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. 2024 Nov;18(6):1281-1287.
doi: 10.1177/19322968241229074. Epub 2024 Feb 7.

Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology

Viral N Shah  1 , Halis K Akturk  1 , Alex Trahan  2 , Nicole Piquette  2 , Alex Wheatcroft  2 , Elain Schertz  2 , Karen Carmello  2 , Lars Mueller  2 , Kirstin White  2 , Larry Fu  2 , Ravid Sassan-Katchalski  2 , Laurel H Messer  2 , Steph Habif  2 , Alex Constantin  2 , Jordan E Pinsker  2
Affiliations

Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology

Viral N Shah et al. J Diabetes Sci Technol. 2024 Nov.

Abstract

Background: Optimization of automated insulin delivery (AID) settings is required to achieve desirable glycemic outcomes. We evaluated safety and efficacy of a computerized system to initialize and adjust insulin delivery settings for the t:slim X2 insulin pump with Control-IQ technology in adults with type 1 diabetes (T1D).

Methods: After a 2-week continuous glucose monitoring (CGM) run-in period, adults with T1D using multiple daily injections (MDI) (N = 33, mean age 36.1 years, 57.6% female, diabetes duration 19.7 years) were transitioned to 13 weeks of Control-IQ technology usage. A computerized algorithm generated recommendations for initial pump settings (basal rate, insulin-to-carbohydrate ratio, and correction factor) and weekly follow-up settings to optimize glycemic outcomes. Physicians could override the automated settings changes for safety concerns.

Results: Time in range 70 to 180 mg/dL improved from 45.7% during run-in to 69.1% during the last 30 days of Control-IQ use, a median improvement of 18.8% (95% confidence interval [CI]: 13.6-23.9, P < .001). This improvement was evident early in the study and was sustained over 13 weeks. Time <70 mg/dL showed a gradual decreasing trend over time. Percentage of participants achieving HbA1c <7% went from zero at baseline to 55% at study end (P < .001). Only six of the 318 automated settings adaptations (1.9%) were overridden by study investigators.

Conclusions: Computerized initiation and adaptation of Control-IQ technology settings from baseline MDI therapy was safe in adults with T1D. The use of this simplified system for onboarding and optimizing Control-IQ technology may be useful to increase uptake of AID and reduce staff and patient burden in clinical care.

Keywords: Control-IQ; adaptation; automated insulin delivery; initialization; t:slim X2.

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: VNS has received research grants through University of Colorado from Tandem Diabetes Care, Insulet, NovoNordisk, Alexion, JDRF and NIH. He has received fees through University of Colorado for speaking or consulting work for Dexcom, Insulet, Tandem Diabetes Care, Embecta, NovoNordisk and Medscape. HKA has received research grants through University of Colorado from Tandem Diabetes Care, Medtronic, Dexcom, Eli Lilly, Mannkind. He has received consulting fees through University of Colorado from Tandem Diabetes Care, Medtronic and Dexcom. AT, NP, AW, ES, KC, LM, KW, LF, RSK, LM, SH, AC, and JEP are employees of Tandem Diabetes Care, Inc.

Figures

Figure 1.
Figure 1.
Median time in range 70 to 180 mg/dL compared from run-in through each 30-day period. Time in range improved from 45.7% during run-in to 69.1% during the last 30 days of Control-IQ use, with most of the improvement evident early on, and then sustained through 13 weeks. This represents a median improvement of 18.8% (95% CI: 13.6-23.9, P < .001).
See this image and copyright information in PMC

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