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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden, 90187
    • Department of Public Health and Clinical Medicine, Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider; This study has only one arm and no comparator.

Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Julia Otten
• Collaborators: Region Västerbotten
• Investigators: Principal Investigator: Julia Otten, MD, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): January 29, 2022
• Study Completion (Actual): January 29, 2022

Study Registration Dates

• First Submitted: March 13, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 29, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: weight loss; eHealth; low-calorie diet; diabetes remission
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: Dnr 2021-00318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No