Journal Article

Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial

Moon, Jun Sung, Song, Sun Ok, Bae, Jae Hyun, Kwak, Soo Heon, Kim, Jae Hyeon, Jin, Sang-Man, Bae, Ji Cheol, Chon, Suk, Yoo, Jee Hee, Jung, Chang Hee, Moon, Sun Joon, Yang, Yeoree, Kang, Eun Seok, Suh, Sunghwan, Kim, Ji Yoon

2024

Overview

Aims/hypothesis This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP). Methods This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19–69 years with type 1 diabetes who had HbA 1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks. Stratified block randomisation was conducted by an independent statistician. Blinding was not possible due to the nature of the intervention. The primary outcome was the percentage of time in range (TIR), blood glucose between 3.9 and 10.0 mmol/l, as measured by continuous glucose monitoring. ANCOVAs were conducted with baseline values and study centres as covariates. Results A total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p <0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA 1c decreased from 50.9±9.9 mmol/mol (6.8±0.9%) at baseline to 45.9±7.4 mmol/mol (6.4±0.7%) after 12 weeks in the intervention group and from 48.7±9.1 mmol/mol (6.6±0.8%) to 45.7±7.5 mmol/mol (6.3±0.7%) in the control group (difference between the adjusted means: −0.7 mmol/mol [95% CI −2.0, 0.8 mmol/mol] (−0.1% [95% CI −0.2%, 0.1%]), p =0.366). No diabetic ketoacidosis or severe hypoglycaemia events occurred in either group. Conclusions/interpretation The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP. Trial registration Clinical Research Information Service (CRIS) KCT0008398 Funding The study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056). Graphical Abstract

• Publisher: Springer Berlin Heidelberg,Springer Nature B.V
• Subject: Adult / Aged / Automation / Blood Glucose - analysis / Blood Glucose - drug effects / Blood Glucose - metabolism / Blood Glucose Self-Monitoring - methods / Diabetes / Diabetes mellitus (insulin dependent) / Diabetes Mellitus, Type 1 - blood / Diabetes Mellitus, Type 1 - drug therapy / Female / Glucose / Glucose monitoring / Glycated Hemoglobin - analysis / Glycated Hemoglobin - metabolism / Human Physiology / Humans / Hypoglycemia / Hypoglycemic Agents - administration & dosage / Hypoglycemic Agents - therapeutic use / Insulin / Insulin - administration & dosage / Insulin - therapeutic use / Insulin Infusion Systems / Internal Medicine / Ketoacidosis / Male / Medicine / Medicine & Public Health / Metabolic Diseases / Middle Aged / Pharmacovigilance / Republic of Korea / Young Adult