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

NCT07361640 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-01-23

No results posted yet for this study

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).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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.

Sponsors & Collaborators

  • University of Tromso

    collaborator OTHER

  • Abel Technologies AS

    collaborator UNKNOWN

  • The Dam Foundation

    collaborator OTHER

  • Diabetes Wellness Norway

    collaborator UNKNOWN

  • Norwegian Diabetes Association

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Anne-Marie Aas, PhD · Oslo University Hospital and University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07361640 on ClinicalTrials.gov