Diabetologia · 2025
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.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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De Meulemeester Jolien, Keymeulen Bart, De Block Christophe, Van Huffel Liesbeth, Taes Youri, Ballaux Dominique, Spincemaille Katrien, Lapauw Bruno, Vanhaverbeke Gerd, Lowyck Ine, Vercammen Chris, Colin Ides M, Preumont Vanessa, Charleer Sara, Fieuws Steffen, Mathieu Chantal, Gillard Pieter
Аннотация
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.
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.