- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04631159
Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application
Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application:a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huang Mei-fang
- Phone Number: 866-978839897
- Email: yopag2003@cgmh.org.tw
Study Locations
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No. 20, Ln. 125, Wenbin Rd., Fengshan Dist.,
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Kaohsiung City, No. 20, Ln. 125, Wenbin Rd., Fengshan Dist.,, Taiwan, 830009
- Recruiting
- Mei-fang Huang
-
Contact:
- Huang Mei-fang
- Phone Number: 2166 077317123
- Email: yopag2003@cgmh.org.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Patients will need to download and use the Health2Sync app and report blood glucose data weekly
|
Placebo Comparator: 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.
|
Patients will be asked to self-manage and there is no intervention during the tracking process
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline HbA1c through a mobile app.
Time Frame: Change from baseline HbA1c at 3 months
|
Change from baseline HbA1c at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of participants who have related every day steps as assessed by Mi Smart Band 4.
Time Frame: Change from baseline at 3 months
|
The number of participants who have related per day steps as assessed by Mi Smart Band 4. Achieve the goal value of 7500 steps per day.
|
Change from baseline at 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chang Nai-Jen, Kaohsiung Medical University Department of Sports Medicine professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202000635B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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