Performance of an Artificial Pancreas System for Young Children with T1D

Presentation Number: OR12-2
Date of Presentation: April 4th, 2017

Mark Daniel DeBoer*1, Marc D. Breton1, Christian Wakeman2, Elaine Schertz2, Emma G. Emory2, Jessica L. Robic2, Laura L. Kollar2, Boris P. Kovatchev1 and Daniel R Chernavvsky1
1Univ of Virginia, Charlottesville, VA, 2Univ. of Virginia

Abstract

Background: While use of the artificial-pancreas (AP) in adults and adolescents with type 1 diabetes (T1D) has been shown to improve blood glucose (BG) control, its ability to improve BG control is unclear among young children age 5-8 years. These children may have additional risks of AP use because of immature abilities to interact with system settings and insulin bolus commands.

Objective: To evaluate safety and efficacy of an artificial-pancreas (AP) system adapted for use among young children with T1D.

Research Design and Methods: In a randomized, cross-over trial, 12 children with T1D age 5-8y received, in separate 68-hour study periods (in randomized order), either an AP with child-resistant lock-out screens (followed as an out-patient admission) or their usual insulin pump+CGM care (at home). All analyses were performed using models that adjusted for level of physical activity tracked using Fitbit devices.

Results: Trial participants consisted of twelve children 5-8 years old (n=6 males) with median (intraquartile range) characteristics as follows: age 7 (6.75, 7.25) years, duration of diabetes 3.7 (2.9, 5.7) years, HbA1c 7.7% (7.1, 7.8), and total daily insulin 20.3 (15.7, 22.2) units. The AP admission had a higher amount of physical activity: total steps AP 41,002+12,661 vs. home 21,046+14,354; average heart rate AP 96.9 +6.2 beats/min vs. home 92.9+7.3; therefore, all analyses were adjusted for activity level. Compared to home-care, the AP admission resulted in increased time with blood glucose (BG) 70-180mg/dL (AP 73.1+2.7%; home 46.9+2.7%, p=0.002 after adjustment for level of activity) and lower mean BG (AP 152+4.2mg/dL; home 190+7.4%, p<0.001 after adjustment for activity), both p<0.001 after adjustment for activity. Occurrence of hypoglycemia was similar between sessions without differences in time <70mg/dL (AP 6.3+0.2%; home 20.8+1.0%).

Conclusions: Use of an AP adapted for young children resulted in improved mean BG without increased hypoglycemia. This suggests that AP use in young children is safe and improves overall diabetes control.

 

Disclosure: MDB: Consultant, Roche Pharmaceuticals, Consultant, Sanofi, Consultant, Ascencia, Consultant, BD, Founder, Type Zero, Investigator, Tandem, Consultant, Dexcom. BPK: Founder, Type Zero, Investigator, BD, Investigator, Ascencia, Investigator, Roche Pharmaceuticals, Investigator, Tandem, Investigator, Dexcom, Consultant, Sanofi. DRC: Chief Scientific Officer, Type Zero. Nothing to Disclose: MDD, CW, ES, EGE, JLR, LLK