Mobile Application for Self-Management of Type 2 Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: mobile application

• Registration Number: NCT06176703
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-22
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-16
• Study First Posted: 2023-12-20
• Last Update Submitted: 2023-12-24
• Last Update Posted: 2023-12-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-11-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment with mobile application in diabetes mellitus patients	mobile application	-

Primary Outcome Measures

Name	Time	Method
Glycemic control	3-6 months	Fasting blood sugar

Secondary Outcome Measures

Name	Time	Method
self-diabetes management	3-6 months	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
Quality of life	3-6 months	The Thai version of the EQ-5D-5L Health Questionnaire

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital; 🇹🇭 ฺBangkok, Thailand