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Clinical Trial
. 2024 Nov;18(6):1288-1292.
doi: 10.1177/19322968241234072. Epub 2024 Mar 5.

Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial

Anders L Carlson  1 , Timothy E Graham  2 , Halis K Akturk  3 , David R Liljenquist  4 , Richard M Bergenstal  1 , Becky Sulik  4 , Viral N Shah  3 , Mark Sulik  4 , Peter Zhao  5 , Peter Briggs  5 , Ravid Sassan-Katchalski  5 , Jordan E Pinsker  5
Affiliations
Clinical Trial

Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial

Anders L Carlson et al. J Diabetes Sci Technol. 2024 Nov.

Abstract

Background: Control-IQ technology version 1.5 allows for a wider range of weight and total daily insulin (TDI) entry, in addition to other changes to enhance performance for users with high basal rates. This study evaluated the safety and performance of the updated Control-IQ system for users with basal rates >3 units/h and high TDI in a multicenter, single arm, prospective study.

Methods: Adults with type 1 diabetes (T1D) using continuous subcutaneous insulin infusion (CSII) and at least one basal rate over 3 units/h (N = 34, mean age = 39.9 years, 41.2% female, diabetes duration = 21.8 years) used the t:slim X2 insulin pump with Control-IQ technology version 1.5 for 13 weeks. Primary outcome was safety events (severe hypoglycemia and diabetic ketoacidosis (DKA)). Central laboratory hemoglobin A1c (HbA1c) was measured at system initiation and 13 weeks. Participants continued using glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose transport protein 2 (SGLT-2) inhibitors, or other medications for glycemic control and/or weight loss if on a stable dose.

Results: All 34 participants completed the study. Fifteen participants used a basal rate >3 units/h for all 24 hours of the day. Nine participants used >300 units TDI on at least one day during the study. There were no severe hypoglycemia or DKA events. Time in range 70-180 mg/dL was 64.8% over the 13 weeks, with 1.0% time <70 mg/dL. Hemoglobin A1c decreased from 7.69% at baseline to 6.87% at 13 weeks (-0.82%, P < .001).

Conclusions: Control-IQ technology version 1.5, with wider range of weight and TDI input and enhancements for users with high insulin requirements, was safe in individuals with T1D in this study.

Keywords: Control-IQ; automated insulin delivery; closed-loop; t:slim X2; total daily insulin.

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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: A.L.C.’s employer, International Diabetes Center, has received research support and/or consulting fees from Eli Lilly, Novo Nordisk, Sanofi, Medtronic, Tandem, Insulet, Dexcom, Abbott Diabetes, and MannKind. T.E.G.’s employer, Diabetes & Endocrine Treatment Specialists, has received research support/and or consulting fees from Novo Nordisk, Eli Lilly, Sanofi, Provention Bio, Novartis, Tandem, Insulet, Ascendis Pharma, and Progenitor Life Sciences. H.K.A. has received research grants through University of Colorado from Tandem Diabetes Care, Medtronic, Dexcom, Eli Lilly, and MannKind and has received consulting fees through University of Colorado from Tandem Diabetes Care, Medtronic, and Dexcom. D.R.L. has received funding for clinical research from Abbott Diabetes Care, Biolinq, Senseonics, Dexcom, Diasome, Sanvita, Medtronic, Tandem, Provention, Eyenuk, TrialNet, and JAEB Center for Clinical Research. R.M.B. has received research support, has acted as a consultant, or has been on the scientific advisory board for Abbott Diabetes Care, Ascensia, Bigfoot Biomedical, Inc, CeQur, Dexcom, Eli Lilly, Embecta, Hygieia, Insulet, Medtronic, Novo Nordisk, Onduo, Roche Diabetes Care, Tandem Diabetes Care, Sanofi, United Healthcare, Vertex Pharmaceuticals, and Zealand Pharma. R.M.B.’s employer, non-profit HealthPartners Institute, contracts for his services, and he receives no personal income from these activities. B.S. has received payments from Medtronic, Insulet, and Tandem as a certified pump trainer, consulting fees from Eli Lilly, honorariums from Medtronic, the Academy of Nutrition & Dietetics, the Association of Diabetes Care & Education Specialists, and the American Diabetes Association. V.N.S. has received research grants through University of Colorado from Tandem Diabetes Care, Insulet, Novo Nordisk, Alexion, JDRF, and NIH and consulting fees through University of Colorado from Dexcom, Insulet, Tandem Diabetes Care, Embecta, Novo Nordisk, and Medscape. M.S. has received consulting fees from Sanvita. P.Z., P.B., R.S.-K., and J.E.P. are employees of Tandem Diabetes Care, Inc.

Figures

Figure 1.
Figure 1.
Change in hemoglobin A1c for different ranges of TDI use with Control-IQ technology version 1.5. Central laboratory measured hemoglobin A1c decreased from 7.69 ± 1.08% at Control-IQ start to 6.87 ± 0.57% at 13 weeks overall, a mean change of −0.82 ± 0.73% (95% CI = −1.08, −0.57; P < .001). Similarly, HbA1c improved for all ranges of TDI use with Control-IQ technology, with the greatest improvement shown for users averaging ≥200 units/day (mean change −1.21 ± 0.67%, P < .001).
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