DiaMester e-health lifestyle program for adults with type 2 diabetes (pilot)
DiaMester: E-health Lifestyle Program for Improved Self-management and Remission of Type 2 Diabetes - a Pilot RCT
This pilot will test whether an app-based coaching program, with or without a short low-calorie diet phase, helps adults with type 2 diabetes lose weight and improve self-management over 12 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT07361640 on ClinicalTrials.gov |
What this trial studies
This is a three-armed, parallel-group randomized pilot comparing usual care to an e-health coaching program alone and the same program plus a low-calorie total diet replacement induction phase. Adults with recent-onset type 2 diabetes, BMI >27 kg/m2, and smartphone access will be randomized and followed for 12 months to measure weight change, self-management behaviors, and metabolic risk markers. The DiaMester app provides secure messaging with one of six trained health coaches (dietitians or diabetes nurses) who deliver tailored diet and activity support and monitor progress toward agreed weight targets. The pilot focuses on feasibility and whether the program achieves clinically meaningful weight loss and related metabolic improvements compared with usual care.
Who should consider this trial
Good fit: Adults aged 18 or older with type 2 diabetes of 0–6 years' duration, BMI >27 kg/m2, specified HbA1c levels depending on treatment, a desire to lose weight, stable recent weight, and ownership of a smartphone are ideal candidates.
Not a fit: People using insulin, with recent major weight change or recent start of weight-loss drugs, very high HbA1c, severe kidney impairment (eGFR <30), or active cancer are excluded and may not benefit from this program.
Why it matters
Potential benefit: If successful, the program could help people with early type 2 diabetes achieve substantial weight loss, improve glucose control, and potentially lead to diabetes remission through a scalable app-based coaching model.
How similar studies have performed: Previous trials using structured low-calorie total diet replacement (for example DiRECT) have produced substantial weight loss and diabetes remission in some patients, and digital coaching programs have shown promise though results vary.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Anne-Marie Aas, PhD — Oslo University Hospital and University of Oslo
- Study coordinator: Anne-Marie Aas, PhD
- Email: a.m.aas@medisin.uio.no
- Phone: +47 47302912
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.