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

October 27, 2015 updated by: Shanghai Geping Information Technology Company

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • Shanghai Six People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: online mutual management
The patients received the online coaching of a doctor and diabetes educator via smart phone based welltang app.
Device: Welltang App
This App is a large platform of individualized diabetic management
EXPERIMENTAL: online self-management
The patients received the online coaching of a doctor alone via smart phone based welltang app.
Device: Welltang App
This App is a large platform of individualized diabetic management
NO_INTERVENTION: hospital regular management
The patients received usual care and did not use smart phone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in glycated hemoglobin levels
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in lipid profile levels
Time Frame: six months
six months
change of urinary albumin creatinine rate
Time Frame: six months
six months
change of hepatic function
Time Frame: six months
six months
change of blood creatine
Time Frame: six months
six months
change of blood urea nitrogen
Time Frame: six months
six months
change in scores measured by MKT
Time Frame: six months
six months

Other Outcome Measures

Outcome Measure
Time Frame
change in scores measured by SDSCA
Time Frame: six months
six months
change in scores measured by DES-SF
Time Frame: six months
six months
change in scores measured by Morisky
Time Frame: six months
six months
change in scores measured by self distress scale
Time Frame: six months
six months
change in scores measured by self anxiety scale
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Geping Information Technology Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

October 1, 2016

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (ESTIMATE)

October 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IMME-6Y01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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