RECRUITINGINTERVENTIONAL

DiaMester Pilot RCT: E-health Lifestyle Program for Type 2 Diabetes

DiaMester: E-health Lifestyle Program for Improved Self-management and Remission of Type 2 Diabetes - a Pilot RCT

About This Trial

This registration covers a pilot for a 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).

Who May Be Eligible (Plain English)

Who May Qualify: - Written willing to sign a consent form - Men and women aged ≥ 18 years - Type 2 diabetes of duration 0-6 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1c and/or blood glucose) - HbA1c ≥ 48 mmol/mol at the last routine clinical check, within last 12 months if on diet alone - HbA1c ≥ 43 mmol/mol if on treatment with oral hypoglycaemic agents or GLP-1 RA treatment - Body Mass Index (BMI) \>27 kg/m2 - Stable body weight during the last 6 months with or without the use of weight-reducing drugs - Self-reported desire to lose weight - Owns a smartphone Who Should NOT Join This Trial: - Current insulin use - \> 5% weight change or started treatment with weight reducing drugs\* within the last 6 months. \*orlistat (Xenical), bupropion-naltrekson (Mysimba), fenteramin-topiramat (Qsimba), semaglutid (Wegovy, Ozempic), tirzepatid (Mounjaro), liraglutid (Saxenda, Victoza), dulaglutid (Truicity). - Recent routine HbA1c ≥108 mmol/mol - Recent eGFR \<30 ml/min/1.73 m\^2 - Known cancer - Myocardial infarction within previous 6 months - Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) - Pregnancy/considering pregnancy or exclusively breastfeeding - Substance abuse (drugs, alcohol) - Diagnosed eating disorders or suspected ED based on screening questionnaire - Learning difficulties or unable to understand, speak and read Norwegian or English - Patients who have required hospitalization for depression or are on antipsychotic drugs - People currently participating in another clinical research trial Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Written informed consent * Men and women aged ≥ 18 years * Type 2 diabetes of duration 0-6 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1c and/or blood glucose) * HbA1c ≥ 48 mmol/mol at the last routine clinical check, within last 12 months if on diet alone * HbA1c ≥ 43 mmol/mol if on treatment with oral hypoglycaemic agents or GLP-1 RA treatment * Body Mass Index (BMI) \>27 kg/m2 * Stable body weight during the last 6 months with or without the use of weight-reducing drugs * Self-reported desire to lose weight * Owns a smartphone Exclusion criteria: * Current insulin use * \> 5% weight change or started treatment with weight reducing drugs\* within the last 6 months. \*orlistat (Xenical), bupropion-naltrekson (Mysimba), fenteramin-topiramat (Qsimba), semaglutid (Wegovy, Ozempic), tirzepatid (Mounjaro), liraglutid (Saxenda, Victoza), dulaglutid (Truicity). * Recent routine HbA1c ≥108 mmol/mol * Recent eGFR \<30 ml/min/1.73 m\^2 * Known cancer * Myocardial infarction within previous 6 months * Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) * Pregnancy/considering pregnancy or exclusively breastfeeding * Substance abuse (drugs, alcohol) * Diagnosed eating disorders or suspected ED based on screening questionnaire * Learning difficulties or unable to understand, speak and read Norwegian or English * Patients who have required hospitalization for depression or are on antipsychotic drugs * People currently participating in another clinical research trial

Treatments Being Tested

BEHAVIORAL

e-health lifestyle program

The e-health lifestyle program consists of three parts: 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 lifestyle 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.

BEHAVIORAL

Low calorie diet

Participants will use a low calorie diet (LCD) total diet replacement (TDR) for the first 3 months of the 1 year intervention period, before gradual reintroduction of food.

Locations (1)

Oslo University Hospital

Oslo, Norway