Diabetes Mellitus, Type 2eDITNCT05491005
The eHealth Diabetes Remission Trial
A study testing Total diet replacement, eHealth and Face-to-face in people with Diabetes Mellitus, Type 2, run by Umeå University at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Total diet replacement, eHealth and Face-to-face
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 3 sitesSweden
- Study dates
- 31 Aug 2022to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 9Show fewer
- Ongoing cancer
- Pregnancy
- Treatment with antipsychotic drugs
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Bra Liv Råslätt vårdcentral
Jönköping
Andreas Stomby, PhD
- Not yet recruiting
Örnsköldsvik hospital
Örnsköldsvik
Katarina Shahedi, MD
- Recruiting
Department of Public Health and Clinical Medicine, Medicine
Umeå, 90187
Julia Otten, MD, PhD
Julia Otten, MD, PhD
About this study
Official title: eHealth Diabetes Remission Trial (Swedish: Remission av Typ 2 Diabetes Med hjälp av eHälsa
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.
Read the detailed description
One hundred and six overweight patients with type 2 diabetes replace usual foods with total diet replacement (850 kcal/day) for 3 months with the goal of 15 kg weight loss and diabetes remission (HbA1c < 48 mmol/mol without diabetes medication). After 3 months of total diet replacement, food is reintroduced stepwise, and an individually tailored energy prescription is used to prevent weight regain. If study participants do not reach the weight loss goal at 3 months, they are recommended two additional months of total diet replacement. If weight regain occurs during the weight maintenance phase, a rescue plan with total diet replacement will be recommended. To increase the chances to maintain their lower body weight, participants will use a program specifically design for that purpose based on cognitive behavioural therapy. Total study duration is two years.
The one hundred and six participants are randomised to either the eHealth follow-up or the face-to-face follow-up. The dietary advice to achieve and maintain weight loss is the same in both groups and delivered by the same dietician, physician, and nurse but the method of follow-up differs between groups (eHealth vs face-to-face).
eHealth group:
All study information and the cognitive behavioural therapy program is given by an eHealth application in Stöd och behandling which is part of 1177.se. Participants register body weight, fasting blood glucose, and blood pressure every morning at 1177.se. Regularly a measurement of HbA1c is taken at home. Participants will have scheduled video appointments with the study dietician, study nurse or study physician.
Face-to-face group:
Participants have appointments in the medical office with the study physician/nurse/dietician. At the appointments, body weight, blood pressure and capillary blood glucose is measured. HbA1c is measured during the appointments at 0, 6, 12 and 24 months. The cognitive behavioral therapy program for the control group is identical to the program of the intervention group, but the program is delivered during the face-to-face appointments.
Healthy control group:
Fifteen healthy participants with normal glucose tolerance, stable body weight for at least one year and matched to the study participants for sex, age, and weight after one year study duration, will be examined once. These participants are not randomised and do not receive any intervention.
Outcomes:
Primary and secondary outcome measures are compared between 1) the experimental eHealth group and 2) the experimental face-to-face group. For the other pre-specified outcome measures the experimental eHealth group and the experimental face-to-face group are taken together as one group, examined twice (baseline and 12 months) and compared to the healthy control group, that is examined only once.
Long-term follow-up:
Because long term data on diabetes remission by total diet replacement are lacking, study participants will be followed after they have finished the study. Data of the national diabetes registry from participants of this study will be compared to other patients in the national diabetes registry not participating in this study but matched for age, sex and diabetes duration to the study participants.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Total diet replacement, eHealth, Face-to-face
- Keywords
- Diabetes Remission, Nutrition Therapy, Obesity, eHealth, Weight Loss
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total diet replacementBehavioural
Total diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months.
eHealthBehavioural
All follow-up through an eHealth application and video meetings.
Face-to-faceBehavioural
All follow-up through face-to-face meetings.
| Study group | Role | What they receive |
|---|---|---|
| eHealth | Experimental | Not described Receives: Behavioral: Total diet replacement; Behavioral: eHealth |
| Face-to-face | Experimental | Not described Receives: Behavioral: Total diet replacement; Behavioral: Face-to-face |
| Healthy control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (31)
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.
Measured: 6 and 24 months
Diabetes remission
Number of participants with HbA1c < 48 mmol/mol without diabetes medication. The outcome will be tested for non-inferiority first with a non-inferiority margin of 10 percentage points; followed by a test for superiority.
Measured: 6, 12 and 24 months
Body weight
Body weight as a continuous outcome
Measured: 6, 12 and 24 months
Achieved weight loss of at least 15 kg
Number of participants with achieved weight loss of at least 15 kg
Measured: 6, 12 and 24 months
Incremental costs per diabetes remission
Measured: 24 months
Estimated lifetime costs
Measured: 24 months
Estimated lifetime costs per quality-adjusted life-year (QALY)
Measured: 24 months
Fasting blood glucose
Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.
