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

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Device: Welltang App

• Registration Number: NCT02589730
• Lead Sponsor: Shanghai Geping Information Technology Company

Brief 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.

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 Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-27
• Last Update Submitted: 2015-10-27
• Study First Posted: 2015-10-28
• Last Update Posted: 2015-10-28
• Primary Completion: 2016-08
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 234

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
online mutual management	Welltang App	The patients received the online coaching of a doctor and diabetes educator via smart phone based welltang app.
online self-management	Welltang App	The patients received the online coaching of a doctor alone via smart phone based welltang app.

Primary Outcome Measures

Name	Time	Method
change in glycated hemoglobin levels	six months

Secondary Outcome Measures

Name	Time	Method
change of hepatic function	six months
change in lipid profile levels	six months
change of urinary albumin creatinine rate	six months
change of blood creatine	six months
change of blood urea nitrogen	six months
change in scores measured by MKT	six months

Trial Locations

Locations (1)

Shanghai Six People's Hospital; 🇨🇳 Shanghai, Shanghai, China