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

29. januar 2022 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Julia Otten, MD, PhD, Umeå University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. mars 2021

Primær fullføring (Faktiske)

29. januar 2022

Studiet fullført (Faktiske)

29. januar 2022

Datoer for studieregistrering

Først innsendt

13. mars 2021

Først innsendt som oppfylte QC-kriteriene

17. mars 2021

Først lagt ut (Faktiske)

18. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. januar 2022

Sist bekreftet

1. januar 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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