Study protocol: Safety and efficacy of smart watch integrated do-it-yourself continuous glucose monitoring in adults with Type 1 diabetes, a randomised controlled trial

Abstract

Purpose: Type 1 diabetes (T1D) management requires regular monitoring of glucose levels and judicious therapeutic administration of insulin to prevent both microvascular and macrovascular complications. Few people with diabetes are able to sustain the self-monitored blood glucose measurements needed for optimal care, and those that do, typically experience significant diabetes-related distress. Both intermittently scanned continuous glucose monitoring (isCGM) and continuous glucose monitoring (CGM) offer alternatives to reduce the overall burden, but both still have limitations. Given the expense of CGM, smart watch integrated do-it-yourself (DIY)-CGM has been developed as an alternative to commercial isCGM and CGM technologies. This study has been designed to evaluate the clinical efficacy of smart watch integrated DIY-CGM compared with isCGM in adults with T1D. Methods: This multicentre, randomised, crossover study will be conducted in New Zealand and aims to recruit 60 adults with established T1D who currently use isCGM. DIY-CGM will be compared to usual care with isCGM. Participants will be randomised to either arm of the study for 8 weeks followed by a 4-week washout period before crossing over to the other study arm for a further 8 weeks. The primary endpoint is glucose time in range (TIR) defined as percentage of time interstitial glucose is spent between 3.9 to 10 mmol/L for the entire intervention period. Secondary endpoints include diabetes-related quality of life, distress, and sleep quality in participants and their partners. Discussion: The results of this study will provide clinical trial data regarding smart watch integrated DIY-CGM versus isCGM for improving glycaemic control in adults with T1D, and also report a variety of key secondary outcomes, including changes in subjective outcome measures for both people with diabetes and their partners. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12621000648820,31 May 2021); World Health Organisation International Clinical Trial Registry Platform (U1111-1262–2784, 3rd December 2020).