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 range

18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT07361640

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Anne-Marie Aas, PhD

+47 47302912 a.m.aas@medisin.uio.no

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials