The eHealth Diabetes Remission Trial

Diabetes Mellitus, Type 2 Clinical Trial

— eDIT  

Official title:

eHealth Diabetes Remission Trial (Swedish: Remission av Typ 2 Diabetes Med hjälp av eHälsa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491005
• Other study ID #: Dnr 2022-02242-01
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Umeå University
• Contact: Julia Otten, PhD
• Phone: +46703341559
• Email: julia.otten[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Overweight patients with type 2 diabetes are offered a total diet replacement with the goal of weight loss and diabetes remission. Study participants are randomised to eHealth follow-up or face-to-face follow-up, but the dietary advice is the same in both groups. A healthy control group with normal glucose tolerance is examined once but is not randomised and does not receive any intervention.

Description:

One hundred and six overweight patients with type 2 diabetes replace usual foods with total diet replacement (850 kcal/day) for 3 months with the goal of 15 kg weight loss and diabetes remission (HbA1c < 48 mmol/mol without diabetes medication). After 3 months of total diet replacement, food is reintroduced stepwise, and an individually tailored energy prescription is used to prevent weight regain. If study participants do not reach the weight loss goal at 3 months, they are recommended two additional months of total diet replacement. If weight regain occurs during the weight maintenance phase, a rescue plan with total diet replacement will be recommended. To increase the chances to maintain their lower body weight, participants will use a program specifically design for that purpose based on cognitive behavioural therapy. Total study duration is two years. The one hundred and six participants are randomised to either the eHealth follow-up or the face-to-face follow-up. The dietary advice to achieve and maintain weight loss is the same in both groups and delivered by the same dietician, physician, and nurse but the method of follow-up differs between groups (eHealth vs face-to-face). eHealth group: All study information and the cognitive behavioural therapy program is given by an eHealth application in Stöd och behandling which is part of 1177.se. Participants register body weight, fasting blood glucose, and blood pressure every morning at 1177.se. Regularly a measurement of HbA1c is taken at home. Participants will have scheduled video appointments with the study dietician, study nurse or study physician. Face-to-face group: Participants have appointments in the medical office with the study physician/nurse/dietician. At the appointments, body weight, blood pressure and capillary blood glucose is measured. HbA1c is measured during the appointments at 0, 6, 12 and 24 months. The cognitive behavioral therapy program for the control group is identical to the program of the intervention group, but the program is delivered during the face-to-face appointments. Healthy control group: Fifteen healthy participants with normal glucose tolerance, stable body weight for at least one year and matched to the study participants for sex, age, and weight after one year study duration, will be examined once. These participants are not randomised and do not receive any intervention. Outcomes: Primary and secondary outcome measures are compared between 1) the experimental eHealth group and 2) the experimental face-to-face group. For the other pre-specified outcome measures the experimental eHealth group and the experimental face-to-face group are taken together as one group, examined twice (baseline and 12 months) and compared to the healthy control group, that is examined only once. Long-term follow-up: Because long term data on diabetes remission by total diet replacement are lacking, study participants will be followed after they have finished the study. Data of the national diabetes registry from participants of this study will be compared to other patients in the national diabetes registry not participating in this study but matched for age, sex and diabetes duration to the study participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes with duration 0-6 years
• BMI 27 kg/m2 and higher
• HbA1c 43 mmol/mol or higher (48 or higher if without diabetes medication)

Exclusion Criteria:

• Insulin treatment
• Weight loss more than 5 kg during the past 6 months
• Diagnosed eating disorder
• eGFR < 30 ml/min/1,73m2
• Myocardial infarction last six months
• Severe heart failure (NYHA class III)
• Ongoing cancer
• Pregnancy
• Treatment with antipsychotic drugs

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Total diet replacement
Total diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months.
• eHealth
All follow-up through an eHealth application and video meetings.
• Face-to-face
All follow-up through face-to-face meetings.

Locations

Country	Name	City	State
Sweden	Bra Liv Råslätt vårdcentral	Jönköping
Sweden	Örnsköldsvik hospital	Örnsköldsvik
Sweden	Department of Public Health and Clinical Medicine, Medicine	Umeå

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	Edgar Sjölunds Diabetes Foundation, Region Västerbotten

