- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04805996
The eHealth Diabetes Remission Trial - Pilot Study (eDIT-pilot)
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Umeå, Sverige, 90187
- Department of Public Health and Clinical Medicine, Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
This study has only one arm and no comparator.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight loss
Tidsramme: 6 months
|
Weight loss goal of 15 kg, measured at the research facilities
|
6 months
|
|
HbA1c
Tidsramme: 6 months
|
The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication.
(Secondary goal < 42 mmol/mol.)
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Semi-structured interviews
Tidsramme: 6 months
|
6 months
|
|
|
Fasting blood glucose
Tidsramme: Daily measurements up to 6 months
|
Partial diabetes remission (< 7.0 mol/l), complete diabetes remission (<6.1 mol/l)
|
Daily measurements up to 6 months
|
|
Fasting blood glucose
Tidsramme: 6 months
|
Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.
|
6 months
|
|
P-glucose 120 minutes after the oral glucose tolerance test
Tidsramme: 6 months
|
Measured at the research facilities
|
6 months
|
|
Insulin secretion
Tidsramme: At baseline, 3 months and 6 months
|
Measured with oral glucose tolerance test
|
At baseline, 3 months and 6 months
|
|
Insulin sensitivity
Tidsramme: At baseline, 3 months and 6 months
|
Measured with oral glucose tolerance test
|
At baseline, 3 months and 6 months
|
|
Metabolic flexibility
Tidsramme: At baseline, 3 months and 6 months
|
Measured with indirect calorimetry during oral glucose tolerance test
|
At baseline, 3 months and 6 months
|
|
Blood pressure (systolic/diastolic)
Tidsramme: At baseline, 3 months and 6 months
|
Measured at the research facilities
|
At baseline, 3 months and 6 months
|
|
Blood pressure (systolic/diastolic)
Tidsramme: Daily measurements up to 6 months
|
Measured at home
|
Daily measurements up to 6 months
|
|
Blood pressure medication
Tidsramme: 6 months
|
Change of blood pressure medication during the study
|
6 months
|
|
Body weight
Tidsramme: Daily measurements up to 6 months
|
Measured at home
|
Daily measurements up to 6 months
|
|
HbA1c
Tidsramme: Monthly measurement up to 6 months
|
Measured at home
|
Monthly measurement up to 6 months
|
|
Diabetes medication
Tidsramme: 6 months
|
Change of diabetes medication during study duration
|
6 months
|
|
Plasma lipid profile
Tidsramme: At baseline, 3 months and 6 months
|
Measured at the research facilities
|
At baseline, 3 months and 6 months
|
|
Waist circumference
Tidsramme: Baseline, 3 months and 6 months
|
Measured in cm at the research facilities
|
Baseline, 3 months and 6 months
|
|
EQ-5D-5L
Tidsramme: At baseline, 3 months and 6 months
|
Questionnaire
|
At baseline, 3 months and 6 months
|
|
Food frequency form
Tidsramme: At baseline and 6 months
|
Questionnaire
|
At baseline and 6 months
|
|
Daily steps
Tidsramme: During the second three months of the study
|
Measured with activity tracker
|
During the second three months of the study
|
|
HbA1c follow up
Tidsramme: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Body weight follow up
Tidsramme: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Blood pressure follow up (systolic/diastolic)
Tidsramme: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Antidiabetic medication usage follow up
Tidsramme: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Blood pressure medication usage follow up
Tidsramme: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Diabetes complications follow up
Tidsramme: Yearly up to 20 years
|
Collected from patient journals and registries after study completion
|
Yearly up to 20 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Julia Otten, MD, PhD, Umeå University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Dnr 2021-00318
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .