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

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). The design of the control algorithm was done entirely in silico, i.e., using computer simulation experim...

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Published in:Journal of diabetes science and technology Vol. 4; no. 6; p. 1374
Main Authors: Kovatchev, Boris, Cobelli, Claudio, Renard, Eric, Anderson, Stacey, Breton, Marc, Patek, Stephen, Clarke, William, Bruttomesso, Daniela, Maran, Alberto, Costa, Silvana, Avogaro, Angelo, Dalla Man, Chiara, Facchinetti, Andrea, Magni, Lalo, De Nicolao, Giuseppe, Place, Jerome, Farret, Anne
Format: Journal Article
Language:English
Published: United States 01.11.2010
Subjects:
Adolescent
Adult
Aged
Algorithms
Blood Glucose - drug effects
Blood Glucose - metabolism
Child
Computer Simulation
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
Drug Dosage Calculations
Female
France
Glycated Hemoglobin A - metabolism
Humans
Hypoglycemia - blood
Hypoglycemia - chemically induced
Hypoglycemia - prevention & control
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - adverse effects
Insulin - administration & dosage
Insulin - adverse effects
Insulin Infusion Systems
Italy
Male
Middle Aged
Models, Biological
Monitoring, Physiologic
Pancreas, Artificial
Pilot Projects
Time Factors
Treatment Outcome
Virginia
Young Adult
ISSN:1932-2968, 1932-3107
Online Access:Get more information
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Summary: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). 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. 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). 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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ISSN:1932-2968
1932-3107
DOI:10.1177/193229681000400611