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

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.

• Authors: Monika Reddy, Pau Herrero, Mohamed El Sharkawy, Peter Pesl, Narvada Jugnee, Darrell Pavitt, Ian F Godsland, George Alberti, Christofer Toumazou, Desmond G Johnston, Pantelis Georgiou, Nick S Oliver
• Journal: Journal of diabetes science and technology (J Diabetes Sci Technol) Vol. 10 Issue 2 Pg. 405-13 (Nov 17 2015) ISSN: 1932-2968 [Electronic] United States
• PMID: 26581881 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 Diabetes Technology Society.

Chemical References

• Blood Glucose

Topics

• Adult
• Aged
• Blood Glucose
• Cross-Over Studies
• Diabetes Mellitus, Type 1 (therapy)
• Female
• Humans
• Male
• Middle Aged
• Pancreas, Artificial