eDIT-pilot: The eHealth Diabetes Remission Trial - Pilot Study

• Sponsor: Julia Otten (Other)
• Overall Status: Completed
• CT.gov ID: NCT04805996
• Collaborator: Region Västerbotten (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Behavioral: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The eHealth Diabetes Remission Trial - Pilot Study
• Actual Study Start Date: Mar 23, 2021
• Actual Primary Completion Date: Jan 29, 2022
• Actual Study Completion Date: Jan 29, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Weight loss [6 months]

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

2. HbA1c [6 months]

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

Secondary Outcome Measures

1. Semi-structured interviews [6 months]

2. Fasting blood glucose [Daily measurements up to 6 months]

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

3. Fasting blood glucose [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 [6 months]

   Measured at the research facilities

5. Insulin secretion [At baseline, 3 months and 6 months]

   Measured with oral glucose tolerance test

6. Insulin sensitivity [At baseline, 3 months and 6 months]

   Measured with oral glucose tolerance test

7. Metabolic flexibility [At baseline, 3 months and 6 months]

   Measured with indirect calorimetry during oral glucose tolerance test

8. Blood pressure (systolic/diastolic) [At baseline, 3 months and 6 months]

   Measured at the research facilities

9. Blood pressure (systolic/diastolic) [Daily measurements up to 6 months]

   Measured at home

10. Blood pressure medication [6 months]

    Change of blood pressure medication during the study

11. Body weight [Daily measurements up to 6 months]

    Measured at home

12. HbA1c [Monthly measurement up to 6 months]

    Measured at home

13. Diabetes medication [6 months]

    Change of diabetes medication during study duration

14. Plasma lipid profile [At baseline, 3 months and 6 months]

    Measured at the research facilities

15. Waist circumference [Baseline, 3 months and 6 months]

    Measured in cm at the research facilities

16. EQ-5D-5L [At baseline, 3 months and 6 months]

    Questionnaire

17. Food frequency form [At baseline and 6 months]

    Questionnaire

18. Daily steps [During the second three months of the study]

    Measured with activity tracker

19. HbA1c follow up [Yearly up to 20 years]

    Collected from patient journals after study completion

20. Body weight follow up [Yearly up to 20 years]

    Collected from patient journals after study completion

21. Blood pressure follow up (systolic/diastolic) [Yearly up to 20 years]

    Collected from patient journals after study completion

22. Antidiabetic medication usage follow up [Yearly up to 20 years]

    Collected from patient journals after study completion

23. Blood pressure medication usage follow up [Yearly up to 20 years]

    Collected from patient journals after study completion

24. Diabetes complications follow up [Yearly up to 20 years]

    Collected from patient journals and registries after study completion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Public Health and Clinical Medicine, Medicine	Umeå		Sweden	90187

Sponsors and Collaborators

• Julia Otten
• Region Västerbotten

Investigators

• Principal Investigator: Julia Otten, MD, PhD, Umeå University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julia Otten, MD, PhD, Umeå University
• ClinicalTrials.gov Identifier: NCT04805996
• Other Study ID Numbers: Dnr 2021-00318
• First Posted: Mar 18, 2021
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Julia Otten, MD, PhD, Umeå University: diabetes remission; weight loss; low-calorie diet; eHealth
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Feb 1, 2022