Closed-Loop Basal Insulin Delivery Over 36 Hours in Adolescents With Type 1 Diabetes
Randomized clinical trial
- Daniela Elleri, MD1,2,
- Janet M. Allen, RN1,2,
- Kavita Kumareswaran, MD2,
- Lalantha Leelarathna, MD2,
- Marianna Nodale, MSC2,
- Karen Caldwell, RN2,
- Peiyao Cheng, MPH3,
- Craig Kollman, PHD3,
- Ahmad Haidar, MSC2,
- Helen R. Murphy, MD2,
- Malgorzata E. Wilinska, PHD1,2,
- Carlo L. Acerini, MD1,
- David B. Dunger, MD1,2 and
- Roman Hovorka, PHD1,2⇓
- 1Department of Paediatrics, University of Cambridge, Cambridge, U.K.
- 2Metabolic Research Laboratories, Institute of Metabolic Science, Cambridge, U.K.
- 3The Jaeb Center for Health Research, Tampa, Florida
- Corresponding author: Roman Hovorka, .
OBJECTIVE We evaluated the safety and efficacy of closed-loop basal insulin delivery during sleep and after regular meals and unannounced periods of exercise.
RESEARCH DESIGN AND METHODS Twelve adolescents with type 1 diabetes (five males; mean age 15.0 [SD 1.4] years; HbA1c 7.9 [0.7]%; BMI 21.4 [2.6] kg/m2) were studied at a clinical research facility on two occasions and received, in random order, either closed-loop basal insulin delivery or conventional pump therapy for 36 h. During closed-loop insulin delivery, pump basal rates were adjusted every 15 min according to a model predictive control algorithm informed by subcutaneous sensor glucose levels. During control visits, subjects’ standard infusion rates were applied. Prandial insulin boluses were given before main meals (50–80 g carbohydrates) but not before snacks (15–30 g carbohydrates). Subjects undertook moderate-intensity exercise, not announced to the algorithm, on a stationary bicycle at a 140-beats/min heart rate in the morning (40 min) and afternoon (20 min). Primary outcome was time when plasma glucose was in the target range (71–180 mg/dL).
RESULTS Closed-loop basal insulin delivery increased percentage time when glucose was in the target range (median 84% [interquartile range 78–88%] vs. 49% [26–79%], P = 0.02) and reduced mean plasma glucose levels (128  vs. 165  mg/dL, P = 0.02). Plasma glucose levels were in the target range 100% of the time on 17 of 24 nights during closed-loop insulin delivery. Hypoglycemia occurred on 10 occasions during control visits and 9 occasions during closed-loop delivery (5 episodes were exercise related, and 4 occurred within 2.5 h of prandial bolus).
CONCLUSIONS Day-and-night closed-loop basal insulin delivery can improve glucose control in adolescents. However, unannounced moderate-intensity exercise and excessive prandial boluses pose challenges to hypoglycemia-free closed-loop basal insulin delivery.
- Received April 28, 2012.
- Accepted September 22, 2012.
- © 2013 by the American Diabetes Association.
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