Clinical trial NCT04805996: The eHealth Diabetes Remission Trial - Pilot Study
Official title: The eHealth Diabetes Remission Trial - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes remission
weight loss
low-calorie diet
eHealth
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
First posted: 2021-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight loss
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Semi-structured interviews
timeFrame: 6 months
measure: Fasting blood glucose
timeFrame: Daily measurements up to 6 months
measure: Fasting blood glucose
timeFrame: 6 months
measure: P-glucose 120 minutes after the oral glucose tolerance test
timeFrame: 6 months
measure: Insulin secretion
timeFrame: At baseline, 3 months and 6 months
measure: Insulin sensitivity
timeFrame: At baseline, 3 months and 6 months
measure: Metabolic flexibility
timeFrame: At baseline, 3 months and 6 months
measure: Blood pressure (systolic/diastolic)
timeFrame: At baseline, 3 months and 6 months
measure: Blood pressure (systolic/diastolic)
timeFrame: Daily measurements up to 6 months
measure: Blood pressure medication
timeFrame: 6 months
measure: Body weight
timeFrame: Daily measurements up to 6 months
measure: HbA1c
timeFrame: Monthly measurement up to 6 months
measure: Diabetes medication
timeFrame: 6 months
measure: Plasma lipid profile
timeFrame: At baseline, 3 months and 6 months
measure: Waist circumference
timeFrame: Baseline, 3 months and 6 months
measure: EQ-5D-5L
timeFrame: At baseline, 3 months and 6 months
measure: Food frequency form
timeFrame: At baseline and 6 months
measure: Daily steps
timeFrame: During the second three months of the study
measure: HbA1c follow up
timeFrame: Yearly up to 20 years
measure: Body weight follow up
timeFrame: Yearly up to 20 years
measure: Blood pressure follow up (systolic/diastolic)
timeFrame: Yearly up to 20 years
measure: Antidiabetic medication usage follow up
timeFrame: Yearly up to 20 years
measure: Blood pressure medication usage follow up
timeFrame: Yearly up to 20 years
measure: Diabetes complications follow up
timeFrame: Yearly up to 20 years
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Public Health and Clinical Medicine, Medicine
Study officials:
affiliation: Umeå University
name: Julia Otten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: