DiaMester: e-health lifestyle program for self-management and remission of type 2 diabetes – a pilot RCT

This preregistration covers a pilot for 3-armed parallel-group randomized controlled trial (RCT) that will evaluate the efficacy of DiaMester, a Norwegian e-health programme designed to improve self-management and induce clinically meaningful weight loss, and thereby potential remission in adults with type 2 diabetes (T2D). The aim of this pilot RCT is to test the feasibility of the program and to investigate to what extent the program contributes to the intended improvement of lifestyle, self-management, metabolic risk factors and body weight. We also aim to investigate if participants in the e-health program achieve a clinically meaningful weight loss in each of the two intervention arms: one including a low-calorie diet (LCD) total diet replacement (TDR) induction phase and one without the use of a LCD. The DiaMester app serves as a secure communication platform between each participant and an assigned health coach, who provides individually tailored advice on diet and physical activity and monitors progress towards agreed weight-loss targets. Six health coaches (clinical dietitians or diabetes nurses) will deliver the intervention, each having completed the same standardized training prior to study start. Based on the current literature, experience from diabetes and self-management studies that our project group has run, and results from a user-preference study, the e-health program will include: 1) an educational digital course module that can be tailored to the users’ individual needs and preferences. This will include videos and interactive webinars accessible through the program, hosted by health specialists with users as guests. 2) individual and group-based digital coaching by trained health care personnel through secure video-conference and chat solutions. 3) a mobile-phone-based self-management app. This app will offer the user relevant data and information from glucometer and smart watch according to the users’ needs and preferences as well as easy ways for recording dietary intake, physical activity and other relevant parameters.