Type 2 DiabetesNCT05367622
Blood Glucose Monitoring on Behavior Change in Type 2 Diabetes
A study testing Self-regulation health education and Usual diabetes health education in people with Type 2 Diabetes, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Self-regulation health education and Usual diabetes health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetes health literacy lower than 9 points
- Those who have difficulty in visual, hearing and speech.
- Use of diuretics and steroids
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
CHENG GUNG MEMORIAL HOSPITAL, Linkou
Taoyuan City, Guishan District, 333
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Self-regulation health education, Usual diabetes health education
- Keywords
- Diabetes, Continuous blood glucose monitoring, Self-regulation, Blood glucose, Diabetes health promotion behavior, Diabetes self-efficacy, Medication compliance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Self-Control, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-regulation health educationBehavioural
- 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 educationBehavioural
- Practice self-monitoring of blood glucose
- Give usual diabetes health education
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Self-regulation health education |
| Self-monitoring of blood glucose group | Placebo comparator | Usual diabetes health education will be given for 1 hr. Receives: Behavioral: Usual diabetes health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Blood glucose indicators
Measured: Pre-test(baseline)
Fasting blood glucose
Blood glucose indicators
Measured: 7 days during intervention
Fasting blood glucose
Blood glucose indicators
Measured: 3 months after intervention
24-hr blood glucose
Blood glucose indicators
Measured: 7 days during intervention
HbA1C
Blood glucose indicators
Measured: Pre-test(baseline)
HbA1C
Blood glucose indicators
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after intervention
Secondary outcomes (5)
Body composition analysis
percentage of fat, bone, and muscle in your body
Measured: Pre-test(baseline)
Body composition analysis
percentage of fat, bone, and muscle in your body
Measured: 8 days after intervention
Body composition analysis
percentage of fat, bone, and muscle in your body
Measured: 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.
Measured: 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.
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Dec 2022
- Primary completion13 Jan 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yun Chang, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367622
- Sponsor's protocol ID
- ZORPF3M0011
- Status last verified
- Aug 2023
- First submitted
- 27 Apr 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Glucose Monitoring on Behavior Change in Patients With Poorly Controlled Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05367622
- Acronym / sponsor ID
- ZORPF3M0011
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Continuous blood glucose monitoring, Self-regulation, Blood glucose, Diabetes health promotion behavior, Diabetes self-efficacy, Medication compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring group | Experimental | Behavioral: Self-regulation health educationSelf-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 | Placebo comparator | Behavioral: Usual diabetes health educationUsual diabetes health education will be given for 1 hr. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Diabetes health literacy lower than 9 points
- Those who have difficulty in visual, hearing and speech.
- Use of diuretics and steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-regulation health education1. 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 | Behavioural | Continuous glucose monitoring group |
| Usual diabetes health education1. Practice self-monitoring of blood glucose 2. Give usual diabetes health education | Behavioural | Self-monitoring of blood glucose group |
Primary outcome
Fasting blood glucose
Time frame: Pre-test(baseline)
Blood glucose indicators
Fasting blood glucose
Time frame: 7 days during intervention
Blood glucose indicators
Fasting blood glucose
Time frame: 3 months after intervention
Blood glucose indicators
24-hr blood glucose
Time frame: 7 days during intervention
Blood glucose indicators
HbA1C
Time frame: Pre-test(baseline)
Blood glucose indicators
HbA1C
Time frame: 3 months after intervention
Blood glucose indicators
Diabetes self-efficacy scale
Time frame: Pre-test(baseline)
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
Time frame: 8 days 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.
Diabetes self-efficacy scale
Time frame: 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.
Diabetes health promoting behavior scale
Time frame: Pre-test(baseline)
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
Time frame: 8 days 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.
Diabetes health promoting behavior scale
Time frame: 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.
Medication compliance
Time frame: Pre-test(baseline)
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
Time frame: 8 days 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.
Medication compliance
Time frame: 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.
5 secondary outcomes
Body composition analysis
Time frame: Pre-test(baseline)
Body composition analysis
Time frame: 8 days after intervention
Body composition analysis
Time frame: 3 months after intervention
Diabetes health literacy assessment scale
Time frame: Pre-test(baseline)
Diabetes health literacy assessment scale
Time frame: 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No. there is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-regulation health education and Usual diabetes health education in people with Type 2 Diabetes, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: Pre-test(baseline)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.