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Performance of an Artificial Pancreas System for Young Children with Type 1 Diabetes
Mark D DeBoer1,2, Marc D Breton1, Christian Wakeman1
11 Center for Diabetes Technology, University of Virginia , Charlottesville, Virginia.
Insights
An artificial pancreas (AP) system is safe for young children (5-8 years) with type 1 diabetes, improving blood glucose control without increasing hypoglycemia. This technology offers a promising advancement for pediatric diabetes management.
Area of Science:
- Pediatric Endocrinology
- Biomedical Engineering
- Diabetes Technology
Background:
- Young children (5-8 years) with type 1 diabetes (T1D) require improved glycemic control.
- Limited ability of this age group to safely interact with artificial pancreas (AP) systems presents a challenge.
- Evaluating AP safety and performance in young children with T1D is crucial.
Purpose of the Study:
- To assess the safety and efficacy of an artificial pancreas (AP) system in young children aged 5-8 years with type 1 diabetes (T1D).
Main Methods:
- A randomized, crossover trial comparing AP use with standard insulin pump + continuous glucose monitor (CGM) care at home.
- Participants underwent two 68-hour study periods in random order.
- Analyses adjusted for physical activity tracked via Fitbit devices; hypoglycemia and CGM data were compared.
Main Results:
- Twelve children (median age 7 years) completed the trial.
- AP use significantly increased time in target blood glucose range (70-180 mg/dL) to 73% vs. 47% (P<0.001) and lowered mean blood glucose (152 mg/dL vs. 190 mg/dL) compared to home care.
- Hypoglycemia rates were similar between AP and home care (1.1% vs. 1.6% time <70 mg/dL), with no adverse events reported.
Conclusions:
- Artificial pancreas (AP) system use is safe in young children with type 1 diabetes.
- AP technology improves glycemic control, evidenced by increased time in target blood glucose range and lower mean blood glucose.
- The findings support the potential of AP systems for enhancing diabetes management in pediatric populations.
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.