OBJECTIVE:Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control-IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control. METHODS: In a randomized controlled trial, 24 adolescents (ages 13-18 years) and 24 school-aged children (6-12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor-augmented pump (RM-SAP), and the experimental group used the t: slim X2 with Control-IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff. RESULTS: The Control-IQ system improved percent time within range (70-180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events. CONCLUSIONS: The use of the Control-IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM-SAP in pediatric patients with T1D during prolonged intensive winter sport activities.
RCT Entities:
OBJECTIVE: Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control-IQ AP system in adolescents and children during a winter skicamp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control. METHODS: In a randomized controlled trial, 24 adolescents (ages 13-18 years) and 24 school-aged children (6-12 years) with Type 1 diabetes (T1D) participated in a 48 hours skicamp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor-augmented pump (RM-SAP), and the experimental group used the t: slim X2 with Control-IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff. RESULTS: The Control-IQ system improved percent time within range (70-180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events. CONCLUSIONS: The use of the Control-IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM-SAP in pediatric patients with T1D during prolonged intensive winter sport activities.
Authors: Mark A Clements; Nicole C Foster; David M Maahs; Desmond A Schatz; Beth A Olson; Eva Tsalikian; Joyce M Lee; Christine M Burt-Solorzano; William V Tamborlane; Vincent Chen; Kellee M Miller; Roy W Beck Journal: Pediatr Diabetes Date: 2015-07-08 Impact factor: 4.866
Authors: Daniela Elleri; Janet M Allen; Marianna Nodale; Malgorzata E Wilinska; Jasdip S Mangat; Anne Mette F Larsen; Carlo L Acerini; David B Dunger; Roman Hovorka Journal: Diabetes Technol Ther Date: 2011-02-28 Impact factor: 6.118
Authors: Nicole C Foster; Roy W Beck; Kellee M Miller; Mark A Clements; Michael R Rickels; Linda A DiMeglio; David M Maahs; William V Tamborlane; Richard Bergenstal; Elizabeth Smith; Beth A Olson; Satish K Garg Journal: Diabetes Technol Ther Date: 2019-01-18 Impact factor: 6.118
Authors: Eda Cengiz; Dongyuan Xing; Jenise C Wong; Joseph I Wolfsdorf; Morey W Haymond; Arleta Rewers; Satya Shanmugham; William V Tamborlane; Steven M Willi; Diane L Seiple; Kellee M Miller; Stephanie N DuBose; Roy W Beck Journal: Pediatr Diabetes Date: 2013-03-08 Impact factor: 4.866
Authors: David M Maahs; Bruce A Buckingham; Jessica R Castle; Ali Cinar; Edward R Damiano; Eyal Dassau; J Hans DeVries; Francis J Doyle; Steven C Griffen; Ahmad Haidar; Lutz Heinemann; Roman Hovorka; Timothy W Jones; Craig Kollman; Boris Kovatchev; Brian L Levy; Revital Nimri; David N O'Neal; Moshe Philip; Eric Renard; Steven J Russell; Stuart A Weinzimer; Howard Zisser; John W Lum Journal: Diabetes Care Date: 2016-07 Impact factor: 19.112
Authors: Marc D Breton; Daniel R Cherñavvsky; Gregory P Forlenza; Mark D DeBoer; Jessica Robic; R Paul Wadwa; Laurel H Messer; Boris P Kovatchev; David M Maahs Journal: Diabetes Care Date: 2017-08-30 Impact factor: 19.112
Authors: Alexander O'Donovan; Sean M Oser; Jessica Parascando; Arthur Berg; Donald E Nease; Tamara K Oser Journal: J Patient Cent Res Rev Date: 2021-07-19
Authors: Max L Eckstein; Benjamin Weilguni; Martin Tauschmann; Rebecca T Zimmer; Faisal Aziz; Harald Sourij; Othmar Moser Journal: J Clin Med Date: 2021-05-31 Impact factor: 4.241