Type 2 Diabetes MellitusPhase 3NCT04686201
Development of Diabetes Mobile Application
A Phase 3 study testing Diabetes Mobile Application in people with Type 2 Diabetes Mellitus, run by National University of Malaysia at 1 site in Malaysia.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Diabetes Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- GDM
- Illiterate
- Anemia / Thalassemia
- Not agree to be the sample for the study
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Jabatan Kesihatan Negeri Kedah
Alor Star, Kedah, 05400
MOHD NAZRIN JAMHARI, MPH, 0173287707, drmohdnazrin@gmail.com
About this study
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
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
Read the detailed description
Specific Objective
- To develop and validate a diabetes mobile-app (MyD-App) for patients with uncontrolled Type 2 Diabetes Mellitus.
- 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
- There is an increased in patient's knowledge on diabetes after MyD-App usage.
- There is an increased in patient's compliance on medication and treatment after MyD-App usage.
- 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Diabetes Mobile Application
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Mobile ApplicationDevice
incorporating mobile application usage in managing diabetes mellitus patient in health clinics
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Device: Diabetes Mobile Application |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
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)
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Aug 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MOHD ROHAIZAT HASSAN, PhD, Principal investigator, Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686201
- Sponsor's protocol ID
- Diabetes Apps
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04686201
- Acronym / sponsor ID
- Diabetes Apps
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To develop and validate a diabetes mobile-app (MyD-App) for patients with uncontrolled Type 2 Diabetes Mellitus.
- 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
- There is an increased in patient's knowledge on diabetes after MyD-App usage.
- There is an increased in patient's compliance on medication and treatment after MyD-App usage.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: Diabetes Mobile Application |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (4 listed)
- GDM
- Illiterate
- Anemia / Thalassemia
- Not agree to be the sample for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Mobile Applicationincorporating mobile application usage in managing diabetes mellitus patient in health clinics | Device | intervention group |
Primary outcome
Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application
Time frame: 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 compliance after using Diabetes Mobile Application
Time frame: 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 control diabetes after using Diabetes Mobile Application
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MOHD ROHAIZAT HASSAN, PhD principal investigator
Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diabetes Mobile Application in people with Type 2 Diabetes Mellitus, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MOHD ROHAIZAT HASSAN, PhD (+60126343303, rohaizat@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of uncontrolled Diabetes Mellitus patients who have good knowledge after using Diabetes Mobile Application (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.