The eHealth Diabetes Remission Trial
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Total diet replacementBehavioral: eHealthBehavioral: Face-to-face
- Registration Number
- NCT05491005
- Lead Sponsor
- Umeå University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 106
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description eHealth eHealth - eHealth Total diet replacement - Face-to-face Face-to-face - Face-to-face Total diet replacement -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Diabetes remission 6, 12 and 24 months 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.
Achieved weight loss of at least 15 kg 6, 12 and 24 months Number of participants with achieved weight loss of at least 15 kg
Estimated lifetime costs per quality-adjusted life-year (QALY) 24 months Incremental costs per diabetes remission 24 months Study experience 24 months Qualitative questions with written answers about study experience
Estimated lifetime costs 24 months P-glucose 120 minutes after the oral glucose tolerance test 6, 12, 24 months Blood pressure (systolic/diastolic) 6, 12, 24 months Measured at the research facilities
Blood pressure 6, 12, 24 months 24h monitoring
Waist circumference 6, 12, 24 months Body weight follow-up Yearly up to 20 years Collected from patient journals after study completion
Usage of diabetes medication follow-up Yearly up to 20 years Collected from patient journals after study completion
Usage of hypertension medication follow-up Yearly up to 20 years Collected from patient journals after study completion
HbA1c 6 and 24 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.
Body weight 6, 12 and 24 months Body weight as a continuous outcome
Number of prescribed oral anti diabetic medications 6, 12, 24 months Fasting blood glucose 6, 12, 24 months Partial diabetes remission (\<7.0 mol/l), complete diabetes remission (\<6.1 mol/l) without diabetes medication.
Liver enzymes 6, 12, 24 months AST, ALT
Number of participants that discontinue the intervention 6, 12, 24 months Quality of life accoring to Brunnsviken Brief Quality of Life Scale 6, 12, 24 months 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.
Eating habits 6, 12, 24 months FFQ 2020 questionnaire
Number of prescribed antihypertensive medications 6, 12, 24 months Plasma lipid profile 6, 12, 24 months Estimation of exhaustion 6, 12, 24 months Karolinska Exhaustion Disorder Scale. Minimum value 0. Maximum value 54. A higher score means a worse outcome.
Quality of life according to EQ-5D-5L 6, 12, 24 months 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.
Diabetes complications follow-up Yearly up to 20 years Collected from patient journals and registries after study completion
Relation to food 6, 12, 24 months Three factor eating questionnaire
Estimation of health 6, 12, 24 months SF-36 questionnaire
Daily steps 6, 12, 24 months Measured with activity tracker
HbA1c follow-up Yearly up to 20 years Collected from patient journals after study completion
Blood pressure follow-up Yearly up to 20 years Collected from patient journals after study completion
Trial Locations
- Locations (3)
Bra Liv Råslätt vårdcentral
🇸🇪Jönköping, Sweden
Department of Public Health and Clinical Medicine, Medicine
🇸🇪Umeå, Sweden
Örnsköldsvik hospital
🇸🇪Örnsköldsvik, Sweden