Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous glucose monitoring group | Experimental | Self-regulation model of health education will be given for 1-1.5 hrs and telecommunication 10 to 15 minutes for 7 days |
|
| Self-monitoring of blood glucose group | Placebo Comparator | Usual diabetes health education will be given for 1 hr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-regulation health education | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose | Blood glucose indicators | Pre-test(baseline) |
| Fasting blood glucose | Blood glucose indicators | 7 days during intervention |
| Fasting blood glucose | Blood glucose indicators | 3 months after intervention |
| 24-hr blood glucose | Blood glucose indicators | 7 days during intervention |
| HbA1C | Blood glucose indicators | Pre-test(baseline) |
| HbA1C | Blood glucose indicators | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition analysis | percentage of fat, bone, and muscle in your body | Pre-test(baseline) |
| Body composition analysis | percentage of fat, bone, and muscle in your body |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHENG GUNG MEMORIAL HOSPITAL, Linkou | Taoyuan City | Guishan District | 333 | Taiwan |
there is no plan to make individual participant data (IPD) available to other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D000068356 | Self-Control |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
The research investigators and care provider do not participate in the research processes of recruitment, allocation, and intervention. Simple randomization will be assigned subjects into two groups with prepared envelopes in advance. Both groups had intervention, so the participants did not know whether they belonged to the experimental group or the control group. Outcomes assessor and care provider are different persons. Data will be collected according the list of participants.
|
| Usual diabetes health education | Behavioral |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 months after intervention |
| 8 days after intervention |
| Body composition analysis | percentage of fat, bone, and muscle in your body | 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. | 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. | 3 months after intervention |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |