Skip to main content
OpenTrials
Completed

NCT Number: NCT04805996

The eHealth Diabetes Remission Trial - Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health and Clinical Medicine, Medicine

Umeå, 90187, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Weight loss

    Time frame: 6 months

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

  2. HbA1c

    Time frame: 6 months

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

Secondary outcomes

  1. Semi-structured interviews

    Time frame: 6 months

  2. Fasting blood glucose

    Time frame: Daily measurements up to 6 months

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

  3. Fasting blood glucose

    Time frame: 6 months

    Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.

  4. P-glucose 120 minutes after the oral glucose tolerance test

    Time frame: 6 months

    Measured at the research facilities

  5. Insulin secretion

    Time frame: At baseline, 3 months and 6 months

    Measured with oral glucose tolerance test

  6. Insulin sensitivity

    Time frame: At baseline, 3 months and 6 months

    Measured with oral glucose tolerance test

  7. Metabolic flexibility

    Time frame: At baseline, 3 months and 6 months

    Measured with indirect calorimetry during oral glucose tolerance test

  8. Blood pressure (systolic/diastolic)

    Time frame: At baseline, 3 months and 6 months

    Measured at the research facilities

  9. Blood pressure (systolic/diastolic)

    Time frame: Daily measurements up to 6 months

    Measured at home

  10. Blood pressure medication

    Time frame: 6 months

    Change of blood pressure medication during the study

  11. Body weight

    Time frame: Daily measurements up to 6 months

    Measured at home

  12. HbA1c

    Time frame: Monthly measurement up to 6 months

    Measured at home

  13. Diabetes medication

    Time frame: 6 months

    Change of diabetes medication during study duration

  14. Plasma lipid profile

    Time frame: At baseline, 3 months and 6 months

    Measured at the research facilities

  15. Waist circumference

    Time frame: Baseline, 3 months and 6 months

    Measured in cm at the research facilities

  16. EQ-5D-5L

    Time frame: At baseline, 3 months and 6 months

    Questionnaire

  17. Food frequency form

    Time frame: At baseline and 6 months

    Questionnaire

  18. Daily steps

    Time frame: During the second three months of the study

    Measured with activity tracker

  19. HbA1c follow up

    Time frame: Yearly up to 20 years

    Collected from patient journals after study completion

  20. Body weight follow up

    Time frame: Yearly up to 20 years

    Collected from patient journals after study completion

  21. Blood pressure follow up (systolic/diastolic)

    Time frame: Yearly up to 20 years

    Collected from patient journals after study completion

  22. Antidiabetic medication usage follow up

    Time frame: Yearly up to 20 years

    Collected from patient journals after study completion

  23. Blood pressure medication usage follow up

    Time frame: Yearly up to 20 years

    Collected from patient journals after study completion

  24. Diabetes complications follow up

    Time frame: Yearly up to 20 years

    Collected from patient journals and registries after study completion

Sponsors and collaborators

Lead sponsor

Julia Otten

Other

Collaborators

  • Region Västerbotten

Registry information

Acronym: eDIT-pilot

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.