Diabetes Mellitus, Type 2NCT06176703
Mobile Application for Self-Management of Type 2 Diabetes Mellitus
A study testing mobile application in people with Diabetes Mellitus, Type 2, run by Ramathibodi Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteThailand
- Study dates
- 22 Nov 2023to 22 Nov 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ramathibodi Hospital
ฺBangkok, 10170
Supasuta Wongdama, 0905754190, poytriplet@gmail.com
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 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.
mobile applicationDevice
using mobile application along with standard treatment of diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment with mobile application in diabetes mellitus patients | Experimental | Not described Receives: Device: mobile application |
| standard treatment without mobile application in diabetes mellitus patients | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
HbA1c
Measured: 3-6 months
Glycemic control
Fasting blood sugar
Measured: 3-6 months
Secondary outcomes (2)
self-diabetes management
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
Measured: 3-6 months
Quality of life
The Thai version of the EQ-5D-5L Health Questionnaire
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start22 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion22 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supasuta Wongdama, Ramathibodi Hospital
- Investigators
- Chutintorn Sriphrapradang, Study director, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176703
- Sponsor's protocol ID
- 5370
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application for Self-Management of Type 2 Diabetes Mellitus: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06176703
- Acronym / sponsor ID
- 5370
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 22 Nov 2025 (estimated)
- First posted
- 20 Dec 2023 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment with mobile application in diabetes mellitus patients | Experimental | Device: mobile application |
| standard treatment without mobile application in diabetes mellitus patients | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| mobile applicationusing mobile application along with standard treatment of diabetes mellitus | Device | Standard treatment with mobile application in diabetes mellitus patients |
Primary outcome
Glycemic control
Time frame: 3-6 months
HbA1c
Glycemic control
Time frame: 3-6 months
Fasting blood sugar
2 secondary outcomes
self-diabetes management
Time frame: 3-6 months
Quality of life
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Chutintorn Sriphrapradang study director
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile application in people with Diabetes Mellitus, Type 2, run by Ramathibodi Hospital at 1 site in Thailand.
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 4 inclusion and 5 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 29 Dec 2023. 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 Thailand. 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.
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 Supasuta Wongdama, Fellowship (0905754190, poytriplet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 3-6 months). The study lists 2 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 29 Dec 2023.