DiaMester Pilot RCT: E-health Lifestyle Program for Type 2 Diabetes
Recruiting · NCT07361640 · Interventional (participants receive a specific treatment) · Lead sponsor: Oslo University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Low calorie diete-health lifestyle program
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Oslo University Hospital - Oslo, Norway