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

IF 8.4 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetologia Pub Date : 2025-02-11 DOI:10.1007/s00125-025-06366-x

Jolien De Meulemeester, Bart Keymeulen, Christophe De Block, Liesbeth Van Huffel, Youri Taes, Dominique Ballaux, Katrien Spincemaille, Bruno Lapauw, Gerd Vanhaverbeke, Ine Lowyck, Chris Vercammen, Ides M. Colin, Vanessa Preumont, Sara Charleer, Steffen Fieuws, Chantal Mathieu, Pieter Gillard

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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). HbA_1c 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

Graphical Abstract

查看原文本刊更多论文

一项前瞻性观察队列研究：串联控制- iq技术对成人1型糖尿病患者血糖管理和个人报告结果的一年实际获益

目的/假设：本多中心前瞻性观察队列研究旨在评估成人1型糖尿病患者使用Control-IQ技术1年后血糖和个人报告结果的真实变化。方法：在2021年12月至2022年12月期间，在13个比利时糖尿病中心连续招募了开始使用Control-IQ的成年人。在开始和4、8、12个月后收集数据。主要终点是时间范围的演变(TIR；葡萄糖水平3.9-10.0 mmol/l)。数据以均数±SD或最小二乘平均值（95% CI）报告。结果共纳入成人473例，平均年龄38.5±13.1岁，其中女性占57.3%。TIR从开始时的58.8% （95% CI 56.7, 60.9）增加到12个月时的70.9% (69.1,72.8)（p<0.001）。HbA1c从57.3 mmol/mol(56.1, 58.5)（7.4%[7.3, 7.5]）降至49.5 mmol/mol(48.5, 50.6)(6.7%[6.6, 6.8])，时间从3.9 mmol/l从4.2%（3.9,4.6）降至1.9% (1.8,2.1)（p < 0.001）。参与者在低血糖恐惧调查第二版忧虑（22.5[21.3,23.7]对18.1分[17.0,19.3]），糖尿病问题领域-简短形式（7.2[6.7,7.8]对6.1分[5.5,6.7]）和糖尿病治疗满意度问卷状态（25.5[24.8,26.2]对31.0分[30.4,31.6]）（所有p<；0.001）得分更高。自我报告的严重低血糖事件（每100人年37.5 [21.3,65.9]vs 15.7[9.7, 25.3]事件，p=0.002）和旷工天数（每100人年116.3 [42.8,315.5]vs 69.3[25.4, 189.2]天，p=0.034）减少。结论/解释1型糖尿病成人患者使用1年Control-IQ与更好的血糖管理、改善糖尿病相关生活质量、更高的治疗满意度、更少的严重低血糖和更少的旷工有关。临床试验注册：clinicaltrials .gov nct04414280

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来源期刊

Diabetologia 医学-内分泌学与代谢

CiteScore

18.10

自引率

2.40%

发文量

193

审稿时长

1 months

期刊介绍： Diabetologia, the authoritative journal dedicated to diabetes research, holds high visibility through society membership, libraries, and social media. As the official journal of the European Association for the Study of Diabetes, it is ranked in the top quartile of the 2019 JCR Impact Factors in the Endocrinology & Metabolism category. The journal boasts dedicated and expert editorial teams committed to supporting authors throughout the peer review process.