The eHealth Diabetes Remission Trial - Pilot Study

Type 2 Diabetes Clinical Trial

— eDIT-pilot  

Official title:

The eHealth Diabetes Remission Trial - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805996
• Other study ID #: Dnr 2021-00318
• Status: Completed
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: January 29, 2022

Study information

• Verified date: January 2022
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 29, 2022
• Est. primary completion date: January 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Public Health and Clinical Medicine, Medicine	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Julia Otten	Västerbotten County Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Weight loss goal of 15 kg, measured at the research facilities	6 months
Primary	HbA1c	The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication. (Secondary goal < 42 mmol/mol.)	6 months
Secondary	Semi-structured interviews		6 months
Secondary	Fasting blood glucose	Partial diabetes remission (< 7.0 mol/l), complete diabetes remission (<6.1 mol/l)	Daily measurements up to 6 months
Secondary	Fasting blood glucose	Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.	6 months
Secondary	P-glucose 120 minutes after the oral glucose tolerance test	Measured at the research facilities	6 months
Secondary	Insulin secretion	Measured with oral glucose tolerance test	At baseline, 3 months and 6 months
Secondary	Insulin sensitivity	Measured with oral glucose tolerance test	At baseline, 3 months and 6 months
Secondary	Metabolic flexibility	Measured with indirect calorimetry during oral glucose tolerance test	At baseline, 3 months and 6 months
Secondary	Blood pressure (systolic/diastolic)	Measured at the research facilities	At baseline, 3 months and 6 months
Secondary	Blood pressure (systolic/diastolic)	Measured at home	Daily measurements up to 6 months
Secondary	Blood pressure medication	Change of blood pressure medication during the study	6 months
Secondary	Body weight	Measured at home	Daily measurements up to 6 months
Secondary	HbA1c	Measured at home	Monthly measurement up to 6 months
Secondary	Diabetes medication	Change of diabetes medication during study duration	6 months
Secondary	Plasma lipid profile	Measured at the research facilities	At baseline, 3 months and 6 months
Secondary	Waist circumference	Measured in cm at the research facilities	Baseline, 3 months and 6 months
Secondary	EQ-5D-5L	Questionnaire	At baseline, 3 months and 6 months
Secondary	Food frequency form	Questionnaire	At baseline and 6 months
Secondary	Daily steps	Measured with activity tracker	During the second three months of the study
Secondary	HbA1c follow up	Collected from patient journals after study completion	Yearly up to 20 years
Secondary	Body weight follow up	Collected from patient journals after study completion	Yearly up to 20 years
Secondary	Blood pressure follow up (systolic/diastolic)	Collected from patient journals after study completion	Yearly up to 20 years
Secondary	Antidiabetic medication usage follow up	Collected from patient journals after study completion	Yearly up to 20 years
Secondary	Blood pressure medication usage follow up	Collected from patient journals after study completion	Yearly up to 20 years
Secondary	Diabetes complications follow up	Collected from patient journals and registries after study completion	Yearly up to 20 years