- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03792399
Continuous Glucose Monitoring With Immediate or Delayed Counseling Feedback
Impact of Innovative Technology on Geriatric Diabetic Patients: Evaluation of Quality of Life, Self Efficacy and Glycemic Control Among Patients With Experience of Continuous Glucose Monitoring
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
After scheduled routine professional continuous glucose monitoring (CGM) exam, participants in both the intervention and control group receive ordinary education and regimen adjustment as indicated based on CGM results. For participants in the intervention group, they will also receive CGM counseling immediately on the day of CGM sensor removal. For participants in the control group, they will receive CGM counseling on the day of routine 3 months outpatient visit.
Qualitative data are collected through in-depth interview: User expectation, acceptability and satisfaction of CGM are also explored during in-depth interview with a semi-structured questionnaire.
Quantitative data were collected through validated questionnaires, including evaluation of depression by a short form of the Center for Epidemiologic Studies Depression Scale Revised (CES-D-R), emotional stress by Problem Areas in Diabetes Scale (PAID), self efficacy by Stanford Self-Efficacy for Diabetes (SES), at pretest and 3 months after CGM counseling.
Anthropometric Measurements. Body height, body weight, body mass index, and blood pressure were recorded at pre-test and post-test interview.
Blood Tests. Routine biochemistry, fasting plasma glucose, hemoglobin A1c (HbA1c) are collected within 2 weeks of pretest and posttest day.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 45 years old or more at recent outpatient visits;
- Type 2 diabetic patients followed up at National Cheng Kung University Hospital;
- Patients planned to receive CGM suggested by primary care physician due to inadequate controlled blood glucose.
Exclusion Criteria:
- Patients with diagnosis of generalized inflammation, advanced malignancy, end-stage renal disease on regular dialysis, status post renal transplantation, end-stage liver, heart or pulmonary disease;
- Patients who are taking systemic glucocorticoids;
- Any acute or chronic inflammatory disease as determined by a leukocyte count over 10,000/mm3 or clinical signs of infection;
- Patients who could not complete the questionnaires or who could not follow order due to cognitive impairment or in bed-ridden status;
- Patients diagnosed as thalassemia, glucose-6-phosphate dehydrogenase deficiency, and any other hemoglobinopathies that may influence the accuracy of hemoglobulin A1c measurement were also excluded. Patients who received blood transfusion in recent 3 months were also excluded.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Immediate feedback counseling
Professional CGM calibrate blood glucose via a glucsoe-oxidase-impregnated membrane during a 5 day period.
The patient wearing professional CGM is randomized to immediate feedback after data downloaded into computer.
|
Professoinal CGM in combination with diet and exercise record is used as teaching material to help patient realize their blood glucose pattern and to modify their behavior after counseling feedback.
|
Outro: Delayed feedback counseling
Professional CGM calibrate blood glucose via a glucsoe-oxidase-impregnated membrane during a 5 day period.
The patient wearing professional CGM is randomized to delayed feedback (standard care, i.e., CGM graphs interpretation at scheduled 3 months outpatient visit).
|
Professoinal CGM in combination with diet and exercise record is used as teaching material to help patient realize their blood glucose pattern and to modify their behavior after counseling feedback.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change of HbA1c
Prazo: Baseline and 3 months after CGM counseling
|
Change of HbA1c in 3 months after CGM counseling.
|
Baseline and 3 months after CGM counseling
|
Change of score for self efficacy
Prazo: Baseline and 3 months after CGM counseling
|
Change of Stanford Self-Efficacy for Diabetes Scale (SES) in 3 months after CGM counseling.
The score for each item ranged from 1-10.
The score of the scale is the mean of the eight items.
Higher number indicated higher self-efficacy.
|
Baseline and 3 months after CGM counseling
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change of score for diabetes associated stress
Prazo: Baseline and 3 months after CGM counseling
|
Change of score for Problem Areas in Diabetes Scale (PAID) in 3 months after CGM counseling.
PAID is a 20-item self-reported questionnaire with scale 0-4 for each question, generating a total score of 0-100.
A score of ≥ 40 is defined as emotional burnout.
|
Baseline and 3 months after CGM counseling
|
Change of score for depression
Prazo: Baseline and 3 months after CGM counseling
|
Change of score for Center for Epidemiologic Studies Depression Scale Revised (CESD-R) in 3 months after CGM counseling.
With 10-ietm CESD-R scale scoring 10 or more defined as having depression (range 0 to 30).
|
Baseline and 3 months after CGM counseling
|
Change in diet composition
Prazo: Baseline and 3 months after CGM counseling
|
Change of carbohydrate amounts, fruits amount in 3 months after CGM counseling.
|
Baseline and 3 months after CGM counseling
|
Change in exercise amount, time spent in light activity
Prazo: Baseline and 3 months after CGM counseling
|
Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband).
Time spent in light activity per day in 3 months after CGM counseling feedback is compared with baseline.
|
Baseline and 3 months after CGM counseling
|
Change in exercise amount, time spent in moderate activity
Prazo: Baseline and 3 months after CGM counseling
|
Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband).
Time spent in moderate activity per day in 3 months after CGM counseling feedback is compared with baseline.
|
Baseline and 3 months after CGM counseling
|
Change in exercise amount, time spent in intense activity
Prazo: Baseline and 3 months after CGM counseling
|
Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband).
Time spent in intense activity per day in 3 months after CGM counseling feedback is compared with baseline.
|
Baseline and 3 months after CGM counseling
|
Change in exercise amount (time spent in sedentary behavior)
Prazo: Baseline and 3 months after CGM counseling
|
Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband).
Time spent in sedentary behavior in 3 months after CGM counseling feedback is compared with baseline.
|
Baseline and 3 months after CGM counseling
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Ching-Ju Chiu, Ph.D., Institute of Gerontology, NCKU
- Investigador principal: Ye-Fong Du, M.D., NCKUH
Publicações e links úteis
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
Outros números de identificação do estudo
- NCKUH-10508011
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em feedback counseling
-
The University of Tennessee, KnoxvilleColorado State UniversityAtivo, não recrutandoTranstorno por Uso de Cannabis, Leve | Transtorno por Uso de Cannabis, Moderado | Transtorno do Uso de Cannabis, GraveEstados Unidos
-
University of MichiganInscrevendo-se por conviteDepressão | Ansiedade | Distúrbios de sono | VícioEstados Unidos
-
University of North Carolina, Chapel HillNational Institute on Deafness and Other Communication Disorders (NIDCD)ConcluídoAfasia | Acidente vascular cerebral | Apraxia de falaEstados Unidos
-
University Hospital, CaenDesconhecidoParagem cardíacaFrança
-
Pusan National University HospitalConcluídoAtividade física | Síndrome metabólica | Dispositivo vestívelRepublica da Coréia
-
Aveiro UniversityConcluído
-
Northwestern UniversityConcluídoTranstorno do Espectro Autista | AutismoEstados Unidos
-
Massachusetts General HospitalRobert Wood Johnson FoundationConcluídoRotulagem de alimentosEstados Unidos
-
KEMRI-Wellcome Trust Collaborative Research ProgramConcluído
-
Semmelweis UniversityRecrutamentoRessuscitação cardiopulmonar | Suporte de vida básico | Educação pré-médica | Habilidades de EstudoHungria