JOURNAL ARTICLE
MULTICENTER STUDY

Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: summary of the results

Boris Kovatchev, Claudio Cobelli, Eric Renard, Stacey Anderson, Marc Breton, Stephen Patek, William Clarke, Daniela Bruttomesso, Alberto Maran, Silvana Costa, Angelo Avogaro, Chiara Dalla Man, Andrea Facchinetti, Lalo Magni, Giuseppe De Nicolao, Jerome Place, Anne Farret
Journal of Diabetes Science and Technology 2010 November 1, 4 (6): 1374-81
21129332

BACKGROUND: In 2008-2009, the first multinational study was completed comparing closed-loop control (artificial pancreas) to state-of-the-art open-loop therapy in adults with type 1 diabetes mellitus (T1DM).

METHODS: The design of the control algorithm was done entirely in silico, i.e., using computer simulation experiments with N=300 synthetic "subjects" with T1DM instead of traditional animal trials. The clinical experiments recruited 20 adults with T1DM at the Universities of Virginia (11); Padova, Italy (6); and Montpellier, France (3). Open-loop and closed-loop admission was scheduled 3-4 weeks apart, continued for 22 h (14.5 h of which were in closed loop), and used a continuous glucose monitor and an insulin pump. The only difference between the two sessions was that insulin dosing was performed by the patient under a physician's supervision during open loop, whereas insulin dosing was performed by a control algorithm during closed loop.

RESULTS: In silico design resulted in rapid (less than 6 months compared to years of animal trials) and cost-effective system development, testing, and regulatory approvals in the United States, Italy, and France. In the clinic, compared to open-loop, closed-loop control reduced nocturnal hypoglycemia (blood glucose below 3.9 mmol/liter) from 23 to 5 episodes (p<.01) and increased the amount of time spent overnight within the target range (3.9 to 7.8 mmol/liter) from 64% to 78% (p=.03).

CONCLUSIONS: In silico experiments can be used as viable alternatives to animal trials for the preclinical testing of insulin treatment strategies. Compared to open-loop treatment under identical conditions, closed-loop control improves the overnight regulation of diabetes.

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