Research Article
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Published Online: 1 May 2017

Performance of an Artificial Pancreas System for Young Children with Type 1 Diabetes

Publication: Diabetes Technology & Therapeutics
Volume 19, Issue Number 5

Abstract

Background: Young children 5–8 years old with type 1 diabetes (T1D) exhibit clear needs for improved glycemic control but may be limited in their ability to safely interact with an artificial pancreas system. Our goal was to evaluate the safety and performance of an artificial pancreas (AP) system among young children with T1D.
Research Design and Methods: In a randomized, crossover trial, children with T1D age 5–8 years were enrolled to receive on separate study periods (in random order) either the UVa AP using the DiAs Control Platform software with child-resistant lock-out screens (followed as an out-patient admission) or their usual insulin pump+continuous glucose monitor (CGM) care at home. Hypoglycemic events and CGM tracings were compared between the two 68-h study periods. All analyses were adjusted for level of physical activity as tracked using Fitbit devices.
Results: Twelve participants (median age 7 years, n = 6 males) completed the trial. Compared to home care, the AP admission resulted in increased time with blood glucose (BG) 70–180 mg/dL (73% vs. 47%) and lower mean BG (152 mg/dL vs. 190 mg/dL), both P < 0.001 after adjustment for activity. Occurrence of hypoglycemia was similar between sessions without differences in time <70 mg/dL (AP 1.1% ± 1.1%; home 1.6% ± 1.2%). There were no adverse events during the AP or home study periods.
Conclusions: Use of an AP in young children was safe and resulted in improved mean BG without increased hypoglycemia. This suggests that AP use in young children is safe and improves overall diabetes control.
ClinicalTrials.gov registration number: NCT02750267.

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Published In

cover image Diabetes Technology & Therapeutics
Diabetes Technology & Therapeutics
Volume 19Issue Number 5May 2017
Pages: 293 - 298
PubMed: 28426239

History

Published in print: May 2017
Published online: 1 May 2017
Published ahead of print: 20 April 2017

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Mark D. DeBoer
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
Division of Pediatric Endocrinology, Department of Pediatrics, University of Virginia, Charlottesville, Virginia.
Marc D. Breton
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
Christian Wakeman
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
Elaine M. Schertz
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
Emma G. Emory
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
Jessica L. Robic
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
Laura L. Kollar
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
Boris P. Kovatchev
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
Daniel R. Cherñavvsky
Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.
TypeZero Technologies, Inc., Charlottesville, Virginia.

Notes

Address correspondence to:Daniel R. Cherñavvsky, MDCenter for Diabetes TechnologyUniversity of VirginiaPO Box 400888Charlottesville, VA 22903E-mail: [email protected]

Author Disclosure Statement

M.D.B. and B.P.K. receive research support from Tandem, DexCom, Roche, Sanofi, Ascencia (former Bayer Diabetes), and BD. M.D.B. consults for Roche, Sanofi, Ascencia, and DexCom. B.P.K. consults for Sanofi. Both M.D.B. and B.P.K. are founders of TypeZero Technologies, Inc. D.R.C. is part-time Chief Medical Officer for TypeZero. M.D.D., C.W., E.G.E., and L.L.K. have no conflicts of interest to declare.

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