The eHealth Diabetes Remission Trial - Pilot Study

Study Overview
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Brief Summary
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Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c < 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended. The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.

Official Title
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The eHealth Diabetes Remission Trial - Pilot Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes with diabetes duration 0 to 6 years BMI 27-45 kg/m2 Owning a smartphone HbA1c 43-107 mmol/mol during the past 12 months (48-107 mmol/mol without blood sugar lowering medication) Exclusion Criteria: Insulin treatment Weight loss 5 kg or more during the past 6 months Treatment with weight loss medication Diagnosed eating disorder eGFR < 30 ml/min/1.73m2 Substance abuse Cancer Myocardial infarction during the past 6 months Severe heart failure Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider<br>This study has only one arm and no comparator. | Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider<br>* Participants will replace usual foods with the commercially available total diet replacement Modifast (Impolin AB), which is delivered to them during the study period without any cost. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor and will be advised to measure body weight, fasting blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring (Telia Sweden AB) and are wirelessly transmitted to the study team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight loss goal of 15 kg, measured at the research facilities | 6 months | 
| HbA1c | The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication. (Secondary goal < 42 mmol/mol.) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-structured interviews |  | 6 months | 
| Fasting blood glucose | Partial diabetes remission (< 7.0 mol/l), complete diabetes remission (<6.1 mol/l) | Daily measurements up to 6 months | 
| Fasting blood glucose | Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication. | 6 months | 
| P-glucose 120 minutes after the oral glucose tolerance test | Measured at the research facilities | 6 months | 
| Insulin secretion | Measured with oral glucose tolerance test | At baseline, 3 months and 6 months | 
| Insulin sensitivity | Measured with oral glucose tolerance test | At baseline, 3 months and 6 months | 
| Metabolic flexibility | Measured with indirect calorimetry during oral glucose tolerance test | At baseline, 3 months and 6 months | 
| Blood pressure (systolic/diastolic) | Measured at the research facilities | At baseline, 3 months and 6 months | 
| Blood pressure (systolic/diastolic) | Measured at home | Daily measurements up to 6 months | 
| Blood pressure medication | Change of blood pressure medication during the study | 6 months | 
| Body weight | Measured at home | Daily measurements up to 6 months | 
| HbA1c | Measured at home | Monthly measurement up to 6 months | 
| Diabetes medication | Change of diabetes medication during study duration | 6 months | 
| Plasma lipid profile | Measured at the research facilities | At baseline, 3 months and 6 months | 
| Waist circumference | Measured in cm at the research facilities | Baseline, 3 months and 6 months | 
| EQ-5D-5L | Questionnaire | At baseline, 3 months and 6 months | 
| Food frequency form | Questionnaire | At baseline and 6 months | 
| Daily steps | Measured with activity tracker | During the second three months of the study | 
| HbA1c follow up | Collected from patient journals after study completion | Yearly up to 20 years | 
| Body weight follow up | Collected from patient journals after study completion | Yearly up to 20 years | 
| Blood pressure follow up (systolic/diastolic) | Collected from patient journals after study completion | Yearly up to 20 years | 
| Antidiabetic medication usage follow up | Collected from patient journals after study completion | Yearly up to 20 years | 
| Blood pressure medication usage follow up | Collected from patient journals after study completion | Yearly up to 20 years | 
| Diabetes complications follow up | Collected from patient journals and registries after study completion | Yearly up to 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes remission, weight loss, low-calorie diet, eHealth