Type 2 Diabetes MellitusNCT01820871
Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)
A study testing Self-Management Using Smartphone Application for Type2 DM and self-management using booklet for management type 2 DM in people with Type 2 Diabetes Mellitus, run by Inje University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (DM). Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Self-Management Using Smartphone Application for Type2 DM and self-management using booklet for management type 2 DM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Oct 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 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 DM using oral hypoglycemic agent
- 6.5% < HbA1c < 10%
- systolic blood pressure > 130 mmHg or diastolic blood pressure > 80 mmHg
- BMI over 23.0
- 20 < age < 70
- smartphone user (android OS based)
Who cannot join
- Serum fasting glucose > 250 mg/L or post prandial 2 hour serum glucose > 350 mg/L
- systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
- Diabetes mellitus patient using insulin
- severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria)
- congestive heart failure (NYHA III-IV or left ventricular ejection fraction < 30%)
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) over 3 times of upper normal limit
Show all 14Show fewer
- Serum creatinine > 1.5 mg/dL
- refusal to participate in the study
- drug addiction or alcohol addiction
- major psychiatric illness
- steroid treatment or hormonal treatment with changing the drug or drug dosage in 1 month
- changing dosage of antihypertensive agent, oral hypoglycemic agent or lipid lowering agent in 1 month
- malignant cancer
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Self Management Using Application for Chronic Disease Care in Real siTuation (SMART) - DM
The purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (DM).
Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. However, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 DM.
Thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Self-Management Using Smartphone Application for Type2 DM, self-management using booklet for management type 2 DM
- Keywords
- T2DM, smartphone application, serum fasting glucose, HbA1c
- 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.
Self-Management Using Smartphone Application for Type2 DMOther
self-management using booklet for management type 2 DMOther
| Study group | Role | What they receive |
|---|---|---|
| application arm | Experimental | The patients of application arm have the smartphone application (android) for management of type 2 DM.
The application contains action plans and alarm system for each situation of serum fasting glucose, blood pressure, body weight, exercise amount, calori intake, medication, etc. Receives: Other: Self-Management Using Smartphone Application for Type2 DM |
| conventional arm | Active comparator | The patients of conventional arm have the booklet for management of type 2 DM. The application contains general medical guideline and knowledge for management of type 2 DM such as,exercise amount, calori intake, medication, etc. Receives: Other: self-management using booklet for management type 2 DM |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting serum glucose and HbA1c
we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90)
Measured: 3months after enrollemnt (day 0-day 90)
Secondary outcomes (2)
body weight and BMI
we will check body weight and BMI at the day of enrollment (day0)and those at 3months after enrollment (day 90)
Measured: 3months after enrollemnt (day 0-day 90)
Lipid profile
we will check the lipid profile (total cholesterol, Triglyceride, LDL/HDL cholesterol)at the day of enrollment (day0)and those at 3months after enrollment (day 90)
Measured: 3months after enrollment (day 0-90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionOct 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jongha Park, Inje University
- Investigators
- Jongha Park, MD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820871
- Sponsor's protocol ID
- SMART-DM
- Status last verified
- Nov 2013
- First submitted
- 26 Mar 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Self Management Using Application for Chronic Disease Care in Real siTuation (SMART) - DM
- ClinicalTrials.gov ID
- NCT01820871
- Acronym / sponsor ID
- SMART-DM
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- T2DM, smartphone application, serum fasting glucose, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Mar 2013 (estimated)
- 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 purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (DM).
Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. However, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 DM.
Thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| application arm | Experimental | Other: Self-Management Using Smartphone Application for Type2 DMThe patients of application arm have the smartphone application (android) for management of type 2 DM. The application contains action plans and alarm system for each situation of serum fasting glucose, blood pressure, body weight, exercise amount, calori intake, medication, etc. |
| conventional arm | Active comparator | Other: self-management using booklet for management type 2 DMThe patients of conventional arm have the booklet for management of type 2 DM. The application contains general medical guideline and knowledge for management of type 2 DM such as,exercise amount, calori intake, medication, etc. |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 DM using oral hypoglycemic agent
- 6.5% < HbA1c < 10%
- systolic blood pressure > 130 mmHg or diastolic blood pressure > 80 mmHg
- BMI over 23.0
- 20 < age < 70
Key exclusion criteria (14 listed)
- Serum fasting glucose > 250 mg/L or post prandial 2 hour serum glucose > 350 mg/L
- systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
- Diabetes mellitus patient using insulin
- severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria)
- congestive heart failure (NYHA III-IV or left ventricular ejection fraction < 30%)
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 |
|---|---|---|
| Self-Management Using Smartphone Application for Type2 DM | Other | application arm |
| self-management using booklet for management type 2 DM | Other | conventional arm |
Primary outcome
fasting serum glucose and HbA1c
Time frame: 3months after enrollemnt (day 0-day 90)
we will check the fasting serum glucose and HbA1C at the day of enrollment (day0)and those at 3months after enrollment (day 90)
2 secondary outcomes
body weight and BMI
Time frame: 3months after enrollemnt (day 0-day 90)
Lipid profile
Time frame: 3months after enrollment (day 0-90)
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 27 Nov 2013.
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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.
Jongha Park, MD principal investigator
Inje University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Using Smartphone Application for Type2 DM and self-management using booklet for management type 2 DM in people with Type 2 Diabetes Mellitus, run by Inje University at 1 site in South Korea.
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 14 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 27 Nov 2013. 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 South Korea. 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?
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?
fasting serum glucose and HbA1c (time frame: 3months after enrollemnt (day 0-day 90)). 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 27 Nov 2013; AzTrials last refreshed its copy on 2 Nov 2026.