To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone ApplicationNCT04631159
Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application
A study testing Health2Sync app and report blood glucose data weekly and self-manage in people with To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application, run by Mei-fang Huang at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application
- What is being tested?
- Health2Sync app and report blood glucose data weekly and self-manage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of type2 diabetes
- Age 20 to 60 years old
Who cannot join
- No smartphone, cannot operation of smartphone
- Unable to move
- Use insulin pump
- Pregnant women
- Diagnosis neuropathy
- Diagnosis retinopathy
Show all 9Show fewer
- Diagnosis diabetic foot
- Diagnosis severe nephropathy ,
- Diagnosis severe liver disease Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Mei-fang Huang
Kaohsiung City, No. 20, Ln. 125, Wenbin Rd., Fengshan Dist.,, 830009
Huang Mei-fang, 077317123 ext. 2166, yopag2003@cgmh.org.tw
About this study
Official title: Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application:a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Health2Sync app and report blood glucose data weekly, self-manage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health2Sync app and report blood glucose data weeklyBehavioural
Patients will need to download and use the Health2Sync app and report blood glucose data weekly
self-manageOther
Patients will be asked to self-manage and there is no intervention during the tracking process
| Study group | Role | What they receive |
|---|---|---|
| Mobile app group | Experimental | 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. Receives: Behavioral: Health2Sync app and report blood glucose data weekly |
| Control group | Placebo comparator | 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. Receives: Other: self-manage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HbA1c through a mobile app.
Measured: Change from baseline HbA1c at 3 months
Secondary outcomes (1)
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.
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 May 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone ApplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei-fang Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei-fang Huang, Chang Gung Memorial Hospital
- Investigators
- Chang Nai-Jen, Study director, Kaohsiung Medical University Department of Sports Medicine professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631159
- Sponsor's protocol ID
- 202000635B0
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently in the submission stage ,and then share with other researchers after publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04631159
- Acronym / sponsor ID
- 202000635B0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mei-fang HuangUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Mobile app group | Experimental | Behavioral: Health2Sync app and report blood glucose data weeklyThey 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. |
| Control group | Placebo comparator | Other: self-managethey 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of type2 diabetes
- Age 20 to 60 years old
Key exclusion criteria (9 listed)
- No smartphone, cannot operation of smartphone
- Unable to move
- Use insulin pump
- Pregnant women
- Diagnosis neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health2Sync app and report blood glucose data weeklyPatients will need to download and use the Health2Sync app and report blood glucose data weekly | Behavioural | Mobile app group |
| self-managePatients will be asked to self-manage and there is no intervention during the tracking process | Other | Control group |
Primary outcome
Change from baseline HbA1c through a mobile app.
Time frame: Change from baseline HbA1c at 3 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No. Currently in the submission stage ,and then share with other researchers after publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Nai-Jen study director
Kaohsiung Medical University Department of Sports Medicine professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health2Sync app and report blood glucose data weekly and self-manage in people with To Investigate the Effectiveness of Health Management of Glycemic Control and Physical Activity in Type 2 Diabetes Mellitus Using Smartphone Application, run by Mei-fang Huang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Mei-fang (866-978839897, yopag2003@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline HbA1c through a mobile app. (time frame: Change from baseline HbA1c at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.