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O estudo clínico NCT04809311 para Diabetes mellitus, tipo 2 está concluído. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Novo NordiskRemote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments 156 Remoto Virtual
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT04809311 foi um estudo observacional para Diabetes mellitus, tipo 2. Seu status atual é: concluído. O estudo começou em 30 de abril de 2024 e incluiu 156 participantes. Coordenado por Novo Nordisk e foi concluído em 7 de janeiro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 21 de março de 2025.
Resumo
Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, e...Mostrar mais
Título oficial
Fully Decentralised Clinical Study Exploring Remote Collection of Glycaemic and Behaviometric Data Among Participants With Type 2 Diabetes Mellitus on Different Treatment Regimens
Condições médicas
Diabetes mellitus, tipo 2Outros IDs do estudo
- NN1535-7774
- U1111-1254-5030 (Outro identificador) (World Health Organization (WHO))
Número NCT
Data de início (real)
2024-04-30
Última atualização postada
2025-03-21
Data de conclusão (estimada)
2025-01-07
Inscrição (estimada)
156
Tipo de estudo
Observacional
Status
Concluído
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Other oral antidiabetic drugs (OADs) ± metformin Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Oral antidiabetetic drugs During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
Basal insulin ± OADs Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Basal insulin During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
Glucagon-like peptide-1 (GLP-1) ± Basal insulin (loose and fixed combination) ± OADs Patients will continue their antidiabetic treatment as per usual clinical practice at the discretion of their own treating physician | Basal insulin During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration Glucagon-like peptide-1 (GLP-1) During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
Approximately 12-week study duration |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Participant invited to consent and consented via e-signature (Yes/No) | Measured as count of participants. | During Screening (Week -2 to week 0 ) |
Participant with at least 70% unblinded CGM (continuous glucose monitoring) data (Yes/No) | Measured as Count of participants. | From time of first unblinded CGM measurement until 10 weeks after the time of first unblinded CGM measurement |
Participant completion of questionnaires and per protocol planned remote visits (RVs) | % of questionnaires and RVs completed. | From week 0 until end of study (week 12) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Time in range (TIR) (3.9-10 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time above range (TAR) (above 10 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time below range (TBR) L1 (3.0-3.9 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Time below range (TBR) L2 (below 3.0 mmol/L) | % of time. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Mean glucose | nmol/L. | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) |
Coefficient of variation (CV) of glucose measurements | From time of first unblinded CGM measurement (week 2) until time of last unblinded CGM measurement (week 12) | |
Participant with at least 70% heart rate (pulse) data (Yes/No) | Count of participants. | From time of first heart rate measurement (week 0) until 12 weeks after the time of first heart rate measurement |
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
Willingness to consent via the e-consent process before any study-related activities takes place (study-related activities are any procedure related to recording of data according to the protocol)
Male or female, age above or equal to 18 years at the time of signing informed consent
Diagnosed T2DM for more than 3 months prior to signing the informed consent
On one of the following treatments for T2DM:
- Metformin ± other OADs
- Basal insulin ± OADs
- GLP-1 ± Basal insulin (loose and fixed combination) ± OADs
Willingness to, and capable of applying and using the study devices
Willingness to follow study procedures
Fluent in Danish both oral, reading and in writing
In possession of a compatible smartphone throughout the study, meaning that the smartphone fulfils the criteria to the operating system for using the devices needed for the study
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Participation in any other study investigating diabetes.
- Patients who do not have a blood glucose meter at home
Novo Nordisk131 estudos clínicos ativos para explorarSem dados de contato.
1 Locais do estudo em 1 países
Digital/virtual site, Copenhegan, Denmark