- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Umeå, Suecia, 90187
- Department of Public Health and Clinical Medicine, Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Weight loss
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Semi-structured interviews
Periodo de tiempo: 6 months
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6 months
|
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Fasting blood glucose
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months
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Measured at the research facilities
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6 months
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Insulin secretion
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Julia Otten, MD, PhD, Umea University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Dnr 2021-00318
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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