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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Change of HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: feedback counseling (Behavioral)
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).
干预措施: feedback counseling (Behavioral)
结局指标
主要结局
Change of HbA1c
时间窗: Baseline and 3 months after CGM counseling
Change of HbA1c in 3 months after CGM counseling.
Change of score for self efficacy
时间窗: 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.
次要结局
- Change in exercise amount, time spent in moderate activity(Baseline and 3 months after CGM counseling)
- Change of score for diabetes associated stress(Baseline and 3 months after CGM counseling)
- Change of score for depression(Baseline and 3 months after CGM counseling)
- Change in diet composition(Baseline and 3 months after CGM counseling)
- Change in exercise amount, time spent in light activity(Baseline and 3 months after CGM counseling)
- Change in exercise amount, time spent in intense activity(Baseline and 3 months after CGM counseling)
- Change in exercise amount (time spent in sedentary behavior)(Baseline and 3 months after CGM counseling)