Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

NCT05367622 | Unknown

• 1 other identifier: ZORPF3M0011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Continuous blood glucose monitoring; Self-regulation; Blood glucose; Diabetes health promotion behavior; Diabetes self-efficacy; Medication compliance

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (5)

• Body composition analysis

  Pre-test(baseline)

• Body composition analysis

  8 days after intervention

• Body composition analysis

  3 months after intervention

• Diabetes health literacy assessment scale

  Pre-test(baseline)

• Diabetes health literacy assessment scale

  3 months after intervention

Study Arms (2)

Continuous glucose monitoring group

EXPERIMENTAL

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

Self-monitoring of blood glucose group

PLACEBO COMPARATOR

Usual diabetes health education will be given for 1 hr.

Behavioral: Usual diabetes health education

Interventions

Self-regulation health education BEHAVIORAL

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

Continuous glucose monitoring group

Usual diabetes health education BEHAVIORAL

1. Practice self-monitoring of blood glucose 2. Give usual diabetes health education

Self-monitoring of blood glucose group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diabetes health literacy lower than 9 points
• Those who have difficulty in visual, hearing and speech.
• Use of diuretics and steroids

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead

Study Sites (1)

CHENG GUNG MEMORIAL HOSPITAL, Linkou

Taoyuan, Guishan District, 333, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Self-Control; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 10, 2022
• Study Start: December 1, 2022
• Primary Completion: January 13, 2023
• Study Completion: June 30, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)