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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Information & Authors
Information
Published In
Diabetes Technology & Therapeutics
Volume 19 • Issue Number 5 • May 2017
Pages: 293 - 298
PubMed: 28426239
Copyright
Copyright 2017, Mary Ann Liebert, Inc.
History
Published in print: May 2017
Published online: 1 May 2017
Published ahead of print: 20 April 2017
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Authors
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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