Diabetes Mellitus, Type 2NCT03468283
Smartphone Application for Type 2 Diabetes
A study testing mobile application for diabetes in people with Diabetes Mellitus, Type 2, run by Kangbuk Samsung Hospital.
Trial summary
Since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement and management of living habits are as significant as medical care with regard to the disease. In addition, this is regarded as the most effective method for prevention and treatment of diabetes. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- mobile application for diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2012to 13 Mar 2013
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged ≥ 19 years;
- android smartphone users;
- no changes in medication for diabetes for at least 6 months;
- HbA1c levels ≥6.5% within the last 3 months.
Who cannot join
- currently had serious concomitant disease other than diabetes (n=1); malignancy-related histories on admission, myocardial infarction, cerebral infarction or organ transplantation;
- pregnant or had plans for pregnancy within 6 months;
- plans to participate in other clinical studies or illiteracy.
About this study
Official title: A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of Smartphone Application in Patients With Type 2 Diabetes
Since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement and management of living habits are as significant as medical care with regard to the disease. In addition, this is regarded as the most effective method for prevention and treatment of diabetes. However, many diabetic patients are now reported to lack proper management in Korea with a low level of compliance with treatment instruction. In that sense, it is urgently necessary to develop a program in which diabetic patients are able to effectively manage their own blood glucose at home, and to grasp the real state of self-blood glucose measurement. Accordingly, a system to manage diabetes using electronic equipment such as mobile phone or the Internet is currently being developed and studied, for the effective management of diabetes with the help of highly evolving information technology. These investigators have developed a diabetes management program that provides an optimal solution based on a mobile device and software, so that individual patients can undergo a regular blood glucose test and achieve improvement and constant management of living habits by being properly informed of how to manage diabetes. This clinical study was designed to evaluate the effectiveness and efficacy of the application through the comparison between usual medical care and additional care using the smartphone application, targeting patients with type 2 diabetes who lack blood glucose control. This study is targeted at the subjects who are being treated at this hospital's endocrinology, are using a smartphone, and voluntarily signed the informed consent form (ICF). The subjects who pass the subject eligibility evaluation provide information regarding assessment items and demographic information using the smartphone application and questionnaire. Based on the information given by subjects, the medical team offers a management system that supports and improves the existing treatment process of diabetes using the application developed on its own. The feasibility and effectiveness of the management using the application are evaluated through the result values of the laboratory tests performed during the subject's usual medical care.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- mobile application for diabetes
- Keywords
- Mobile healthcare, Health Services Research, Community Health Services, Diabetes self-management education
- 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 for diabetesOther
Intervention was mobile application and individualized regular message feedback sent by healthcare professionals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention was the addition of mobile healthcare-based diabetes self-management education, which consisted of "mobile application for diabetes" and individualized regular message feedback sent by healthcare professionals, to current diabetes management. Receives: Other: mobile application for diabetes |
| control | No intervention | Participants of control group maintained previous diabetes management in Kangbuk Samsung Hospital throughout this study. Providers were not involved with patient prescriptions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1c levels
serum glycated hemoglobin levels
Measured: at six months
Secondary outcomes (9)
body mass index
The changes in body mass index
Measured: at six months
blood pressure
The changes in blood pressure
Measured: at six months
serum triglyceride
The changes in serum triglyceride levels
Measured: at six months
serum high-density lipoprotein cholesterol
The changes in serum high-density lipoprotein cholesterol levels
Measured: at six months
serum low-density lipoprotein cholesterol
The changes in serum low-density lipoprotein cholesterol levels
Measured: at six months
Summary of Diabetes Self-Care Activities Questionnaire
scores of Summary of Diabetes Self-Care Activities Questionnaire to measure the current status of diabetic patients' self-care activities (diet, exercise, blood glucose, foot care, and smoking) with each scale of 0 to 7 points.
Measured: at six months
Audit of Diabetes Dependent Quality of Life
scores of Audit of Diabetes Dependent Quality of Life to measure effects of diabetes on the quality of patients' life with each scale of -9 to +3 points.
Measured: at six months
the Korean version of the Appraisal of Diabetes Scale
scores of the Korean version of the Appraisal of Diabetes Scale to measure how diabetic patients recognize about the disease with each scale of 1 to 5 points.
Measured: at six months
the Problem Areas in Diabetes
scores of the Problem Areas in Diabetes to measure level of stress related to diabetes with each scale of 0 to 4 points.
Measured: at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start7 Aug 2012
- Primary completion6 Feb 2013
- Study completion13 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol-Young Park, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468283
- Sponsor's protocol ID
- KBC12093
- Status last verified
- Mar 2018
- First submitted
- 1 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee DY, Yoo SH, Min KP, Park CY. Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial. JMIR Mhealth Uhealth. 2020 Sep 18;8(9):e19153. doi: 10.2196/19153.
PubMed 32945775
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of Smartphone Application in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03468283
- Acronym / sponsor ID
- KBC12093
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Mobile healthcare, Health Services Research, Community Health Services, Diabetes self-management education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 7 Aug 2012 (actual)
- Primary completion
- 6 Feb 2013 (actual)
- Study completion
- 13 Mar 2013 (actual)
- First posted
- 16 Mar 2018 (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.
Since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement and management of living habits are as significant as medical care with regard to the disease. In addition, this is regarded as the most effective method for prevention and treatment of diabetes. However, many diabetic patients are now reported to lack proper management in Korea with a low level of compliance with treatment instruction. In that sense, it is urgently necessary to develop a program in which diabetic patients are able to effectively manage their own blood glucose at home, and to grasp the real state of self-blood glucose measurement. Accordingly, a system to manage diabetes using electronic equipment such as mobile phone or the Internet is currently being developed and studied, for the effective management of diabetes with the help of highly evolving information technology. These investigators have developed a diabetes management program that provides an optimal solution based on a mobile device and software, so that individual patients can undergo a regular blood glucose test and achieve improvement and constant management of living habits by being properly informed of how to manage diabetes. This clinical study was designed to evaluate the effectiveness and efficacy of the application through the comparison between usual medical care and additional care using the smartphone application, targeting patients with type 2 diabetes who lack blood glucose control. This study is targeted at the subjects who are being treated at this hospital's endocrinology, are using a smartphone, and voluntarily signed the informed consent form (ICF). The subjects who pass the subject eligibility evaluation provide information regarding assessment items and demographic information using the smartphone application and questionnaire. Based on the information given by subjects, the medical team offers a management system that supports and improves the existing treatment process of diabetes using the application developed on its own. The feasibility and effectiveness of the management using the application are evaluated through the result values of the laboratory tests performed during the subject's usual medical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: mobile application for diabetesIntervention was the addition of mobile healthcare-based diabetes self-management education, which consisted of "mobile application for diabetes" and individualized regular message feedback sent by healthcare professionals, to current diabetes management. |
| control | No intervention | –Participants of control group maintained previous diabetes management in Kangbuk Samsung Hospital throughout this study. Providers were not involved with patient prescriptions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥ 19 years;
- android smartphone users;
- no changes in medication for diabetes for at least 6 months;
- HbA1c levels ≥6.5% within the last 3 months.
Key exclusion criteria (3 listed)
- currently had serious concomitant disease other than diabetes (n=1); malignancy-related histories on admission, myocardial infarction, cerebral infarction or organ transplantation;
- pregnant or had plans for pregnancy within 6 months;
- plans to participate in other clinical studies or illiteracy.
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 for diabetesIntervention was mobile application and individualized regular message feedback sent by healthcare professionals. | Other | Intervention |
Primary outcome
hemoglobin A1c levels
Time frame: at six months
serum glycated hemoglobin levels
9 secondary outcomes
body mass index
Time frame: at six months
blood pressure
Time frame: at six months
serum triglyceride
Time frame: at six months
serum high-density lipoprotein cholesterol
Time frame: at six months
serum low-density lipoprotein cholesterol
Time frame: at six months
Summary of Diabetes Self-Care Activities Questionnaire
Time frame: at six months
Audit of Diabetes Dependent Quality of Life
Time frame: at six months
the Korean version of the Appraisal of Diabetes Scale
Time frame: at six months
the Problem Areas in Diabetes
Time frame: at six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Derived from this study: PubMed 32945775Lee DY, Yoo SH, Min KP, Park CY. Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial. JMIR Mhealth Uhealth. 2020 Sep 18;8(9):e19153. doi: 10.2196/19153.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing mobile application for diabetes in people with Diabetes Mellitus, Type 2, run by Kangbuk Samsung Hospital.
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 3 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: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hemoglobin A1c levels (time frame: at six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468283, which also lists 1 linked publication.
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 16 Mar 2018.