- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Umeå, Schweden, 90187
- Department of Public Health and Clinical Medicine, Medicine
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Weight loss
Zeitfenster: 6 months
|
Weight loss goal of 15 kg, measured at the research facilities
|
6 months
|
|
HbA1c
Zeitfenster: 6 months
|
The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication.
(Secondary goal < 42 mmol/mol.)
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Semi-structured interviews
Zeitfenster: 6 months
|
6 months
|
|
|
Fasting blood glucose
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 months
|
Measured at the research facilities
|
6 months
|
|
Insulin secretion
Zeitfenster: At baseline, 3 months and 6 months
|
Measured with oral glucose tolerance test
|
At baseline, 3 months and 6 months
|
|
Insulin sensitivity
Zeitfenster: At baseline, 3 months and 6 months
|
Measured with oral glucose tolerance test
|
At baseline, 3 months and 6 months
|
|
Metabolic flexibility
Zeitfenster: 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)
Zeitfenster: At baseline, 3 months and 6 months
|
Measured at the research facilities
|
At baseline, 3 months and 6 months
|
|
Blood pressure (systolic/diastolic)
Zeitfenster: Daily measurements up to 6 months
|
Measured at home
|
Daily measurements up to 6 months
|
|
Blood pressure medication
Zeitfenster: 6 months
|
Change of blood pressure medication during the study
|
6 months
|
|
Body weight
Zeitfenster: Daily measurements up to 6 months
|
Measured at home
|
Daily measurements up to 6 months
|
|
HbA1c
Zeitfenster: Monthly measurement up to 6 months
|
Measured at home
|
Monthly measurement up to 6 months
|
|
Diabetes medication
Zeitfenster: 6 months
|
Change of diabetes medication during study duration
|
6 months
|
|
Plasma lipid profile
Zeitfenster: At baseline, 3 months and 6 months
|
Measured at the research facilities
|
At baseline, 3 months and 6 months
|
|
Waist circumference
Zeitfenster: Baseline, 3 months and 6 months
|
Measured in cm at the research facilities
|
Baseline, 3 months and 6 months
|
|
EQ-5D-5L
Zeitfenster: At baseline, 3 months and 6 months
|
Questionnaire
|
At baseline, 3 months and 6 months
|
|
Food frequency form
Zeitfenster: At baseline and 6 months
|
Questionnaire
|
At baseline and 6 months
|
|
Daily steps
Zeitfenster: During the second three months of the study
|
Measured with activity tracker
|
During the second three months of the study
|
|
HbA1c follow up
Zeitfenster: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Body weight follow up
Zeitfenster: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Blood pressure follow up (systolic/diastolic)
Zeitfenster: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Antidiabetic medication usage follow up
Zeitfenster: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Blood pressure medication usage follow up
Zeitfenster: Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Diabetes complications follow up
Zeitfenster: Yearly up to 20 years
|
Collected from patient journals and registries after study completion
|
Yearly up to 20 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Julia Otten, MD, PhD, Umeå University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Dnr 2021-00318
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .