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.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Umeå, Швеция, 90187
- Department of Public Health and Clinical Medicine, Medicine
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Weight loss
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Semi-structured interviews
Временное ограничение: 6 months
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6 months
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Fasting blood glucose
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 6 months
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Measured at the research facilities
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6 months
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Insulin secretion
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Julia Otten, MD, PhD, Umeå University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Dnr 2021-00318
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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