Development of Diabetes Mobile Application

Phase 3

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT04686201
• Lead Sponsor: National University of Malaysia

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2019-08-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2020-12-24
• Last Update Submitted: 2020-12-24
• Study First Posted: 2020-12-28
• Last Update Posted: 2020-12-28
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of uncontrolled Diabetes Mellitus patients who have good compliance after using Diabetes Mobile Application	6 months	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)
Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application	6 months	Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application (assessment using Michigan Diabetes Knowledge Test Questionnaire)
Percentage of uncontrolled Diabetes Mellitus patients who have good control diabetes after using Diabetes Mobile Application	6 months	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

Trial Locations

Locations (1)

Jabatan Kesihatan Negeri Kedah; 🇲🇾 Alor Setar, Kedah, Malaysia