Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Self-regulation health education; Behavioral: Usual diabetes health education

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Guishan District
    • Taoyuan City, Guishan District, Taiwan, 333
      • CHENG GUNG MEMORIAL HOSPITAL, Linkou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous glucose monitoring group; 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; 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
Placebo Comparator: Self-monitoring of blood glucose group; Usual diabetes health education will be given for 1 hr.	Behavioral: Usual diabetes health education; Practice self-monitoring of blood glucose; Give usual diabetes health education

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Blood glucose; Self-regulation; Medication compliance; Continuous blood glucose monitoring; Diabetes health promotion behavior; Diabetes self-efficacy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ZORPF3M0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No