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Tsapas A, Avgerinos I, Karagiannis T, Malandris K, Manolopoulos A, Andreadis P, Liakos A, Matthews DR, Bekiari E. Comparative Effectiveness of Glucose-Lowering Drugs for Type 2 Diabetes: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2020 Aug 18;173(4):278-286. doi: 10.7326/M20-0864. Epub 2020 Jun 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin sensitivity	Hyperinsulinemic euglycemic clamp	12 months
Other	Insulin secretion	Stepped insulin secretion test with arginine	12 months
Other	Metabolic flexibility	Hyperinsulinemic euglycemic clamp	12 months
Other	Resting metabolic rate	Indirect calorimetry	12 months
Other	Body composition	Dual-energy X-ray absorptiometry (DXA).	12 months
Other	Glucagon sensitivity	Plasma amino acids are measured during 120 minutes after a intravenous glucagon bolus	12 months
Other	Amino acid tolerance	Plasma amino acids are measured during intravenous amino acid infusion	12 months
Other	Glucagon secretion capacity	Plasma glucagon is measured during intravenous amino acid infusion	12 months
Other	Gut hormones after carbohydrate intake	GLP-1, GIP and gherkin during the oral glucose tolerance test	6, 12, 24 months
Other	P-metabolites and P-lipids after carbohydrate intake	Metabolomics and lipidomics analyses during the oral glucose tolerance test	6, 12, 24 months
Other	Liver fat	Measured with MRI	12 months
Other	Pancreas fat	Measured with MRI	12 months
Other	Fat cell size in subcutaneous fat		12 months
Other	RNA levels in subcutaneous fat	RNA sequencing	12 months
Other	Secretion of adipokines, metabolites and lipids in subcutaneous fat cells ex vivo		12 months
Other	Plasma testosterone levels	Only men	6, 12 and 24 months
Other	Erectile function	Only men, Erectile function subscale	6, 12, 24 months
Other	Prostate symptoms	Only men, International prostate symptom score	6, 12, 24 months
Other	Urine albumin to creatinine ratio		6, 12, 24 months
Other	Slow vital capacity (SVC)	Spirometry	12 months
Other	Forced vital capacity (FVC)	Spirometry	12 months
Other	Forced expiratory volume in 1 s (FEV1)	Spirometry	12 months
Other	Diffusion capacity of the the (DCLO)	Spirometry	12 months
Other	Troponin T		6, 12 and 24 months
Other	proBNP		6, 12 and 24 months
Primary	HbA1c	HbA1c without diabetes medication as a continuous outcome (HbA1c correction according to Tsapas et al 2020 if on diabetes medication). The outcome will be tested for non-inferiority first, with a non-inferiority margin of 8 mmol/mol; followed by a test for superiority.	12 months
Secondary	HbA1c	HbA1c without diabetes medication as a continuous outcome (HbA1c correction according to Tsapas et al 2020 if on diabetes medication). The outcome will be tested for non-inferiority first, with a non-inferiority margin of 8 mmol/mol; followed by a test for superiority.	6 and 24 months
Secondary	Diabetes remission	Number of participants with HbA1c < 48 mmol/mol without diabetes medication. The outcome will be tested for non-inferiority first with a non-inferiority margin of 10 percentage points; followed by a test for superiority.	6, 12 and 24 months
Secondary	Body weight	Body weight as a continuous outcome	6, 12 and 24 months
Secondary	Achieved weight loss of at least 15 kg	Number of participants with achieved weight loss of at least 15 kg	6, 12 and 24 months
Secondary	Incremental costs per diabetes remission		24 months
Secondary	Estimated lifetime costs		24 months
Secondary	Estimated lifetime costs per quality-adjusted life-year (QALY)		24 months
Secondary	Fasting blood glucose	Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.	6, 12, 24 months
Secondary	P-glucose 120 minutes after the oral glucose tolerance test		6, 12, 24 months
Secondary	Number of prescribed oral anti diabetic medications		6, 12, 24 months
Secondary	Number of prescribed antihypertensive medications		6, 12, 24 months
Secondary	Blood pressure (systolic/diastolic)	Measured at the research facilities	6, 12, 24 months
Secondary	Blood pressure	24h monitoring	6, 12, 24 months
Secondary	Plasma lipid profile		6, 12, 24 months
Secondary	Liver enzymes	AST, ALT	6, 12, 24 months
Secondary	Number of participants that discontinue the intervention		6, 12, 24 months
Secondary	Waist circumference		6, 12, 24 months
Secondary	Relation to food	Three factor eating questionnaire	6, 12, 24 months
Secondary	Estimation of exhaustion	Karolinska Exhaustion Disorder Scale. Minimum value 0. Maximum value 54. A higher score means a worse outcome.	6, 12, 24 months
Secondary	Quality of life accoring to Brunnsviken Brief Quality of Life Scale	The scale estimates how satisfied the participants is with different areas of life, as well as how important each area of life is. Minimum scale 0. Maximum scale 48. A higher score means a better outcome.	6, 12, 24 months
Secondary	Quality of life according to EQ-5D-5L	The questionnaire investigates the dimensions mobility, self-care, usual activities, pain and anxiety/depression. Minimum value 1. Maximum value 5. A higher score means a worse outcome. In addition, a general health score is assessed. Minimum value 0. Maximum value 100. A higher score means a better outcome. All dimension will be analysed separately, but EQ-5D-5L will also be combined to one score.	6, 12, 24 months
Secondary	Eating habits	FFQ 2020 questionnaire	6, 12, 24 months
Secondary	Estimation of health	SF-36 questionnaire	6, 12, 24 months
Secondary	Daily steps	Measured with activity tracker	6, 12, 24 months
Secondary	Study experience	Qualitative questions with written answers about study experience	24 months
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	Collected from patient journals after study completion	Yearly up to 20 years
Secondary	Usage of diabetes medication follow-up	Collected from patient journals after study completion	Yearly up to 20 years
Secondary	Usage of hypertension medication 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