DiabetesNCT00489879
Management of Patients With Type 2 Diabetes and Hypertension Using Mobile Health Care System
A study testing Mobile Health Care System (DrUB) in people with Diabetes and Hypertension, run by Korea University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether cellular phone based health care system is effective in the treatment of diabetes and hypertension. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes, Hypertension, Obesity
- What is being tested?
- Mobile Health Care System (DrUB)
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to Oct 2007
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type II diabetes using only oral hypoglycemic agents
- 7% < HbA1c < 10%
- systolic blood pressure > 130 or diastolic blood pressure > 80
- BMI > 23
- 20 < age < 75
Who cannot join
- type I diabetes or type II diabtes using insulin treatment
- liver, renal or heart disease
- recent change (within 1 month) in the type or dosage of anti-diabetic agent, anti-hypertensive medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Korea University College of Medicine
Seoul, VD, 152-703
About this study
Official title: Efficacy of Mobile Health Care System in Patients With Type 2 Diabets and Hypertension
The purpose of this study is to determine whether cellular phone based health care system is effective in the treatment of diabetes and hypertension.
Read the detailed description
Diabetes care is facilitated by a patient's being engaged in a self-management program with the advice and counsel of physicians, but many diabetic patients can not receive the continous monitoing and advice from his physician in their every day life. It is very difficult to keep up life style modification in their real life.
Few studies have examined the effects of cellular phone based intervention that provide an interactive component daily. Our goal is to test the hypothesis that diabetes and hypertension management using cellular phone based health care system would result in significant improvement of blood glucose and blood pressure level.
- Conditions
- Diabetes, Hypertension, Obesity
- Being tested
- Mobile Health Care System (DrUB)
- Keywords
- Mobile Health Units, Chronic Disease
- Medical subject headings
- Diabetes Mellitus, Hypertension, Obesity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Care System (DrUB)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles
Measured: baseline, 3months later
Secondary outcomes (1)
exercise time during one week, self reported change in dietary habit, fat consumption ratio
Measured: baseline, 3months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2007
- Study completionOct 2007
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 DiabetesStudies 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
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Investigators
- Kyung M Choi, MD, Principal investigator, Department of Internal Medicine, Korea University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489879
- Sponsor's protocol ID
- Seoul R&BD Program
- Status last verified
- May 2008
- First submitted
- 20 Jun 2007
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. doi: 10.2337/diacare.27.2.478.
PubMed 14747232
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mobile Health Care System in Patients With Type 2 Diabets and Hypertension
- ClinicalTrials.gov ID
- NCT00489879
- Acronym / sponsor ID
- Seoul R&BD Program
- Conditions
- Diabetes, Hypertension, Obesity
- Keywords
- Mobile Health Units, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 21 Jun 2007 (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 determine whether cellular phone based health care system is effective in the treatment of diabetes and hypertension.
Detailed description
Diabetes care is facilitated by a patient's being engaged in a self-management program with the advice and counsel of physicians, but many diabetic patients can not receive the continous monitoing and advice from his physician in their every day life. It is very difficult to keep up life style modification in their real life.
Few studies have examined the effects of cellular phone based intervention that provide an interactive component daily. Our goal is to test the hypothesis that diabetes and hypertension management using cellular phone based health care system would result in significant improvement of blood glucose and blood pressure level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- type II diabetes using only oral hypoglycemic agents
- 7% < HbA1c < 10%
- systolic blood pressure > 130 or diastolic blood pressure > 80
- BMI > 23
- 20 < age < 75
Key exclusion criteria (3 listed)
- type I diabetes or type II diabtes using insulin treatment
- liver, renal or heart disease
- recent change (within 1 month) in the type or dosage of anti-diabetic agent, anti-hypertensive medication
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 Health Care System (DrUB) | Device | – |
Primary outcome
HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles
Time frame: baseline, 3months later
1 secondary outcome
exercise time during one week, self reported change in dietary habit, fat consumption ratio
Time frame: baseline, 3months later
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 20 May 2008.
- Background: PubMed 14747232Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. doi: 10.2337/diacare.27.2.478.
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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.
Kyung M Choi, MD principal investigator
Department of Internal Medicine, Korea University College of Medicine
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 Health Care System (DrUB) in people with Diabetes and Hypertension, run by Korea 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 5 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 20 May 2008. 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?
HbA1c, fasting blood glucose level, Weight change, Blood pressure level in the morning, lipid profiles (time frame: baseline, 3months later). 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 NCT00489879, 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 20 May 2008.