Mobile Application for Self-Management of Type 2 Diabetes Mellitus

December 24, 2023 updated by: Supasuta Wongdama, Ramathibodi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • ฺBangkok, Thailand, 10170
        • Recruiting
        • Faculty of Medicine Ramathibodi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 3-6 months
The Thai version of the EQ-5D-5L Health Questionnaire
3-6 months
self-diabetes management
Time Frame: 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
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Study Director: Chutintorn Sriphrapradang, Ramathibodi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

November 22, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 16, 2023

First Posted (Actual)

December 20, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 24, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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