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

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ClinicalTrials.gov Identifier: NCT04631159
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Mei-fang Huang, Chang Gung Memorial Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application Behavioral: Health2Sync app and report blood glucose data weekly Other: self-manage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application:a Randomized Controlled Trial
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Behavioral: Health2Sync app and report blood glucose data weekly
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.
 Other: self-manage
Patients will be asked to self-manage and there is no intervention during the tracking process


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline HbA1c through a mobile app. [ Time Frame: Change from baseline HbA1c at 3 months ]

Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631159


Contacts
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Contact: Huang Mei-fang 866-978839897 yopag2003@cgmh.org.tw

Locations
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Taiwan
Mei-fang Huang Recruiting
Kaohsiung City, No. 20, Ln. 125, Wenbin Rd., Fengshan Dist.,, Taiwan, 830009
Contact: Huang Mei-fang    077317123 ext 2166    yopag2003@cgmh.org.tw   
Sponsors and Collaborators
Mei-fang Huang
Investigators
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Study Director: Chang Nai-Jen Kaohsiung Medical University Department of Sports Medicine professor
More Information
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Responsible Party: Mei-fang Huang, ChangGungMH Certified Diabetes Educator, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04631159    
Other Study ID Numbers: 202000635B0
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently in the submission stage ,and then share with other researchers after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases