Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The eHealth Diabetes Remission Trial - Pilot Study (eDIT-pilot)

29. januar 2022 opdateret af: Julia Otten

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Umeå, Sverige, 90187
        • Department of Public Health and Clinical Medicine, Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Julia Otten, MD, PhD, Umeå University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. marts 2021

Primær færdiggørelse (Faktiske)

29. januar 2022

Studieafslutning (Faktiske)

29. januar 2022

Datoer for studieregistrering

Først indsendt

13. marts 2021

Først indsendt, der opfyldte QC-kriterier

17. marts 2021

Først opslået (Faktiske)

18. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Abonner