Type 2 Diabetes
Conditions
Keywords
Diabetes, Continuous blood glucose monitoring, Self-regulation, Blood glucose, Diabetes health promotion behavior, Diabetes self-efficacy, Medication compliance
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSelf-regulation 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
BEHAVIORALUsual diabetes health education
1. Practice self-monitoring of blood glucose 2. Give usual diabetes health education
Sponsors
Chang Gung University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with diabetes by a doctor, and the patient is over 20 years old 2. Hemoglobin A1C (HbA1C)\> 8 % or more 3. Possessed self-monitoring equipment for blood glucose 4. ability to use a mobile phone 5. before participation, the subject fully understand the purpose and process of the research and obtain their consent.
Exclusion criteria
1. Diabetes health literacy lower than 9 points 2. Those who have difficulty in visual, hearing and speech. 3. Use of diuretics and steroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication compliance | Pre-test(baseline) | 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. |
| Diabetes self-efficacy scale | Pre-test(baseline) | 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. |
| Diabetes health promoting behavior scale | Pre-test(baseline) | 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. |
| Fasting blood glucose | Pre-test(baseline) | Blood glucose indicators |
| 24-hr blood glucose | 7 days during intervention | Blood glucose indicators |
| HbA1C | Pre-test(baseline) | Blood glucose indicators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes health literacy assessment scale | Pre-test(baseline) | 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. |
| Body composition analysis | Pre-test(baseline) | percentage of fat, bone, and muscle in your body |
Countries
Taiwan
Outcome results
None listed