Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05367622
• Other study ID #: ZORPF3M0011
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Chang Gung University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Self-regulation health education
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
• Usual diabetes health education
Practice self-monitoring of blood glucose Give usual diabetes health education

Locations

Country	Name	City	State
Taiwan	CHENG GUNG MEMORIAL HOSPITAL, Linkou	Taoyuan City	Guishan District

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University of Science and Technology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose	Blood glucose indicators	Pre-test(baseline)
Primary	Fasting blood glucose	Blood glucose indicators	7 days during intervention
Primary	Fasting blood glucose	Blood glucose indicators	3 months after intervention
Primary	24-hr blood glucose	Blood glucose indicators	7 days during intervention
Primary	HbA1C	Blood glucose indicators	Pre-test(baseline)
Primary	HbA1C	Blood glucose indicators	3 months after intervention
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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	Body composition analysis	percentage of fat, bone, and muscle in your body	Pre-test(baseline)
Secondary	Body composition analysis	percentage of fat, bone, and muscle in your body	8 days after intervention
Secondary	Body composition analysis	percentage of fat, bone, and muscle in your body	3 months after intervention
Secondary	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)
Secondary	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