The eHealth Diabetes Remission Trial

NCT05491005 | Recruiting

• 1 other identifier: Dnr 2022-02242-01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Remission; Nutrition Therapy; Obesity; eHealth; Weight Loss

Outcome Measures

Primary Outcomes (1)

• HbA1c

  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.

  12 months

Secondary Outcomes (31)

• HbA1c

  6 and 24 months

• Diabetes remission

  6, 12 and 24 months

• Body weight

  6, 12 and 24 months

• Achieved weight loss of at least 15 kg

  6, 12 and 24 months

• Incremental costs per diabetes remission

  24 months

Other Outcomes (24)

• Insulin sensitivity

  12 months

• Insulin secretion

  12 months

• Metabolic flexibility

  12 months

Study Arms (3)

eHealth

EXPERIMENTAL

Behavioral: Total diet replacement; Behavioral: eHealth

Face-to-face

EXPERIMENTAL

Behavioral: Total diet replacement; Behavioral: Face-to-face

Healthy control group

NO INTERVENTION

Interventions

Total diet replacement BEHAVIORAL

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

Face-to-face; eHealth

eHealth BEHAVIORAL

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

eHealth

Face-to-face BEHAVIORAL

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

Face-to-face

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Edgar Sjölunds Diabetes Foundation: collaborator
• Umeå University: lead
• Region Västerbotten: collaborator

Study Sites (3)

Bra Liv Råslätt vårdcentral

Jönköping, Sweden

RECRUITING

Örnsköldsvik hospital

Örnsköldsvik, Sweden

NOT YET RECRUITING

Department of Public Health and Clinical Medicine, Medicine

Umeå, 90187, Sweden

RECRUITING

Related Publications (2)

• Tsapas A, Avgerinos I, Karagiannis T, Malandris K, Manolopoulos A, Andreadis P, Liakos A, Matthews DR, Bekiari E. Comparative Effectiveness of Glucose-Lowering Drugs for Type 2 Diabetes: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2020 Aug 18;173(4):278-286. doi: 10.7326/M20-0864. Epub 2020 Jun 30.

  PMID: 32598218 BACKGROUND

• Otten J, Tellstrom A, Schien C, Chninou Y, Lindholm L, Winkvist A, Liv P, Stomby A. eHealth versus face-to-face support for remission of type 2 diabetes by calorie restriction (eHealth DIabetes remission Trial): study protocol for a non-inferiority parallel group randomised controlled trial. BMJ Open. 2025 Jul 22;15(7):e095100. doi: 10.1136/bmjopen-2024-095100.

  PMID: 40701606 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Weight Loss

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Julia Otten, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Otten, PhD

CONTACT

+46703341559; julia.otten@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: August 31, 2022
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data is available to other researchers as soon as it is published.
• Access Criteria: Data will be shared with other researchers on reasonable request.

Locations

SE (3)