Measured: 6, 12, 24 months
P-glucose 120 minutes after the oral glucose tolerance test
Measured: 6, 12, 24 months
Number of prescribed oral anti diabetic medications
Measured: 6, 12, 24 months
Number of prescribed antihypertensive medications
Measured: 6, 12, 24 months
Blood pressure (systolic/diastolic)
Measured at the research facilities
Measured: 6, 12, 24 months
Blood pressure
24h monitoring
Measured: 6, 12, 24 months
Plasma lipid profile
Measured: 6, 12, 24 months
Liver enzymes
AST, ALT
Measured: 6, 12, 24 months
Number of participants that discontinue the intervention
Measured: 6, 12, 24 months
Waist circumference
Measured: 6, 12, 24 months
Relation to food
Three factor eating questionnaire
Measured: 6, 12, 24 months
Estimation of exhaustion
Karolinska Exhaustion Disorder Scale. Minimum value 0. Maximum value 54. A higher score means a worse outcome.
Measured: 6, 12, 24 months
Quality of life accoring to Brunnsviken Brief Quality of Life Scale
The scale estimates how satisfied the participants is with different areas of life, as well as how important each area of life is. Minimum scale 0. Maximum scale 48. A higher score means a better outcome.
Measured: 6, 12, 24 months
Quality of life according to EQ-5D-5L
The questionnaire investigates the dimensions mobility, self-care, usual activities, pain and anxiety/depression. Minimum value 1. Maximum value 5. A higher score means a worse outcome. In addition, a general health score is assessed. Minimum value 0. Maximum value 100. A higher score means a better outcome. All dimension will be analysed separately, but EQ-5D-5L will also be combined to one score.
Measured: 6, 12, 24 months
Eating habits
FFQ 2020 questionnaire
Measured: 6, 12, 24 months
Estimation of health
SF-36 questionnaire
Measured: 6, 12, 24 months
Daily steps
Measured with activity tracker
Measured: 6, 12, 24 months
Study experience
Qualitative questions with written answers about study experience
Measured: 24 months
HbA1c follow-up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Body weight follow-up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Blood pressure follow-up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Usage of diabetes medication follow-up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Usage of hypertension medication follow-up
Collected from patient journals after study completion
Measured: Yearly up to 20 years
Diabetes complications follow-up
Collected from patient journals and registries after study completion
Measured: Yearly up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start31 Aug 2022
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten, Edgar Sjölunds Diabetes Foundation
- Responsible party
- Principal investigator, Julia Otten, Umeå University
- Investigators
- Julia Otten, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491005
- Sponsor's protocol ID
- Dnr 2022-02242-01
- Acronym
- eDIT
- Status last verified
- Apr 2026
- First submitted
- 3 Aug 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other researchers on reasonable request.
Publications
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.
PubMed 32598218Gladzki L, Brunstrom M, Otten J. Reduced antihypertensive treatment with maintained ambulatory blood pressure control following weight loss in type 2 diabetes. Blood Press. 2026 Dec;35(1):2676362. doi: 10.1080/08037051.2026.2676362. Epub 2026 Jun 5.
PubMed 42154590Otten 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.
PubMed 40701606
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eHealth Diabetes Remission Trial (Swedish: Remission av Typ 2 Diabetes Med hjälp av eHälsa
- ClinicalTrials.gov ID
- NCT05491005
- Acronym / sponsor ID
- eDIT / Dnr 2022-02242-01
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Remission, Nutrition Therapy, Obesity, eHealth, Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten, Edgar Sjölunds Diabetes Foundation
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One hundred and six overweight patients with type 2 diabetes replace usual foods with total diet replacement (850 kcal/day) for 3 months with the goal of 15 kg weight loss and diabetes remission (HbA1c < 48 mmol/mol without diabetes medication). After 3 months of total diet replacement, food is reintroduced stepwise, and an individually tailored energy prescription is used to prevent weight regain. If study participants do not reach the weight loss goal at 3 months, they are recommended two additional months of total diet replacement. If weight regain occurs during the weight maintenance phase, a rescue plan with total diet replacement will be recommended. To increase the chances to maintain their lower body weight, participants will use a program specifically design for that purpose based on cognitive behavioural therapy. Total study duration is two years.
