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Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Self-regulation health education
Usual diabetes health education
Sponsored by
Chang Gung University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Diabetes, Continuous blood glucose monitoring, Self-regulation, Blood glucose, Diabetes health promotion behavior, Diabetes self-efficacy, Medication compliance

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHENG GUNG MEMORIAL HOSPITAL, Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Continuous glucose monitoring group

Self-monitoring of blood glucose group

Arm Description

Self-regulation model of health education will be given for 1-1.5 hrs and telecommunication 10 to 15 minutes for 7 days

Usual diabetes health education will be given for 1 hr.

Outcomes

Primary Outcome Measures

Fasting blood glucose
Blood glucose indicators
Fasting blood glucose
Blood glucose indicators
Fasting blood glucose
Blood glucose indicators
24-hr blood glucose
Blood glucose indicators
HbA1C
Blood glucose indicators
HbA1C
Blood glucose indicators
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Body composition analysis
percentage of fat, bone, and muscle in your body
Body composition analysis
percentage of fat, bone, and muscle in your body
Body composition analysis
percentage of fat, bone, and muscle in your body
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.
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.

Full Information

First Posted
April 27, 2022
Last Updated
August 30, 2023
Sponsor
Chang Gung University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05367622
Brief Title
Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes
Official Title
The Effect of Blood Glucose Monitoring on Behavior Change in Patients With Poorly Controlled Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Continuous blood glucose monitoring, Self-regulation, Blood glucose, Diabetes health promotion behavior, Diabetes self-efficacy, Medication compliance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous glucose monitoring group
Arm Type
Experimental
Arm Description
Self-regulation model of health education will be given for 1-1.5 hrs and telecommunication 10 to 15 minutes for 7 days
Arm Title
Self-monitoring of blood glucose group
Arm Type
Placebo Comparator
Arm Description
Usual diabetes health education will be given for 1 hr.
Intervention Type
Behavioral
Intervention Name(s)
Self-regulation health education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Usual diabetes health education
Intervention Description
Practice self-monitoring of blood glucose Give usual diabetes health education
Primary Outcome Measure Information:
Title
Fasting blood glucose
Description
Blood glucose indicators
Time Frame
Pre-test(baseline)
Title
Fasting blood glucose
Description
Blood glucose indicators
Time Frame
7 days during intervention
Title
Fasting blood glucose
Description
Blood glucose indicators
Time Frame
3 months after intervention
Title
24-hr blood glucose
Description
Blood glucose indicators
Time Frame
7 days during intervention
Title
HbA1C
Description
Blood glucose indicators
Time Frame
Pre-test(baseline)
Title
HbA1C
Description
Blood glucose indicators
Time Frame
3 months after intervention
Title
Diabetes self-efficacy scale
Description
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.
Time Frame
Pre-test(baseline)
Title
Diabetes self-efficacy scale
Description
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.
Time Frame
8 days after intervention
Title
Diabetes self-efficacy scale
Description
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.
Time Frame
3 months after intervention
Title
Diabetes health promoting behavior scale
Description
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.
Time Frame
Pre-test(baseline)
Title
Diabetes health promoting behavior scale
Description
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.
Time Frame
8 days after intervention
Title
Diabetes health promoting behavior scale
Description
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.
Time Frame
3 months after intervention
Title
Medication compliance
Description
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.
Time Frame
Pre-test(baseline)
Title
Medication compliance
Description
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.
Time Frame
8 days after intervention
Title
Medication compliance
Description
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.
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
Body composition analysis
Description
percentage of fat, bone, and muscle in your body
Time Frame
Pre-test(baseline)
Title
Body composition analysis
Description
percentage of fat, bone, and muscle in your body
Time Frame
8 days after intervention
Title
Body composition analysis
Description
percentage of fat, bone, and muscle in your body
Time Frame
3 months after intervention
Title
Diabetes health literacy assessment scale
Description
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.
Time Frame
Pre-test(baseline)
Title
Diabetes health literacy assessment scale
Description
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.
Time Frame
3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHENG GUNG MEMORIAL HOSPITAL, Linkou
City
Taoyuan City
State/Province
Guishan District
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to make individual participant data (IPD) available to other researchers.

Learn more about this trial

Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes

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