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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Individualized Management Based on Mobile Phone Platform in Diabetic Patients

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Welltang App


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: online mutual management<br>The patients received the online coaching of a doctor and diabetes educator via smart phone based welltang app. | Device: Welltang App<br>* This App is a large platform of individualized diabetic management<br>|
| Experimental: online self-management<br>The patients received the online coaching of a doctor alone via smart phone based welltang app. | Device: Welltang App<br>* This App is a large platform of individualized diabetic management<br>|
| No Intervention: hospital regular management<br>The patients received usual care and did not use smart phone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glycated hemoglobin levels |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| change in scores measured by MKT |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone app, diabetic management, lifestyle behaviors, medication management