DiaMester Pilot RCT: E-health Lifestyle Program for Type 2 Diabetes (NCT07361640) | Clinical Trial Compass
RecruitingNot Applicable
DiaMester Pilot RCT: E-health Lifestyle Program for Type 2 Diabetes
Norway99 participantsStarted 2026-01-14
Plain-language summary
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 can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Peo…
What they're measuring
1
Change in body weight from baseline (weight loss)
Timeframe: Body weight will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.