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

Diabetes Mellitus Clinical Trial

Official title:

Individualized Management Based on Mobile Phone Platform in Diabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02589730
• Other study ID #: IMME-6Y01
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2015
• Last updated: October 27, 2015
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2015
• Source: Shanghai Geping Information Technology Company
• Contact: Lei Zhang, MM
• Phone: +86-18930173806
• Email: stonez78[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Welltang App
This App is a large platform of individualized diabetic management

Locations

Country	Name	City	State
China	Shanghai Six People`s Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Geping Information Technology Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in scores measured by SDSCA		six months	No
Other	change in scores measured by DES-SF		six months	No
Other	change in scores measured by Morisky		six months	No
Other	change in scores measured by self distress scale		six months	No
Other	change in scores measured by self anxiety scale		six months	No
Primary	change in glycated hemoglobin levels		six months	No
Secondary	change in lipid profile levels		six months	No
Secondary	change of urinary albumin creatinine rate		six months	No
Secondary	change of hepatic function		six months	No
Secondary	change of blood creatine		six months	No
Secondary	change of blood urea nitrogen		six months	No
Secondary	change in scores measured by MKT		six months	No