Cross-Over Studies; Diabetes Mellitus, Type 1 - therapy; Female; Humans; Male; Middle Aged; Original; Pancreas, Artificial
• ISSN: 1932-2968; 1932-2968; 1932-3107
• DOI: 10.1177/1932296815616134

Background: The Bio-inspired Artificial Pancreas (BiAP) is a closed-loop insulin delivery system based on a mathematical model of beta-cell physiology and implemented in a microchip within a low-powered handheld device. We aimed to evaluate the safety and efficacy of the BiAP over 24 hours, followed by a substudy assessing the safety of the algorithm without and with partial meal announcement. Changes in lactate and 3-hydroxybutyrate concentrations were investigated for the first time during closed-loop. Methods: This is a prospective randomized controlled open-label crossover study. Participants were randomly assigned to attend either a 24-hour closed-loop visit connected to the BiAP system or a 24-hour open-loop visit (standard insulin pump therapy). The primary outcome was percentage time spent in target range (3.9-10 mmol/l) measured by sensor glucose. Secondary outcomes included percentage time in hypoglycemia (10 mmol/l). Participants were invited to attend for an additional visit to assess the BiAP without and with partial meal announcements. Results: A total of 12 adults with type 1 diabetes completed the study (58% female, mean [SD] age 45 [10] years, BMI 25 [4] kg/m2, duration of diabetes 22 [12] years and HbA1c 7.4 [0.7]% [58 (8) mmol/mol]). The median (IQR) percentage time in target did not differ between closed-loop and open-loop (71% vs 66.9%, P = .9). Closed-loop reduced time spent in hypoglycemia from 17.9% to 3.0% (P < .01), but increased time was spent in hyperglycemia (10% vs 28.9%, P = .01). The percentage time in target was higher when all meals were announced during closed-loop compared to no or partial meal announcement (65.7% [53.6-80.5] vs 45.5% [38.2-68.3], P = .12). Conclusions: The BiAP is safe and achieved equivalent time in target as measured by sensor glucose, with improvement in hypoglycemia, when compared to standard pump therapy.