The eHealth Diabetes Remission Trial - Pilot Study

NCT ID: NCT04805996

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2022-01-29

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

This study has only one arm and no comparator.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Västerbotten

OTHER_GOV

Sponsor Role: collaborator

Julia Otten

OTHER

Sponsor Role: lead

Responsible Party

Julia Otten

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Julia Otten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Department of Public Health and Clinical Medicine, Medicine

Umeå, , Sweden

Countries

Sweden

Other Identifiers

Dnr 2021-00318

Identifier Type: -

Identifier Source: org_study_id