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

Shanghai Geping Information Technology Company

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Device: Welltang App

Study type: Interventional

Funder types: Industry

Identifiers

NCT02589730

IMME-6Y01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 3 patient groups

online mutual management

Experimental group

Description:

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

Treatment:

Device: Welltang App

online self-management

Experimental group

Description:

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

Treatment:

Device: Welltang App

hospital regular management

No Intervention group

Description:

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