Development of Diabetes Mobile Application

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Development of Diabetes Mobile Application "MyD App" To Improve Patient's Knowledge, Compliance and Control: An Interventional Study Among Uncontrolled Type 2 Diabetes Mellitus Patients in Kedah, Malaysia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686201
• Other study ID #: Diabetes Apps
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: National University of Malaysia
• Contact: MOHD ROHAIZAT HASSAN, PhD
• Phone: +60126343303
• Email: rohaizat[@]ppukm.ukm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this study is to measure the effectiveness of a diabetes mobile application for improving patient's knowledge, compliance and diabetes control among uncontrolled Type 2 Diabetes Mellitus mellitus patients in Kedah

Description:

Specific Objective

1. To develop and validate a diabetes mobile-app (MyD-App) for patients with uncontrolled Type 2 Diabetes Mellitus.

2. To measure the effectiveness of a diabetes mobile application for improving knowledge, compliance and control using the newly developed and validated MyD-App among patients with uncontrolled Type 2 Diabetes Mellitus.

Hypothesis

1. There is an increased in patient's knowledge on diabetes after MyD-App usage.

2. There is an increased in patient's compliance on medication and treatment after MyD-App usage.

3. There is a diabetes control improvement (HbA1C < 6.5% or HbA1C reduction ≥ 1%) among Type 2 Diabetes Mellitus patients in Kedah after MyD-App usage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years old

• Diagnosed with type 2 diabetes mellitus by a registered medical doctor.

• Registered and actively follow up in the health clinics at selected districts. (actively follow up: follow up at the clinic for at least once in a year).

• Own a smartphone with the Android platform.

• HbA1C >7%

Exclusion Criteria:

• GDM

• Illiterate

• Anemia / Thalassemia

• Not agree to be the sample for the study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• Diabetes Mobile Application
incorporating mobile application usage in managing diabetes mellitus patient in health clinics

Locations

Country	Name	City	State
Malaysia	Jabatan Kesihatan Negeri Kedah	Alor Setar	Kedah

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application	Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application (assessment using Michigan Diabetes Knowledge Test Questionnaire)	6 months
Primary	Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application	Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application (assessment using Malaysia Medication Adherence Assessment Tool (MyMAAT) for diabetic patients)	6 months
Primary	Percentage of uncontrolled Diabetes Mellitus patients who have good control diabetes after using Diabetes Mobile Application	Percentage of uncontrolled Diabetes Mellitus patients who have good control diabetes (HbA1C 7% or more than 1% reduction of HbA1C) after using Diabetes Mobile Application	6 months