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Randomized Controlled Trial
. 2015 Nov 17;10(2):405-13.
doi: 10.1177/1932296815616134.

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

Monika Reddy  1 , Pau Herrero  2 , Mohamed El Sharkawy  2 , Peter Pesl  2 , Narvada Jugnee  3 , Darrell Pavitt  3 , Ian F Godsland  3 , George Alberti  3 , Christofer Toumazou  2 , Desmond G Johnston  3 , Pantelis Georgiou  2 , Nick S Oliver  3
Affiliations
Randomized Controlled Trial

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

Monika Reddy et al. J Diabetes Sci Technol. .

Abstract

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 (<3.9 mmol/l) and hyperglycemia (>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/m(2), 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.

Keywords: Bio-inspired Artificial Pancreas; closed-loop insulin delivery; diabetes technology; type 1 diabetes.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Flowchart of trial design. The overall trial design of the 24-hour randomized controlled crossover closed-loop study, followed by the substudy evaluating the BiAP algorithm without and with partial meal announcement assessment as outlined in this article.
Figure 2.
Figure 2.
Median (IQR) sensor glucose (A), median (IQR) blood glucose (B), and median (IQR) insulin (excluding the meal boluses) (C) delivered for all 12 subjects during the 24-hour closed-loop (green line) and open-loop (blue line) study. Standardized meals (black squares) were provided at 19:00 hours (80 g CHO), 07:00 hours (40 g CHO), and 12:00 hours (50 g CHO). Triangles denote episodes of rescue CHO (10-15 g CHO) for hypoglycemia.
See this image and copyright information in PMC

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