Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Self-regulation health education; Behavioral: Usual diabetes health education

• Registration Number: NCT05367622
• Lead Sponsor: Chang Gung University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-10
• Study Start: 2022-12-01
• Primary Completion: 2023-01-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous glucose monitoring group	Self-regulation health education	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	Usual diabetes health education	Usual diabetes health education will be given for 1 hr.

Primary Outcome Measures

Name	Time	Method
Diabetes self-efficacy scale	3 months after intervention	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.
24-hr blood glucose	7 days during intervention	Blood glucose indicators
Medication compliance	3 months after intervention	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.
HbA1C	3 months after intervention	Blood glucose indicators
Fasting blood glucose	3 months after intervention	Blood glucose indicators
Diabetes health promoting behavior scale	3 months after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Body composition analysis	3 months after intervention	percentage of fat, bone, and muscle in your body
Diabetes health literacy assessment scale	3 months after intervention	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.

Trial Locations

Locations (1)

CHENG GUNG MEMORIAL HOSPITAL, Linkou; 🇨🇳 Taoyuan City, Guishan District, Taiwan