Diabetes MellitusNCT02589730
Effect of Smart Phone Application on the Individualized Management of Chinese Diabetic Patients
A study testing Welltang App in people with Diabetes Mellitus, run by Shanghai Geping Information Technology Company at 1 site in China.
Trial summary
The purpose of this study was to explore a model suitable for the individualized diabetic management based on the mobile application coaching and demonstrate its effect among the diabetic mellitus population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Welltang App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of DM for more than 6 months;
- Glycated hemoglobin more than or equal to 8% within 3 months;
- Age:18-65 years.
Who cannot join
- Insulin pump users;
- Pregnant;
- Active substance, alcohol, or drug abuser;
- Psychotic or schizophrenic under active care;
- Severe hearing or visual impairment and other complications;
- Drug users (such as glucocorticoid or thyroid hormone) 3 months before the enrollment;
- No smartphone access.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Six People's Hospital
Shanghai, Shanghai Municipality, 200233
Lei Zhang, MM, +86-18930173806, stonez78@hotmail.com
About this study
Official title: Individualized Management Based on Mobile Phone Platform in Diabetic Patients
The purpose of this study was to explore a model suitable for the individualized diabetic management based on the mobile application coaching and demonstrate its effect among the diabetic mellitus population.
Read the detailed description
The enrolled patients will be randomly divided into three groups: group of online self management, group of online mutual management and the control group. The estimated sample size was 78 patients for each group. All the patients attend two follow-up visits at the hospital, after 3 and 6 months. The data will be collected by a full-time recorder and analyzed using specific statistical software. The enumeration data are analyzed by chi-square test, while the measurement data are analyzed by one-way ANOVA.
- Conditions
- Diabetes Mellitus
- Being tested
- Welltang App
- Keywords
- Smartphone app, diabetic management, lifestyle behaviors, medication management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Welltang AppDevice
This App is a large platform of individualized diabetic management
| Study group | Role | What they receive |
|---|---|---|
| online mutual management | Experimental | The patients received the online coaching of a doctor and diabetes educator via smart phone based welltang app. Receives: Device: Welltang App |
| online self-management | Experimental | The patients received the online coaching of a doctor alone via smart phone based welltang app. Receives: Device: Welltang App |
| hospital regular management | No intervention | The patients received usual care and did not use smart phone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glycated hemoglobin levels
Measured: six months
Secondary outcomes (6)
change in lipid profile levels
Measured: six months
change of urinary albumin creatinine rate
Measured: six months
change of hepatic function
Measured: six months
change of blood creatine
Measured: six months
change of blood urea nitrogen
Measured: six months
change in scores measured by MKT
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Geping Information Technology Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589730
- Sponsor's protocol ID
- IMME-6Y01
- Status last verified
- Oct 2015
- First submitted
- 16 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang L, He X, Shen Y, Yu H, Pan J, Zhu W, Zhou J, Bao Y. Effectiveness of Smartphone App-Based Interactive Management on Glycemic Control in Chinese Patients With Poorly Controlled Diabetes: Randomized Controlled Trial. J Med Internet Res. 2019 Dec 9;21(12):e15401. doi: 10.2196/15401.
PubMed 31815677
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Management Based on Mobile Phone Platform in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02589730
- Acronym / sponsor ID
- IMME-6Y01
- Conditions
- Diabetes Mellitus
- Keywords
- Smartphone app, diabetic management, lifestyle behaviors, medication management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Shanghai Geping Information Technology CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- 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.
The purpose of this study was to explore a model suitable for the individualized diabetic management based on the mobile application coaching and demonstrate its effect among the diabetic mellitus population.
Detailed description
The enrolled patients will be randomly divided into three groups: group of online self management, group of online mutual management and the control group. The estimated sample size was 78 patients for each group. All the patients attend two follow-up visits at the hospital, after 3 and 6 months. The data will be collected by a full-time recorder and analyzed using specific statistical software. The enumeration data are analyzed by chi-square test, while the measurement data are analyzed by one-way ANOVA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| online mutual management | Experimental | Device: Welltang AppThe patients received the online coaching of a doctor and diabetes educator via smart phone based welltang app. |
| online self-management | Experimental | Device: Welltang AppThe patients received the online coaching of a doctor alone via smart phone based welltang app. |
| hospital regular management | No intervention | –The patients received usual care and did not use smart phone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physician diagnosis of DM for more than 6 months;
- Glycated hemoglobin more than or equal to 8% within 3 months;
- Age:18-65 years.
Key exclusion criteria (7 listed)
- Insulin pump users;
- Pregnant;
- Active substance, alcohol, or drug abuser;
- Psychotic or schizophrenic under active care;
- Severe hearing or visual impairment and other complications;
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 |
|---|---|---|
| Welltang AppThis App is a large platform of individualized diabetic management | Device | online mutual management, online self-management |
Primary outcome
change in glycated hemoglobin levels
Time frame: six months
6 secondary outcomes
change in lipid profile levels
Time frame: six months
change of urinary albumin creatinine rate
Time frame: six months
change of hepatic function
Time frame: six months
change of blood creatine
Time frame: six months
change of blood urea nitrogen
Time frame: six months
change in scores measured by MKT
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Derived from this study: PubMed 31815677Zhang L, He X, Shen Y, Yu H, Pan J, Zhu W, Zhou J, Bao Y. Effectiveness of Smartphone App-Based Interactive Management on Glycemic Control in Chinese Patients With Poorly Controlled Diabetes: Randomized Controlled Trial. J Med Internet Res. 2019 Dec 9;21(12):e15401. doi: 10.2196/15401.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Welltang App in people with Diabetes Mellitus, run by Shanghai Geping Information Technology Company at 1 site in China.
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 3 inclusion and 7 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 28 Oct 2015. 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 China. 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. 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 Lei Zhang, MM (+86-18930173806, stonez78@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in glycated hemoglobin levels (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02589730, which also lists 1 linked publication.
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 28 Oct 2015.