The eHealth Diabetes Remission Trial - Pilot Study (eDIT-pilot)

Julia Otten

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider

Study type: Interventional

Funder types: Other

Identifiers

NCT04805996

Dnr 2021-00318

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Diabetes remission using total diet replacement and eHealth contact with the healthcare provider

Experimental group

Description:

This study has only one arm and no comparator.

Treatment:

Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider