Diabetes Mellitus, Type 2NCT04271631
Integration of Education Based-Application and "CARE Coaching Model" in Management of Type 2 Diabetes Mellitus Patients Using Insulin
A study testing Mobile Application-Based Diabetes Education and Health Coaching in people with Diabetes Mellitus, Type 2, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Diabetes mellitus is increasing in incidence worldwide. The goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. Self-management becomes important in the management of diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Mobile Application-Based Diabetes Education and Health Coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Jun 2019to 31 May 2020
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus
- multiple daily insulin injection (basal and rapid, or mixed)
- 30 - 65 years old
- HbA1c > 8%
- Using smartphone in daily lives.
- Willing to follow the research by signing an informed consent
Who cannot join
- Patients with cognitive disease (such as dementia)
- Patients with hearing or sight problem
- Unable to live independently on daily basis
- Patients who have disease that may affect Hba1c such as hemolytic anemia, thalassemia
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Integrasi Edukasi Berbasis Aplikasi Dan "CARE Coaching Model" Pada Pengelolaan Pasien Diabetes Mellitus Tipe 2 Yang Menggunakan Insulin
Diabetes mellitus is increasing in incidence worldwide. The goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. Self-management becomes important in the management of diabetes mellitus. The use of mobile phone applications provides opportunities for the management of diabetics. In addition, health coaching is one of method used for empowering patients with chronic diseases, such as diabetes. This study aims to evaluate the impact of Mobile Application-Based Diabetes Education and health coaching in management of type 2 diabetes mellitus.
Read the detailed description
A randomized control trial, pre and post study involving 105 subjects randomized into 3 arms:
- Control : received conventional education group
- Intervention 1 : received conventional education group + mobile application-based diabetes education
- Intervention 2 : received mobile application-based diabetes education + health coaching
Conventional education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.
Mobile application-based diabetes education is using DM Educorner (Diabetes Mellitus Education Corner) availablle in Google PlayStore. Education contents was delivered in articles, video and infographics.
Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach.
Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Mobile Application-Based Diabetes Education, Health Coaching
- Keywords
- Type 2 diabetes mellitus, Mobile Application-Based Diabetes Education, Health Coaching
- 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 Application-Based Diabetes EducationOther
Also called DM EduCorner Application
Additional education was given using application, subjects were asked to open the application at least once a day
Health CoachingOther
Health coaching was given as face to face with a coach
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Received conventional education group |
| Intervention 1 | Experimental | Received conventional education group and Mobile Application-Based Diabetes Education Receives: Other: Mobile Application-Based Diabetes Education |
| Intervention 2 | Experimental | Received Mobile Application-Based Diabetes Education and Health Coaching Receives: Other: Mobile Application-Based Diabetes Education; Other: Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Hb1A1c at 3 months
Glycemic control
Measured: 3 months
Secondary outcomes (9)
Change from Baseline Fasting plasma glucose at 3 months
Glycemic control
Measured: 3 months after intervention
Change from Baseline 2 hours-post prandial plasma glucose at 3 months
Glycemic control
Measured: 3 months after intervention
Change from Baseline Total cholesterol at 3 months
Diabetes Mellitus control
Measured: 3 months after intervention
Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months
Diabetes Mellitus control
Measured: 3 months after intervention
Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months
Diabetes Mellitus control
Measured: 3 months after intervention
Change from Baseline Triglycerides at 3 months
Diabetes Mellitus control
Measured: 3 months after intervention
Mean of intake calories from food Record
mean calorief from diet intake in 3 days
Measured: at baseline, 3 months after intervention
Global Physical Activities Questionnaire
Questionnaire about physical activities in whole one week. Divided into 3 categories: low, moderate, high. Every categories describe duration and numbers of day being active during 1 weeks and not for judging it is good or worse.
Measured: at baseline, 3 and 6 months after intervention
Self-Monitoring Blood Glucose
Notes of daily blood glucose
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start12 Jun 2019
- Primary completion31 Jan 2020
- Study completion31 May 2020 (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.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD, Universitas Indonesia
- Investigators
- Pradana Soewondo, Prof, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271631
- Sponsor's protocol ID
- PS001
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrasi Edukasi Berbasis Aplikasi Dan "CARE Coaching Model" Pada Pengelolaan Pasien Diabetes Mellitus Tipe 2 Yang Menggunakan Insulin
- ClinicalTrials.gov ID
- NCT04271631
- Acronym / sponsor ID
- PS001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, Mobile Application-Based Diabetes Education, Health Coaching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 17 Feb 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.
Diabetes mellitus is increasing in incidence worldwide. The goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. Self-management becomes important in the management of diabetes mellitus. The use of mobile phone applications provides opportunities for the management of diabetics. In addition, health coaching is one of method used for empowering patients with chronic diseases, such as diabetes. This study aims to evaluate the impact of Mobile Application-Based Diabetes Education and health coaching in management of type 2 diabetes mellitus.
Detailed description
A randomized control trial, pre and post study involving 105 subjects randomized into 3 arms:
- Control : received conventional education group
- Intervention 1 : received conventional education group + mobile application-based diabetes education
- Intervention 2 : received mobile application-based diabetes education + health coaching
Conventional education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.
Mobile application-based diabetes education is using DM Educorner (Diabetes Mellitus Education Corner) availablle in Google PlayStore. Education contents was delivered in articles, video and infographics.
Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach.
Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Received conventional education group |
| Intervention 1 | Experimental | Other: Mobile Application-Based Diabetes EducationReceived conventional education group and Mobile Application-Based Diabetes Education |
| Intervention 2 | Experimental | Other: Mobile Application-Based Diabetes Education, Other: Health CoachingReceived Mobile Application-Based Diabetes Education and Health Coaching |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 Diabetes Mellitus
- multiple daily insulin injection (basal and rapid, or mixed)
- 30 - 65 years old
- HbA1c > 8%
- Using smartphone in daily lives.
Key exclusion criteria (4 listed)
- Patients with cognitive disease (such as dementia)
- Patients with hearing or sight problem
- Unable to live independently on daily basis
- Patients who have disease that may affect Hba1c such as hemolytic anemia, thalassemia
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 Application-Based Diabetes EducationAlso: DM EduCorner ApplicationAdditional education was given using application, subjects were asked to open the application at least once a day | Other | Intervention 1, Intervention 2 |
| Health CoachingHealth coaching was given as face to face with a coach | Other | Intervention 2 |
Primary outcome
Change from Baseline Hb1A1c at 3 months
Time frame: 3 months
Glycemic control
9 secondary outcomes
Change from Baseline Fasting plasma glucose at 3 months
Time frame: 3 months after intervention
Change from Baseline 2 hours-post prandial plasma glucose at 3 months
Time frame: 3 months after intervention
Change from Baseline Total cholesterol at 3 months
Time frame: 3 months after intervention
Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months
Time frame: 3 months after intervention
Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months
Time frame: 3 months after intervention
Change from Baseline Triglycerides at 3 months
Time frame: 3 months after intervention
Mean of intake calories from food Record
Time frame: at baseline, 3 months after intervention
Global Physical Activities Questionnaire
Time frame: at baseline, 3 and 6 months after intervention
Self-Monitoring Blood Glucose
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
Pradana Soewondo, Prof principal investigator
Fakultas Kedokteran Universitas Indonesia
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-Based Diabetes Education and Health Coaching in people with Diabetes Mellitus, Type 2, run by Universitas Indonesia at 1 site in Indonesia.
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 6 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 17 Feb 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 Indonesia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Hb1A1c at 3 months (time frame: 3 months). 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 17 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.