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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Umeå, Suécia, 90187
- Department of Public Health and Clinical Medicine, Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Weight loss
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Semi-structured interviews
Prazo: 6 months
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6 months
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Fasting blood glucose
Prazo: 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
Prazo: 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
Prazo: 6 months
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Measured at the research facilities
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6 months
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Insulin secretion
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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, Umeå University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Dnr 2021-00318
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