The eHealth Diabetes Remission Trial - Pilot Study

NCT04805996 | Completed

• 1 other identifier: Dnr 2021-00318
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

diabetes remission; weight loss; low-calorie diet; eHealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• Semi-structured interviews

  6 months

• Fasting blood glucose

  Daily measurements up to 6 months

• Fasting blood glucose

  6 months

• P-glucose 120 minutes after the oral glucose tolerance test

  6 months

• Insulin secretion

  At baseline, 3 months and 6 months

Study Arms (1)

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

EXPERIMENTAL

This study has only one arm and no comparator.

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

Interventions

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

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

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Julia Otten: lead
• Region Västerbotten: collaborator

Study Sites (1)

Department of Public Health and Clinical Medicine, Medicine

Umeå, 90187, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Weight Loss

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Otten, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 18, 2021
• Study Start: March 23, 2021
• Primary Completion: January 29, 2022
• Study Completion: January 29, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)