The one hundred and six participants are randomised to either the eHealth follow-up or the face-to-face follow-up. The dietary advice to achieve and maintain weight loss is the same in both groups and delivered by the same dietician, physician, and nurse but the method of follow-up differs between groups (eHealth vs face-to-face).
eHealth group:
All study information and the cognitive behavioural therapy program is given by an eHealth application in Stöd och behandling which is part of 1177.se. Participants register body weight, fasting blood glucose, and blood pressure every morning at 1177.se. Regularly a measurement of HbA1c is taken at home. Participants will have scheduled video appointments with the study dietician, study nurse or study physician.
Face-to-face group:
Participants have appointments in the medical office with the study physician/nurse/dietician. At the appointments, body weight, blood pressure and capillary blood glucose is measured. HbA1c is measured during the appointments at 0, 6, 12 and 24 months. The cognitive behavioral therapy program for the control group is identical to the program of the intervention group, but the program is delivered during the face-to-face appointments.
Healthy control group:
Fifteen healthy participants with normal glucose tolerance, stable body weight for at least one year and matched to the study participants for sex, age, and weight after one year study duration, will be examined once. These participants are not randomised and do not receive any intervention.
Outcomes:
Primary and secondary outcome measures are compared between 1) the experimental eHealth group and 2) the experimental face-to-face group. For the other pre-specified outcome measures the experimental eHealth group and the experimental face-to-face group are taken together as one group, examined twice (baseline and 12 months) and compared to the healthy control group, that is examined only once.
Long-term follow-up:
Because long term data on diabetes remission by total diet replacement are lacking, study participants will be followed after they have finished the study. Data of the national diabetes registry from participants of this study will be compared to other patients in the national diabetes registry not participating in this study but matched for age, sex and diabetes duration to the study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total diet replacementTotal diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months. | Behavioural | Face-to-face, eHealth |
| eHealthAll follow-up through an eHealth application and video meetings. | Behavioural | eHealth |
| Face-to-faceAll follow-up through face-to-face meetings. | Behavioural | Face-to-face |
Primary outcome
HbA1c
Time frame: 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.
31 secondary outcomes
HbA1c
Time frame: 6 and 24 months
Diabetes remission
Time frame: 6, 12 and 24 months
Body weight
Time frame: 6, 12 and 24 months
Achieved weight loss of at least 15 kg
Time frame: 6, 12 and 24 months
Incremental costs per diabetes remission
Time frame: 24 months
Estimated lifetime costs
Time frame: 24 months
Estimated lifetime costs per quality-adjusted life-year (QALY)
Time frame: 24 months
Fasting blood glucose
Time frame: 6, 12, 24 months
P-glucose 120 minutes after the oral glucose tolerance test
Time frame: 6, 12, 24 months
Number of prescribed oral anti diabetic medications
Time frame: 6, 12, 24 months
Number of prescribed antihypertensive medications
Time frame: 6, 12, 24 months
Blood pressure (systolic/diastolic)
Time frame: 6, 12, 24 months
Blood pressure
Time frame: 6, 12, 24 months
Plasma lipid profile
Time frame: 6, 12, 24 months
Liver enzymes
Time frame: 6, 12, 24 months
Number of participants that discontinue the intervention
Time frame: 6, 12, 24 months
Waist circumference
Time frame: 6, 12, 24 months
Relation to food
Time frame: 6, 12, 24 months
Estimation of exhaustion
Time frame: 6, 12, 24 months
Quality of life accoring to Brunnsviken Brief Quality of Life Scale
Time frame: 6, 12, 24 months
Quality of life according to EQ-5D-5L
Time frame: 6, 12, 24 months
Eating habits
Time frame: 6, 12, 24 months
Estimation of health
Time frame: 6, 12, 24 months
Daily steps
Time frame: 6, 12, 24 months
Study experience
Time frame: 24 months
HbA1c follow-up
Time frame: Yearly up to 20 years
Body weight follow-up
Time frame: Yearly up to 20 years
Blood pressure follow-up
Time frame: Yearly up to 20 years
Usage of diabetes medication follow-up
Time frame: Yearly up to 20 years
Usage of hypertension medication follow-up
Time frame: Yearly up to 20 years
Diabetes complications follow-up
Time frame: Yearly up to 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 32598218Tsapas 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.
- Derived from this study: PubMed 42154590Gladzki L, Brunstrom M, Otten J. Reduced antihypertensive treatment with maintained ambulatory blood pressure control following weight loss in type 2 diabetes. Blood Press. 2026 Dec;35(1):2676362. doi: 10.1080/08037051.2026.2676362. Epub 2026 Jun 5.
- Derived from this study: PubMed 40701606Otten 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.
- Individual participant dataSharing planned: Yes. Data will be shared with other researchers on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Otten, PhD principal investigator
Umeå University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total diet replacement, eHealth and Face-to-face in people with Diabetes Mellitus, Type 2, run by Umeå University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Otten, PhD (+46703341559, julia.otten@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05491005, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.