Effect of Smart Phone Application on the Individualized Management of Chinese Diabetic Patients

NCT ID: NCT02589730

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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online mutual management

The patients received the online coaching of a doctor and diabetes educator via smart phone based welltang app.

Group Type EXPERIMENTAL

Welltang App

Intervention Type DEVICE

This App is a large platform of individualized diabetic management

online self-management

The patients received the online coaching of a doctor alone via smart phone based welltang app.

Group Type EXPERIMENTAL

Welltang App

Intervention Type DEVICE

This App is a large platform of individualized diabetic management

hospital regular management

The patients received usual care and did not use smart phone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Welltang App

This App is a large platform of individualized diabetic management

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Physician diagnosis of DM for more than 6 months;
* Glycated hemoglobin more than or equal to 8% within 3 months;
* Age:18-65 years.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Geping Information Technology Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Six People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Zhang, MM

Role: CONTACT

+86-18930173806

Facility Contacts

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Lei Zhang, MM

Role: primary

+86-18930173806

References

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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.

Reference Type DERIVED
PMID: 31815677 (View on PubMed)

Other Identifiers

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IMME-6Y01

Identifier Type: -

Identifier Source: org_study_id

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