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Observational Study
. 2025 May;68(5):948-960.
doi: 10.1007/s00125-025-06366-x. Epub 2025 Feb 11.

One-year real-world benefits of Tandem Control-IQ technology on glucose management and person-reported outcomes in adults with type 1 diabetes: a prospective observational cohort study

Jolien De Meulemeester  1 , Bart Keymeulen  2 , Christophe De Block  3 , Liesbeth Van Huffel  4 , Youri Taes  5 , Dominique Ballaux  6 , Katrien Spincemaille  7 , Bruno Lapauw  8 , Gerd Vanhaverbeke  9 , Ine Lowyck  10 , Chris Vercammen  11 , Ides M Colin  12 , Vanessa Preumont  13 , Sara Charleer  1 , Steffen Fieuws  14 , Chantal Mathieu  1 , Pieter Gillard  15
Affiliations
Observational Study

One-year real-world benefits of Tandem Control-IQ technology on glucose management and person-reported outcomes in adults with type 1 diabetes: a prospective observational cohort study

Jolien De Meulemeester et al. Diabetologia. 2025 May.

Abstract

Aims/hypothesis: This multicentre prospective observational cohort study aimed to evaluate real-world changes in glycaemic and person-reported outcomes after 1 year's use of Control-IQ technology in adults with type 1 diabetes.

Methods: Adults who started with Control-IQ between December 2021 and December 2022 were consecutively recruited in 13 Belgian diabetes centres. Data were collected at start and after 4, 8 and 12 months. The primary endpoint was the evolution of time in range (TIR; glucose levels of 3.9-10.0 mmol/l). Data are reported as mean ± SD or least-squares mean (95% CI).

Results: A total of 473 adults were included, with a mean age of 38.5 ± 13.1 years and of whom 57.3% were female. TIR increased from 58.8% (95% CI 56.7, 60.9) at start to 70.9% (69.1, 72.8) at 12 months (p<0.001). HbA1c decreased from 57.3 mmol/mol (56.1, 58.5) (7.4% [7.3, 7.5]) to 49.5 mmol/mol (48.5, 50.6) (6.7% [6.6, 6.8]) and time <3.9 mmol/l from 4.2% (3.9, 4.6) to 1.9% (1.8, 2.1) (all p<0.001). Participants scored better on the Hypoglycaemia Fear Survey version 2 worry (22.5 [21.3, 23.7] vs 18.1 points [17.0, 19.3]), the Problem Areas in Diabetes - Short Form (7.2 [6.7, 7.8] vs 6.1 points [5.5, 6.7]), and the Diabetes Treatment Satisfaction Questionnaire status (25.5 [24.8, 26.2] vs 31.0 points [30.4, 31.6]) (all p<0.001). The number of self-reported severe hypoglycaemia events (37.5 [21.3, 65.9] vs 15.7 [9.7, 25.3] events per 100 person-years, p=0.002) and work absenteeism days (116.3 [42.8, 315.5] vs 69.3 [25.4, 189.2] days per 100 person-years, p=0.034) decreased.

Conclusions/interpretation: One-year use of Control-IQ was associated with better glucose management, improved diabetes-related quality of life, more treatment satisfaction, less severe hypoglycaemia and less work absenteeism in adults with type 1 diabetes.

Trial registration: ClinicalTrials.gov NCT04414280.

Keywords: Automated insulin delivery; Control-IQ technology; Hybrid closed-loop; T:slim X2; Type 1 diabetes mellitus.

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Conflict of interest statement

Acknowledgements: The authors would like to thank the data nurses, the local investigators and their teams for monitoring the participants, collecting the data and completing the case reporting files. We would also like to thank R. Carette and S. Getteman (KU Leuven, Leuven, Belgium) for their help in gathering and processing data from the study. Parts of this study were presented at the 17th International Conference On Advanced Technologies & Treatments For Diabetes, 6–9 March 2024 in Florence, Italy and at the 60th International Conference On European Association for the Study of Diabetes, 9–13 September 2024 in Madrid, Spain. Data availability: The datasets generated during and/or analysed in the current study are available from the corresponding author upon reasonable request. Funding: This work was supported by a research grant from Tandem Diabetes Care and Dexcom. Authors’ relationships and activities: JDM received research support from Tandem Diabetes Care and Dexcom via KU Leuven. JDM serves or has served on the speakers bureau for Dexcom; financial compensation for these activities has been received by KU Leuven. CDB reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Insulet, Medtronic, Novo Nordisk and Roche. LVH reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, Merck Sharp and Dohme, Novo Nordisk, Sanofi-Aventis and Roche. YT reports honoraria for speaking for Boehringer Ingelheim, Eli Lilly, Daiichi Sankyo and Bayer. KS reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic and Merck Sharp and Dohme. GV serves, or has served, on the advisory panel for Merck Sharp and Dohme, Boehringer Ingelheim and Eli Lilly. GV reports consulting fees and honoraria for speaking for Merck Sharp and Dohme, Boehringer Ingelheim, AstraZeneca, Sanofi-Aventis, Novo Nordisk and Eli Lilly. CV reports honoraria for speaking for Eli Lilly. IMC reports honoraria for speaking for Novo Nordisk, Eli Lilly, Sanofi and Abbott. IMC serves, or has served, on the advisory panel for Novo Nordisk, Eli Lilly, Sanofi and Abbott. VP reports consulting fees and honoraria for speaking for Novo Nordisk, Sanofi and Abbott. SC received research support from Roche Diabetes Care, Novo Nordisk and Sanofi via KU Leuven. CM serves or has served on the advisory panel for Novo Nordisk, Sanofi, Merck Sharp and Dohme, Eli Lilly, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Imcyse, Insulet, Zealand Pharma, Avotres, Mannkind, Sandoz and Vertex. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for CM from Medtronic, Imcyse, Novo Nordisk, Sanofi and ActoBio Therapeutics; CM serves or has served on the speakers bureau for Novo Nordisk, Sanofi, Eli Lilly, Boehringer Ingelheim, AstraZeneca and Novartis. Financial compensation for these activities has been received by KU Leuven. CM is president of EASD. All external support of EASD is to be found on www.easd.org . PG serves or has served on the advisory panel for Novo Nordisk, Sanofi-Aventis, Boehringer Ingelheim, Janssen Pharmaceuticals, Roche, Medtronic, Abbott and Bayer. Financial compensation for these activities has been received by KU Leuven. PG serves or has served on the speakers bureau for Merck Sharp and Dohme, Boehringer Ingelheim, Bayer, Medtronic, Insulet, Novo Nordisk, Abbott, Roche, VitalAire and Dexcom. Financial compensation for these activities has been received by KU Leuven. KU Leuven received for PG non-financial support for travel from Sanofi-Aventis, A. Menarini Diagnostics, Novo Nordisk, Medtronic and Roche. Contribution statement: JDM designed the study, collected and analysed the data, performed statistical analyses, wrote the manuscript and made figures and tables. BK, CDB, LVH, YT, DB, KS, BL, GV, IL, CV, IMC, VP and SC collected and discussed the data and edited the manuscript. SF provided statistical advice and edited the manuscript. CM and PG designed the study, analysed and discussed the data and wrote the manuscript. All authors approved the final version to be published. JDM and PG are guarantors of this work and, as such, had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

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