The eHealth Diabetes Remission Trial - Pilot Study

Julia Otten10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

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

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Weight loss

Weight loss goal of 15 kg, measured at the research facilities

Time frame: 6 months

HbA1c

The goal is diabetes remission with HbA1c \< 48 mmol/mol without any diabetes medication. (Secondary goal \< 42 mmol/mol.)

Time frame: 6 months

Secondary Outcomes

Semi-structured interviews

Time frame: 6 months

Fasting blood glucose

Partial diabetes remission (\< 7.0 mol/l), complete diabetes remission (\<6.1 mol/l)

Time frame: 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.

Time frame: 6 months

P-glucose 120 minutes after the oral glucose tolerance test

Measured at the research facilities

Time frame: 6 months

Insulin secretion

Measured with oral glucose tolerance test

Time frame: At baseline, 3 months and 6 months

Insulin sensitivity

Measured with oral glucose tolerance test

Time frame: At baseline, 3 months and 6 months

Metabolic flexibility

Measured with indirect calorimetry during oral glucose tolerance test

Time frame: At baseline, 3 months and 6 months

Blood pressure (systolic/diastolic)

Measured at the research facilities

Time frame: At baseline, 3 months and 6 months

Blood pressure (systolic/diastolic)

Measured at home

Time frame: Daily measurements up to 6 months

Blood pressure medication

Change of blood pressure medication during the study

Time frame: 6 months

Body weight

Measured at home

Time frame: Daily measurements up to 6 months

HbA1c

Measured at home

Time frame: Monthly measurement up to 6 months

Diabetes medication

Change of diabetes medication during study duration

Time frame: 6 months

Plasma lipid profile

Measured at the research facilities

Time frame: At baseline, 3 months and 6 months

Waist circumference

Measured in cm at the research facilities

Time frame: Baseline, 3 months and 6 months

EQ-5D-5L

Questionnaire

Time frame: At baseline, 3 months and 6 months

Food frequency form

Questionnaire

Time frame: At baseline and 6 months

Daily steps

Measured with activity tracker

Time frame: During the second three months of the study

HbA1c follow up

Collected from patient journals after study completion