Continuous Glucose Monitoring With Immediate or Delayed Counseling Feedback
1 de enero de 2019 actualizado por: National Cheng-Kung University Hospital
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
This study is designed to explore the effect of feedback counseling using professional continuous glucose monitoring on glycemic control, self-efficacy, and self-management behaviors among middle aged and older adults with poor controlled type 2 diabetes mellitus.
This study also explores the difference on timing of feedback after continuous glucose monitoring exam.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
20
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
45 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
Otro: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of HbA1c
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of score for diabetes associated stress
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Ching-Ju Chiu, Ph.D., Institute of Gerontology, NCKU
- Investigador principal: Ye-Fong Du, M.D., NCKUH
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de marzo de 2016
Finalización primaria (Actual)
12 de octubre de 2017
Finalización del estudio (Actual)
12 de octubre de 2017
Fechas de registro del estudio
Enviado por primera vez
8 de noviembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
1 de enero de 2019
Publicado por primera vez (Actual)
3 de enero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
1 de enero de 2019
Última verificación
1 de noviembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NCKUH-10508011
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The study protocol will be shared after study publication.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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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