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Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes

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posted on 21.12.2020, 19:04 by Lauren G. Kanapka, R. Paul Wadwa, Marc D. Breton, Katrina J. Ruedy, Laya Ekhlaspour, Gregory P. Forlenza, Eda Cengiz, Melissa J. Schoelwer, Emily Jost, Lori Carria, Emma Emory, Liana J. Hsu, Stuart A. Weinzimer, Mark D. DeBoer, Bruce A. Buckingham, Mary Oliveri, Craig Kollman, Betsy B. Dokken, Daniel Cherñavvsky, Roy W. Beck, the iDCL Trial Research Group
Objective: To further evaluate the safety and efficacy of the Control-IQ closed loop control (CLC) system in children with type 1 diabetes.

Research Design and Methods: Following a 16-week randomized clinical trial (RCT) comparing CLC with sensor augmented pump (SAP) therapy in 101 children age 6 to 13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks.

Results: In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55±13% using SAP during the RCT to 65±10% using CLC (P<0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP (P=0.03). Substantial improvement in TIR was seen after the first day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% (P<0.001). In the CLC-CLC cohort, mean TIR increased from 53±17% pre-randomization to 67±10% during the RCT and remained reasonably stable at 66±10% through the 12-weeks post-RCT. There were no episodes of diabetic ketoacidosis or severe hypoglycemia in either cohort.

Conclusions: This further evaluation of the Control-IQ CLC system supports the findings of the preceding RCT that use of a closed-loop system can safely improve glycemic control in children 6 to 13 years old with type 1 diabetes from the first day of use and demonstrates that these improvements can be sustained through 28 weeks of use.

Funding

Study funded by Tandem Diabetes, Inc. and the National Institute of Diabetes and Digestive and Kidney Diseases. Tandem Diabetes Care provided the experimental closed-loop systems used in the trial, system-related supplies including the Dexcom CGM and Roche glucometer, and technical expertise.

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