Clinical trial NCT02589730: Effect of Smart Phone Application on the Individualized Management of Chinese Diabetic Patients
Official title: Individualized Management Based on Mobile Phone Platform in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Smartphone app
diabetic management
lifestyle behaviors
medication management
Lead sponsor: Shanghai Geping Information Technology Company
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in glycated hemoglobin levels
timeFrame: six months
Secondary outcomes:
measure: change in lipid profile levels
timeFrame: six months
measure: change of urinary albumin creatinine rate
timeFrame: six months
measure: change of hepatic function
timeFrame: six months
measure: change of blood creatine
timeFrame: six months
measure: change of blood urea nitrogen
timeFrame: six months
measure: change in scores measured by MKT
timeFrame: six months
Other outcomes:
measure: change in scores measured by SDSCA
timeFrame: six months
measure: change in scores measured by DES-SF
timeFrame: six months
measure: change in scores measured by Morisky
timeFrame: six months
measure: change in scores measured by self distress scale
timeFrame: six months
measure: change in scores measured by self anxiety scale
timeFrame: six months
Locations:
city: Shanghai
country: China
facility: Shanghai Six People's Hospital
state: Shanghai
Study officials:
References:
citation: 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.