The eHealth Diabetes Remission Trial - Pilot Study
- Conditions
- Type 2 Diabetes
- Interventions
- Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
- Registration Number
- NCT04805996
- Lead Sponsor
- Julia Otten
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diabetes remission using total diet replacement and eHealth contact with the healthcare provider Diabetes remission using total diet replacement and eHealth contact with the healthcare provider This study has only one arm and no comparator.
- Primary Outcome Measures
Name Time Method Weight loss 6 months Weight loss goal of 15 kg, measured at the research facilities
HbA1c 6 months The goal is diabetes remission with HbA1c \< 48 mmol/mol without any diabetes medication. (Secondary goal \< 42 mmol/mol.)
- Secondary Outcome Measures
Name Time Method Diabetes medication 6 months Change of diabetes medication during study duration
Insulin sensitivity At baseline, 3 months and 6 months Measured with oral glucose tolerance test
Blood pressure (systolic/diastolic) Daily measurements up to 6 months Measured at home
Insulin secretion At baseline, 3 months and 6 months Measured with oral glucose tolerance test
Fasting blood glucose 6 months Partial diabetes remission (\<7.0 mol/l), complete diabetes remission (\<6.1 mol/l) without diabetes medication.
P-glucose 120 minutes after the oral glucose tolerance test 6 months Measured at the research facilities
EQ-5D-5L At baseline, 3 months and 6 months Questionnaire
Food frequency form At baseline and 6 months Questionnaire
Antidiabetic medication usage follow up Yearly up to 20 years Collected from patient journals after study completion
Blood pressure medication usage follow up Yearly up to 20 years Collected from patient journals after study completion
Semi-structured interviews 6 months Metabolic flexibility At baseline, 3 months and 6 months Measured with indirect calorimetry during oral glucose tolerance test
Blood pressure medication 6 months Change of blood pressure medication during the study
Daily steps During the second three months of the study Measured with activity tracker
Diabetes complications follow up Yearly up to 20 years Collected from patient journals and registries after study completion
Body weight Daily measurements up to 6 months Measured at home
HbA1c Monthly measurement up to 6 months Measured at home
Blood pressure follow up (systolic/diastolic) Yearly up to 20 years Collected from patient journals after study completion
Plasma lipid profile At baseline, 3 months and 6 months Measured at the research facilities
HbA1c follow up Yearly up to 20 years Collected from patient journals after study completion
Body weight follow up Yearly up to 20 years Collected from patient journals after study completion
Waist circumference Baseline, 3 months and 6 months Measured in cm at the research facilities
Trial Locations
- Locations (1)
Department of Public Health and Clinical Medicine, Medicine
šøšŖUmeĆ„, Sweden