Clinical trial NCT05367622: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Continuous blood glucose monitoring
Self-regulation
Blood glucose
Diabetes health promotion behavior
Diabetes self-efficacy
Medication compliance
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting blood glucose
timeFrame: Pre-test(baseline)
measure: Fasting blood glucose
timeFrame: 7 days during intervention
measure: Fasting blood glucose
timeFrame: 3 months after intervention
measure: 24-hr blood glucose
timeFrame: 7 days during intervention
measure: HbA1C
timeFrame: Pre-test(baseline)
measure: HbA1C
timeFrame: 3 months after intervention
measure: Diabetes self-efficacy scale
timeFrame: Pre-test(baseline)
measure: Diabetes self-efficacy scale
timeFrame: 8 days after intervention
measure: Diabetes self-efficacy scale
timeFrame: 3 months after intervention
measure: Diabetes health promoting behavior scale
timeFrame: Pre-test(baseline)
measure: Diabetes health promoting behavior scale
timeFrame: 8 days after intervention
measure: Diabetes health promoting behavior scale
timeFrame: 3 months after intervention
measure: Medication compliance
timeFrame: Pre-test(baseline)
measure: Medication compliance
timeFrame: 8 days after intervention
measure: Medication compliance
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Body composition analysis
timeFrame: Pre-test(baseline)
measure: Body composition analysis
timeFrame: 8 days after intervention
measure: Body composition analysis
timeFrame: 3 months after intervention
measure: Diabetes health literacy assessment scale
timeFrame: Pre-test(baseline)
measure: Diabetes health literacy assessment scale
timeFrame: 3 months after intervention
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: CHENG GUNG MEMORIAL HOSPITAL, Linkou
state: Guishan District
Study officials:
References: