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Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application

NCT ID: NCT04631159

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-12-30

Brief Summary

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Medical cost in Taiwan for management of diabetes has accounted for the top three. Diabetic patients often have poor self-health managements, there by leading to occurrence of complications. investigators team has previously published that medical staff directly instructed to the elderly with diabetes comorbid with knee osteoarthritis by performing elastic band resistance exercise, participants can improve functional activity after 12 weeks of intervention. However, there was a decrease in glycated hemoglobin (HbA1c), but it did not reach a significant improvement.Investigators also found that how to improve the glycemic control, particularly in during the follow-up periods, and how to increase the amount of physical activity of diabetic patients that may affect the changes in glycated hemoglobin. With the rapid development of up-to-date medical technology, medical applications (apps) has emerging developing to aid self-health management by themselves. Therefore, this project will continue to explore the effectiveness of using simple tracking, monitoring, and immediate feedback on the health management of diabetic patients. Although various apps have been adopted for the monitoring of diabetic patients, few medical professionals regularly use smartphone apps to directly supervise diabetic patients to make immediate remote medical intervention regarding blood glucose, medications, blood pressure, body composition, and even monitor physical activity concurrently.

Detailed Description

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Purpose: To investigate the effectiveness of health management of glycemic control and physical activity in type 2 diabetes mellitus (T2DM) using Smartphone application.

Hypothesis: Clinical medical personnel can monitor data through the mobile app platform and provide personalized lifestyle adjustments based on the information provided by patients, thereby improving patient compliance and effectively self-health management in patients with T2DM. At the same time, through this system, medical personnel can understand the amount of physical activity of the patient during this period, and investigators can promptly encourage patients to reach the set goal of physical activity, which can improve the patient's physical status, so this study can bring a positive effect in both blood glucose and related biomarkers.

Methods: This study will be a randomized controlled trial. Seventy adults (aged 20 to 60 years) diagnosed with T2DM by the physician will recruited and randomly assigned to the mobile app group and the control group. Both groups will receive education by health professionals at Southern Medical Center and participants are required to wear fitness watches to record steps. Mobile app group: patients will need to download and use the Health2Sync app and report blood glucose data weekly, and be monitored and advised by medical personnel. Control group: Patients will be asked to self-manage and there is no intervention during the tracking process.

Conditions

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To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a randomized controlled trial. Seventy adults (aged 20 to 60 years) diagnosed with T2DM by the physician will recruited and randomly assigned to the mobile app group and the control group. Both groups will receive education by health professionals at Southern Medical Center and they are required to wear fitness watches to record steps. Mobile app group: patients will need to download and use the Health2Sync app and report blood glucose data weekly, and be monitored and advised by medical personnel. Control group: Patients will be asked to self-manage and there is no intervention during the tracking process. Each subject will be required to measure body composition, blood pressure, blood biochemical analysis (HbA1C, fasting blood glucose, total cholesterol, low-density cholesterol, high-density cholesterol, triglycerides), and number of steps before and after 12 weeks
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Mobile app group

They are required to wear fitness watches to record steps ,patients will need to download and use the Health2Sync app and report blood glucose data weekly, and be monitored and advised by medical personnel.

Group Type EXPERIMENTAL

Health2Sync app and report blood glucose data weekly

Intervention Type BEHAVIORAL

Patients will need to download and use the Health2Sync app and report blood glucose data weekly

Control group

they are required to wear fitness watches to record steps ,patients will be asked to self-manage and there is no intervention during the tracking process.

Group Type PLACEBO_COMPARATOR

self-manage

Intervention Type OTHER

Patients will be asked to self-manage and there is no intervention during the tracking process

Interventions

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Health2Sync app and report blood glucose data weekly

Patients will need to download and use the Health2Sync app and report blood glucose data weekly

Intervention Type BEHAVIORAL

self-manage

Patients will be asked to self-manage and there is no intervention during the tracking process

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of type2 diabetes
* Age 20 to 60 years old

Exclusion Criteria

* No smartphone, cannot operation of smartphone
* Unable to move
* Use insulin pump
* Pregnant women
* Diagnosis neuropathy
* Diagnosis retinopathy
* Diagnosis diabetic foot
* Diagnosis severe nephropathy ,
* Diagnosis severe liver disease Cognitive impairment
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mei-fang Huang

OTHER

Sponsor Role lead

Responsible Party

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Mei-fang Huang

ChangGungMH Certified Diabetes Educator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chang Nai-Jen

Role: STUDY_DIRECTOR

Kaohsiung Medical University Department of Sports Medicine professor

Locations

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Mei-fang Huang

Kaohsiung City, No. 20, Ln. 125, Wenbin Rd., Fengshan Dist.,, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Huang Mei-fang

Role: CONTACT

Phone: 866-978839897

Email: [email protected]

Facility Contacts

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Huang Mei-fang

Role: primary

Other Identifiers

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202000635B0

Identifier Type: -

Identifier Source: org_study_id