Mobile Application for Self-Management of Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The goal of this Randomized Controlled Trial is to study the effect of mobile Application on glycemic control of type2 diabetes mellitus. The main questions aim to answer are: The effect of mobile application on glycemic control and quality of life of diabetes mellitus patients The satisfaction of mobile application of diabetes mellitus patients who used it Participants will be received education about diabetes mellitus and separated into two groups, intervention group(using mobile application) and control group(not using mobile application but also receive standard treatment of diabetes mellitus. Researchers will compare intervention group to control group about glycemic control including HbA1c, complications of diabetes mellitus etc. and quality of life.

Official Title
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Mobile Application for Self-Management of Type 2 Diabetes Mellitus: Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: mobile application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type2 diabetes mellitus who have HbA1c above 7% Can use application on smartphone age 18 years old or more (relatives are accept if participants have age more than 65 years old and cannot use smartphone) consent to participate the research Exclusion Criteria: refuse to participate the research pregnancy using continuous glucose monitoring system or insulin pump disability in sight or hearing have been using the mobile application(RAMAdiabetes) in the past

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard treatment with mobile application in diabetes mellitus patients<br> | Device: mobile application<br>* using mobile application along with standard treatment of diabetes mellitus<br>|
| No Intervention: standard treatment without mobile application in diabetes mellitus patients<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | HbA1c | 3-6 months | 
| Glycemic control | Fasting blood sugar | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-diabetes management | The Thai-Diabetes Management of Self-Efficacy Scale(T-DMSES), total score range from 19 to 95 points(minimum to maximum), each question has 1 to 5 points, higher scores mean better self diabetes management | 3-6 months | 
| Quality of life | The Thai version of the EQ-5D-5L Health Questionnaire | 3-6 months |