Type 2 DiabetesNCT01041144
Effects of Health Care Provider-mediated, Remote Coaching System Through the PDA-type Glucometer and the Internet on Diabetes Management
A study testing lifestyle counseling in people with Type 2 Diabetes and Lifestyle Intervention, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effectiveness of the new diabetes care delivery system applied to preexisting public health care resources through advanced information technologies such as PDA-type glucometer and the Internet on the glycemic control of type 2 diabetes patients lived in isolated rural… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Type 2 Diabetes, Lifestyle Intervention, Glucose Control
- What is being tested?
- lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- 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 40 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients
- Aged ≥ 40 years
- Baseline HbA1c of 7.0 to 11.0 % who had been already followed up for more than 6 months in the health care post
Who cannot join
- Participants with diagnosed or suspected disease of the liver, pancreas, endocrine organs, or kidney
- Ischemic heart disease or cerebrovascular disease or a history of such disease
- A creatinine level > 0.133 mmol/L
- Treatment with an intensified insulin regimens and those unable .
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effectiveness of the new diabetes care delivery system applied to preexisting public health care resources through advanced information technologies such as PDA-type glucometer and the Internet on the glycemic control of type 2 diabetes patients lived in isolated rural area.
The investigators conducted a prospective, randomized, controlled trial in patients with type 2 diabetes for 12 weeks. The intervention group was treated with the new health care delivery system, where diabetes center provided specialized management, mediated by nurse of primary health care posts using the Internet and the PDA-type glucometer, while the control group with conventional health care. HbA1c, fasting plasma glucose and lipids levels were measured at baseline and follow-up.
- Being tested
- lifestyle counseling
- Keywords
- Diabetes, PDA, Internet, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle counselingBehavioural
supporting diabetes patients using Internet communication
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Secondary outcomes (1)
PP2hr Lipid profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Supportive care
- Enrolment
- 115 participants
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry for Health Welfare and Family Affairs
- Investigators
- Kun-Ho Yoon, Ph.D., Principal investigator, Catholic Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041144
- Sponsor's protocol ID
- Seoul R&D Project
- Status last verified
- Jun 2005
- First submitted
- 30 Dec 2009
- Last updated
- 31 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Health Care Provider-mediated, Remote Coaching System Through the PDA-type Glucometer and the Internet on Diabetes Management
- ClinicalTrials.gov ID
- NCT01041144
- Acronym / sponsor ID
- Seoul R&D Project
- Keywords
- Diabetes, PDA, Internet, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Ministry for Health Welfare and Family Affairs
- First posted
- 31 Dec 2009 (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 investigate the effectiveness of the new diabetes care delivery system applied to preexisting public health care resources through advanced information technologies such as PDA-type glucometer and the Internet on the glycemic control of type 2 diabetes patients lived in isolated rural area.
The investigators conducted a prospective, randomized, controlled trial in patients with type 2 diabetes for 12 weeks. The intervention group was treated with the new health care delivery system, where diabetes center provided specialized management, mediated by nurse of primary health care posts using the Internet and the PDA-type glucometer, while the control group with conventional health care. HbA1c, fasting plasma glucose and lipids levels were measured at baseline and follow-up.
Study design
- Primary purpose
- Supportive care
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: lifestyle counseling |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes patients
- Aged ≥ 40 years
- Baseline HbA1c of 7.0 to 11.0 % who had been already followed up for more than 6 months in the health care post
Key exclusion criteria (4 listed)
- Participants with diagnosed or suspected disease of the liver, pancreas, endocrine organs, or kidney
- Ischemic heart disease or cerebrovascular disease or a history of such disease
- A creatinine level > 0.133 mmol/L
- Treatment with an intensified insulin regimens and those unable .
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 |
|---|---|---|
| lifestyle counselingsupporting diabetes patients using Internet communication | Behavioural | Lifestyle counseling |
Primary outcome
HbA1c
1 secondary outcome
PP2hr Lipid profile
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 31 Dec 2009.
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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.
Kun-Ho Yoon, Ph.D. principal investigator
Catholic Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle counseling in people with Type 2 Diabetes and Lifestyle Intervention, run by The Catholic University of Korea 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 3 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: finished, as of the sponsor's last update on 31 Dec 2009. 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. 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 31 Dec 2009.