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Status unknownNCT02589730Updated Oct 28, 2015

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

An interventional study of Welltang App in Diabetes Mellitus, sponsored by Shanghai Geping Information Technology Company. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-28.

Sponsored by Shanghai Geping Information Technology Company · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Smartphone app
  • diabetic management
  • lifestyle behaviors
  • medication management
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 234 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Shanghai Geping Information Technology Company as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
234 participants (estimated)

Study arms

  • 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

  • Experimental
    online self-management

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

    Device: Welltang App

  • No intervention
    hospital regular management

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

Interventions

  • DeviceWelltang App

    This App is a large platform of individualized diabetic management

06

What researchers measure

Primary outcomes

  1. change in glycated hemoglobin levels

    Time frame: six months

Secondary outcomes

  1. change in lipid profile levels

    Time frame: six months

  2. change of urinary albumin creatinine rate

    Time frame: six months

  3. change of hepatic function

    Time frame: six months

  4. change of blood creatine

    Time frame: six months

  5. change of blood urea nitrogen

    Time frame: six months

  6. change in scores measured by MKT

    Time frame: six months

Other outcomes

  1. change in scores measured by SDSCA

    Time frame: six months

  2. change in scores measured by DES-SF

    Time frame: six months

  3. change in scores measured by Morisky

    Time frame: six months

  4. change in scores measured by self distress scale

    Time frame: six months

  5. change in scores measured by self anxiety scale

    Time frame: six months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Six People's Hospital
    Shanghai, Shanghai 200233, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 31815677 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02589730
Lead sponsor
Shanghai Geping Information Technology Company
Responsible party
Sponsor
First posted
Oct 28, 2015
Start date
Oct 2015
Primary completion
Aug 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Oct 28, 2015

Study contacts

Lei Zhang, MM
Contact
stonez78@hotmail.com
+86-18930173806

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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