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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Health2Sync app and report blood glucose data weekly
self-manage
Sponsored by
Mei-fang Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mei-fang HuangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mobile app group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline HbA1c through a mobile app.

Secondary Outcome Measures

The number of participants who have related every day steps as assessed by Mi Smart Band 4.
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.

Full Information

First Posted
November 3, 2020
Last Updated
November 16, 2020
Sponsor
Mei-fang Huang
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1. Study Identification

Unique Protocol Identification Number
NCT04631159
Brief Title
Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application
Official Title
Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application:a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mei-fang Huang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile app group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health2Sync app and report blood glucose data weekly
Intervention Description
Patients will need to download and use the Health2Sync app and report blood glucose data weekly
Intervention Type
Other
Intervention Name(s)
self-manage
Intervention Description
Patients will be asked to self-manage and there is no intervention during the tracking process
Primary Outcome Measure Information:
Title
Change from baseline HbA1c through a mobile app.
Time Frame
Change from baseline HbA1c at 3 months
Secondary Outcome Measure Information:
Title
The number of participants who have related every day steps as assessed by Mi Smart Band 4.
Description
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.
Time Frame
Change from baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Mei-fang
Phone
866-978839897
Email
yopag2003@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Nai-Jen
Organizational Affiliation
Kaohsiung Medical University Department of Sports Medicine professor
Official's Role
Study Director
Facility Information:
Facility Name
Mei-fang Huang
City
Kaohsiung City
State/Province
No. 20, Ln. 125, Wenbin Rd., Fengshan Dist.,
ZIP/Postal Code
830009
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Mei-fang
Phone
077317123
Ext
2166
Email
yopag2003@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently in the submission stage ,and then share with other researchers after publication

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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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