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Randomized Controlled Trial
. 2019 Apr;21(4):159-169.
doi: 10.1089/dia.2019.0011. Epub 2019 Mar 19.

Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial

Gregory P Forlenza  1 , Laya Ekhlaspour  2 , Marc Breton  3 , David M Maahs  2 , R Paul Wadwa  1 , Mark DeBoer  3 , Laurel H Messer  1 , Marissa Town  2 , Jennifer Pinnata  3 , Geoff Kruse  4 , Bruce A Buckingham  2 , Daniel Cherñavvsky  3
Affiliations
Randomized Controlled Trial

Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial

Gregory P Forlenza et al. Diabetes Technol Ther. 2019 Apr.

Abstract

Objective: Hybrid closed-loop (HCL) artificial pancreas (AP) systems are now moving from research settings to widespread clinical use. In this study, the inControl algorithm developed by TypeZero Technologies was embedded to a commercial Tandem t:slim X2 insulin pump, now called Control-IQ, paired with a Dexcom G6 continuous glucose monitor and tested for superiority against sensor augmented pump (SAP) therapy. Both groups were physician-monitored throughout the clinical trial.

Research design and methods: In a randomized controlled trial, 24 school-aged children (6-12 years) with type 1 diabetes (T1D) participated in a 3-day home-use trial at two sites: Stanford University and the Barbara Davis Center (50% girls, 9.6 ± 1.9 years of age, 4.5 ± 1.9 years of T1D, baseline hemoglobin A1c 7.35% ± 0.68%). Study subjects were randomized 1:1 at each site to either HCL AP therapy with the Control-IQ system or SAP therapy with remote monitoring.

Results: The primary outcome, time in target range 70-180 mg/dL, using Control-IQ significantly improved (71.0% ± 6.6% vs. 52.8% ± 13.5%; P = 0.001) and mean sensor glucose (153.6 ± 13.5 vs. 180.2 ± 23.1 mg/dL; P = 0.003) without increasing hypoglycemia time <70 mg/dL (1.7% [1.3%-2.1%] vs. 0.9% [0.3%-2.7%]; not significant). The HCL system was active for 94.4% of the study period. Subjects reported that use of the system was associated with less time thinking about diabetes, decreased worry about blood sugars, and decreased burden in managing diabetes.

Conclusions: The use of the Tandem t:slim X2 with Control-IQ HCL AP system significantly improved time in range and mean glycemic control without increasing hypoglycemia in school-aged children with T1D during remote monitored home use.

Keywords: Artificial pancreas; Hybrid closed loop; Pediatrics; Randomized controlled trial; Type 1 diabetes.

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Conflict of interest statement

G.P.F. conducts research sponsored by Medtronic, Dexcom, Abbott, Tandem, Insulet, Bigfoot, Beta Bionics, and TypeZero; he has served as a consultant/speaker for Medtronic, Dexcom, Abbott, and Tandem. D.C. has research support from NLM, the higher education council of Virginia (SCHEV) and his institution (UVA). He is part time CMO of TypeZero Technologies, Inc. (recently acquired by Dexcom, Inc.) and has served as speaker for Tandem and JDRF. L.H.M. has served as a consultant for Tandem Diabetes Care, Clinical Sensors, and Capillary Biomedical. D.M.M. has research support from the NIH, JDRF, NSF, and the Helmsley Charitable Trust and his institution has research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. He has also consulted for Abbott, the Helmsley Charitable Trust, Sanofi, Novo Nordisk, Eli Lilly, and Insulet. M.B. has research support handled by the UVA: Dexcom, Roche, SANOFI, Tandem; Patent Royalties handled by the UVA: SANOFI; Dexcom. Consultant: SANOFI, TANDEM; Ascencia Speaker's Bureau: Roche, Ascencia.

Figures

<b>FIG. 1.</b>
FIG. 1.
Full-day glycemic control during home use. The red line and shaded area represent Control-IQ use and the blue line and shaded area represent SAP use. The shaded area represents the 25th to 75th percentile for glucose values in each group. The center line (plan and dotted) represents the mean. SAP, sensor augmented pump.
<b>FIG. 2.</b>
FIG. 2.
Time in target range 70–180 mg/dL and time in hypoglycemia <70 mg/dL. Subjects in Control-IQ (black) and SAP (gray) along with the 95th confidence interval for the fit around each group.
<b>FIG. 3.</b>
FIG. 3.
Connectivity of the Control-IQ system during home use. System was in closed loop 94.4% of the time, CGM was not connected 4.7% of the time, system was inactive for other system issues 0.9% of the time, and CGM was in warm up for 0% of the time. CGM, continuous glucose monitor; CL.
See this image and copyright information in PMC

References

    1. Bekiari E, Kitsios K, Thabit H, et al. : Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ 2018;361:k1310. - PMC - PubMed
    1. Weisman A, Bai JW, Cardinez M, et al. : Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials. Lancet Diabetes Endocrinol 2017;5:501–512 - PubMed
    1. Dai X, Luo ZC, Zhai L, et al. : Artificial pancreas as an effective and safe alternative in patients with type 1 diabetes mellitus: a systematic review and meta-analysis. Diabetes Ther 2018;9:1269–1277 - PMC - PubMed
    1. Kovatchev B, Patek S, Dassau E, et al. : Control to range for diabetes: functionality and modular architecture. J Diabetes Sci Technol 2009;3:1058–1065 - PMC - PubMed
    1. Patek SD, Magni L, Dassau E, et al. : Modular closed-loop control of diabetes. IEEE Trans Biomed Eng 2012;59:2986–2999 - PMC - PubMed

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