- ICH GCP
- Registr klinických studií v USA
- Klinická 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Umeå, Švédsko, 90187
- Department of Public Health and Clinical Medicine, Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
This study has only one arm and no comparator.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Weight loss
Časové okno: 6 months
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Weight loss goal of 15 kg, measured at the research facilities
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6 months
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HbA1c
Časové okno: 6 months
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The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication.
(Secondary goal < 42 mmol/mol.)
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6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Semi-structured interviews
Časové okno: 6 months
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6 months
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Fasting blood glucose
Časové okno: Daily measurements up to 6 months
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Partial diabetes remission (< 7.0 mol/l), complete diabetes remission (<6.1 mol/l)
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Daily measurements up to 6 months
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Fasting blood glucose
Časové okno: 6 months
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Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.
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6 months
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P-glucose 120 minutes after the oral glucose tolerance test
Časové okno: 6 months
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Measured at the research facilities
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6 months
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Insulin secretion
Časové okno: At baseline, 3 months and 6 months
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Measured with oral glucose tolerance test
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At baseline, 3 months and 6 months
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Insulin sensitivity
Časové okno: At baseline, 3 months and 6 months
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Measured with oral glucose tolerance test
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At baseline, 3 months and 6 months
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Metabolic flexibility
Časové okno: At baseline, 3 months and 6 months
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Measured with indirect calorimetry during oral glucose tolerance test
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At baseline, 3 months and 6 months
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Blood pressure (systolic/diastolic)
Časové okno: At baseline, 3 months and 6 months
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Measured at the research facilities
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At baseline, 3 months and 6 months
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Blood pressure (systolic/diastolic)
Časové okno: Daily measurements up to 6 months
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Measured at home
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Daily measurements up to 6 months
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Blood pressure medication
Časové okno: 6 months
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Change of blood pressure medication during the study
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6 months
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Body weight
Časové okno: Daily measurements up to 6 months
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Measured at home
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Daily measurements up to 6 months
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HbA1c
Časové okno: Monthly measurement up to 6 months
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Measured at home
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Monthly measurement up to 6 months
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Diabetes medication
Časové okno: 6 months
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Change of diabetes medication during study duration
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6 months
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Plasma lipid profile
Časové okno: At baseline, 3 months and 6 months
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Measured at the research facilities
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At baseline, 3 months and 6 months
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Waist circumference
Časové okno: Baseline, 3 months and 6 months
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Measured in cm at the research facilities
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Baseline, 3 months and 6 months
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EQ-5D-5L
Časové okno: At baseline, 3 months and 6 months
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Questionnaire
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At baseline, 3 months and 6 months
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Food frequency form
Časové okno: At baseline and 6 months
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Questionnaire
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At baseline and 6 months
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Daily steps
Časové okno: During the second three months of the study
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Measured with activity tracker
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During the second three months of the study
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HbA1c follow up
Časové okno: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Body weight follow up
Časové okno: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Blood pressure follow up (systolic/diastolic)
Časové okno: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Antidiabetic medication usage follow up
Časové okno: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Blood pressure medication usage follow up
Časové okno: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Diabetes complications follow up
Časové okno: Yearly up to 20 years
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Collected from patient journals and registries after study completion
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Yearly up to 20 years
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Julia Otten, MD, PhD, Umeå University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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