Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Blood Glucose Monitoring on Behavior Change in Patients With Poorly Controlled Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Self-regulation health education
* Behavioral: Usual diabetes health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with diabetes by a doctor, and the patient is over 20 years old Hemoglobin A1C (HbA1C)> 8 % or more Possessed self-monitoring equipment for blood glucose ability to use a mobile phone before participation, the subject fully understand the purpose and process of the research and obtain their consent. Exclusion Criteria: Diabetes health literacy lower than 9 points Those who have difficulty in visual, hearing and speech. Use of diuretics and steroids

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous glucose monitoring group<br>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<br>* Insert the continuous blood glucose monitor 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 Use Telecommunications on the modifications of health promotion behaviors for 7 days<br>|
| Placebo Comparator: Self-monitoring of blood glucose group<br>Usual diabetes health education will be given for 1 hr. | Behavioral: Usual diabetes health education<br>* Practice self-monitoring of blood glucose Give usual diabetes health education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Continuous blood glucose monitoring, Self-regulation, Blood glucose, Diabetes health promotion behavior, Diabetes self-efficacy, Medication compliance