Effect of Smart Phone Application on the Individualized Management of Chinese Diabetic Patients
Individualized Management Based on Mobile Phone Platform in Diabetic Patients
1 other identifier
interventional
234
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 16, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 28, 2015
October 1, 2015
10 months
October 16, 2015
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in glycated hemoglobin levels
six months
Secondary Outcomes (6)
change in lipid profile levels
six months
change of urinary albumin creatinine rate
six months
change of hepatic function
six months
change of blood creatine
six months
change of blood urea nitrogen
six months
- +1 more secondary outcomes
Other Outcomes (5)
change in scores measured by SDSCA
six months
change in scores measured by DES-SF
six months
change in scores measured by Morisky
six months
- +2 more other outcomes
Study Arms (3)
online mutual management
EXPERIMENTALThe patients received the online coaching of a doctor and diabetes educator via smart phone based welltang app.
online self-management
EXPERIMENTALThe patients received the online coaching of a doctor alone via smart phone based welltang app.
hospital regular management
NO INTERVENTIONThe patients received usual care and did not use smart phone.
Interventions
This App is a large platform of individualized diabetic management
Eligibility Criteria
You may qualify if:
- Physician diagnosis of DM for more than 6 months;
- Glycated hemoglobin more than or equal to 8% within 3 months;
- Age:18-65 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Six People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Related Publications (1)
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.
PMID: 31815677DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2015
First Posted
October 28, 2015
Study Start
October 1, 2015
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
October 28, 2015
Record last verified: 2015-10