An interventional study of Self-regulation health education and Usual diabetes health education in Type 2 Diabetes, sponsored by Chang Gung University of Science and Technology. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Chang Gung University of Science and Technology · Not applicable, Interventional, and Supportive care
This purpose of this study is to investigate the effect of the self-regulation mode of continuous blood glucose monitoring on blood glucose indicators, self-efficacy, health-promoting behaviors, and medication compliance in patients with Type 2 diabetes. A prospective, randomized, double-blind experimental study is designed with 60 diabetic patients randomly assigned to the experimental group receiving continuous blood glucose monitoring and self-regulation mode of health education and the control group receiving self-monitoring of blood glucose and routine health education. Data will be collected three times, including blood glucose indicators and scales of self-efficacy, health promotion behaviors, and medication compliance.
This purpose of this study is to investigate the effect of the self-regulation mode of continuous blood glucose monitoring on blood glucose indicators, self-efficacy, health-promoting behaviors, and medication compliance in patients with Type 2 diabetes. This study is a prospective, randomized, double-blind experimental study. A total of 60 diabetic patients who are willing to participate in the outpatient clinic of the hospital will be recruited. They are randomly assigned to the experimental group and the control group with 30 patients each. The experimental group will adopt continuous blood glucose monitoring for 7 days and self-regulation mode of health education, while the control group is self-monitoring of blood glucose and routine health education. Data will be collected three times: pre-test, eighth day after intervention, and three-month after intervention. The data included blood glucose indicators and scales of self-efficacy, health promotion behaviors, and medication compliance.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Self-regulation model of health education will be given for 1-1.5 hrs and telecommunication 10 to 15 minutes for 7 days
Behavioral: Self-regulation health education
Usual diabetes health education will be given for 1 hr.
Behavioral: Usual diabetes health education
1. Insert the continuous blood glucose monitor 2. Give self-regulation model of health education to assist patients in making a judgmental decision on how to modify health promotion behaviors to reach a good glucose control 3. Use Telecommunications on the modifications of health promotion behaviors for 7 days
1. Practice self-monitoring of blood glucose 2. Give usual diabetes health education
Fasting blood glucose
Blood glucose indicators
Time frame: Pre-test(baseline)
Fasting blood glucose
Blood glucose indicators
Time frame: 7 days during intervention
Fasting blood glucose
Blood glucose indicators
Time frame: 3 months after intervention
24-hr blood glucose
Blood glucose indicators
Time frame: 7 days during intervention
HbA1C
Blood glucose indicators
Time frame: Pre-test(baseline)
HbA1C
Blood glucose indicators
Time frame: 3 months after intervention
Diabetes self-efficacy scale
Use the options of "extremely confident", "moderately confident", "slightly confident" ", "Not very confident", and "Not confident at all" to assess self-efficacy in the performance of diabetes health promotion behaviors; minimum and maximum values are from 17-85 scores, Higher scores mean a better self-efficacy.
Time frame: Pre-test(baseline)
Diabetes self-efficacy scale
Use the options of "extremely confident", "moderately confident", "slightly confident" ", "Not very confident", and "Not confident at all" to assess self-efficacy in the performance of diabetes health promotion behaviors; minimum and maximum values are from 17-85 scores, Higher scores mean a better self-efficacy.
Time frame: 8 days after intervention
Diabetes self-efficacy scale
Use the options of "extremely confident", "moderately confident", "slightly confident" ", "Not very confident", and "Not confident at all" to assess self-efficacy in the performance of diabetes health promotion behaviors; minimum and maximum values are from 17-85 scores, Higher scores mean a better self-efficacy.
Time frame: 3 months after intervention
Diabetes health promoting behavior scale
Use the options of "always", "often", "sometimes", "occasionally", and "never", to assess the performance of diabetes health promotion behaviors; minimum and maximum values are from 17-85 scores, Higher scores mean a better health promoting behaviors.
Time frame: Pre-test(baseline)
Diabetes health promoting behavior scale
Use the options of "always", "often", "sometimes", "occasionally", and "never", to assess the performance of diabetes health promotion behaviors; minimum and maximum values are from 17-85 scores, Higher scores mean a better health promoting behaviors.
Time frame: 8 days after intervention
Diabetes health promoting behavior scale
Use the options of "always", "often", "sometimes", "occasionally", and "never", to assess the performance of diabetes health promotion behaviors; minimum and maximum values are from 17-85 scores, Higher scores mean a better health promoting behaviors.
Time frame: 3 months after intervention
Medication compliance
Use the 5-point Likert scale to assess compliance behaviors; minimum and maximum values are from 0-8 scores, Higher scores mean a wose medication compliance.
Time frame: Pre-test(baseline)
Medication compliance
Use the 5-point Likert scale to assess compliance behaviors; minimum and maximum values are from 0-8 scores, Higher scores mean a wose medication compliance.
Time frame: 8 days after intervention
Medication compliance
Use the 5-point Likert scale to assess compliance behaviors; minimum and maximum values are from 0-8 scores, Higher scores mean a wose medication compliance.
Time frame: 3 months after intervention
Body composition analysis
percentage of fat, bone, and muscle in your body
Time frame: Pre-test(baseline)
Body composition analysis
percentage of fat, bone, and muscle in your body
Time frame: 8 days after intervention
Body composition analysis
percentage of fat, bone, and muscle in your body
Time frame: 3 months after intervention
Diabetes health literacy assessment scale
A person's capacity to obtain, process, and understand basic health information needed to make appropriate health decisions; minimum and maximum values are from 0-12 scores, Higher scores mean a better wose health literacy.
Time frame: Pre-test(baseline)
Diabetes health literacy assessment scale
A person's capacity to obtain, process, and understand basic health information needed to make appropriate health decisions; minimum and maximum values are from 0-12 scores, Higher scores mean a better wose health literacy.
Time frame: 3 months after intervention
Plan to share: No — there is no plan to make individual participant data (IPD) available to other researchers.
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Chang Gung University of Science and Technology