The eHealth Diabetes Remission Trial

NCT05491005 · tracked via the Priya Life Science Sweden tracker

Sponsor

Umeå University

Phase

Not applicable

Started

2022-08-31

Last updated

2026-04-30

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Total diet replacementeHealthFace-to-face

Total diet replacement: Total diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months.

eHealth: All follow-up through an eHealth application and video meetings.

Face-to-face: All follow-up through face-to-face meetings.

Study summary

Overweight patients with type 2 diabetes are offered a total diet replacement with the goal of weight loss and diabetes remission. Study participants are randomised to eHealth follow-up or face-to-face follow-up, but the dietary advice is the same in both groups. A healthy control group with normal glucose tolerance is examined once but is not randomised and does not receive any intervention.

Eligibility

Sex

ALL

Min age

20 Years

Max age

70 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Type 2 diabetes with duration 0-6 years * BMI 27 kg/m2 and higher * HbA1c 43 mmol/mol or higher (48 or higher if without diabetes medication) Exclusion Criteria: * Insulin treatment * Weight loss more than 5 kg during the past 6 months * Diagnosed eating disorder * eGFR \< 30 ml/min/1,73m2 * Myocardial infarction last six months * Severe heart failure (NYHA class III) * Ongoing cancer * Pregnancy * Treatment with antipsychotic drugs

Primary outcome measure(s)

HbA1c — 12 months
HbA1c without diabetes medication as a continuous outcome (HbA1c correction according to Tsapas et al 2020 if on diabetes medication). The outcome will be tested for non-inferiority first, with a non-inferiority margin of 8 mmol/mol; followed by a test for superiority.

Trial sites (3)

Facility	City	Region	Status
Bra Liv Råslätt vårdcentral	Jönköping	Sweden	Recruiting
Örnsköldsvik hospital	Örnsköldsvik	Sweden	Not Yet Recruiting
Department of Public Health and Clinical Medicine, Medicine	Umeå	Sweden	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05491005 on ClinicalTrials.gov ↗ ← All trials in Sweden