Mobile Application for Self-Management of Type 2 Diabetes Mellitus

NCT06176703 | Unknown DMC

• 1 other identifier: 5370
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Glycemic control

  HbA1c

  3-6 months

• Glycemic control

  Fasting blood sugar

  3-6 months

Secondary Outcomes (2)

• self-diabetes management

  3-6 months

• Quality of life

  3-6 months

Study Arms (2)

Standard treatment with mobile application in diabetes mellitus patients

EXPERIMENTAL

Device: mobile application

standard treatment without mobile application in diabetes mellitus patients

NO INTERVENTION

Interventions

mobile application DEVICE

using mobile application along with standard treatment of diabetes mellitus

Standard treatment with mobile application in diabetes mellitus patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital

ฺBangkok, 10170, Thailand

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chutintorn Sriphrapradang

  Ramathibodi Hospital

  STUDY DIRECTOR

Central Study Contacts

Supasuta Wongdama, Fellowship

CONTACT

0905754190; poytriplet@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 20, 2023
• Study Start: November 22, 2023
• Primary Completion: June 30, 2025
• Study Completion: November 22, 2025
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)