Diabetes MellitusSMARTCARE_DMNCT01505036
Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
A study testing SMARTCARE service in people with Diabetes Mellitus, run by SK Telecom Consortium at 1 site in South Korea.
Trial summary
SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- SMARTCARE service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Sep 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetes
- At least 1 year after being diagnosed with Type 2 diabetes
- 7.0% ≤ HbA1c ≤ 10.0%
- Agreed to participate voluntarily in the study
Who cannot join
- Severe chronic disease
- Diabetes mellitus complications
- Severe renal disease; Serum creatinin > 1.5(men), > 1.4 (women)
- Severe liver disease or AST, ALT ≥ 2.5 x ULN
- Known not to be taking medication reliably 3 months before the screening visit
- Insulin pump user
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- Being registered for other clinical research or are planning to participate in other clinical researches during this study
- Pregnant woman
- Illiterate
- Being assessed irrelevant by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Multi-center, Open-label, Parallel Group Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes.
Read the detailed description
Primary Outcome Measure: To see if there's any change in HbA1C at Visit 6 (12M) compared Visit 2 (baseline) within each group and between the two groups.
All statistical analysis will progress through the SAS (Version 9.1). statistical test's significance level is 0.05. The principle is two-sided test.
Secondary Outcome Measures :
To see if there's any change in HbA1C at each Visit (Visit 3 - Visit 6) compared Visit 2 (baseline) within each group and between the two groups.
Add a Secondary Outcome Measure:
Treatment satisfaction (DTSQ, Diabetes Treatment Satisfaction Questionnaire): To see if there's any change in treatment satisfaction scores compared Visit 2 (baseline) within each group and between the two groups.
- Conditions
- Diabetes Mellitus
- Being tested
- SMARTCARE service
- Keywords
- Diabetes Mellitus, smart-care, U-health care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTCARE serviceOther
Also called U-Healthcare
U-Healthcare service
| Study group | Role | What they receive |
|---|---|---|
| SMARTCARE service | Experimental | U-Health service Receives: Other: SMARTCARE service |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who attain,Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
Rate of patients who attain, Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
Measured: 0 to 12 months
Secondary outcomes (7)
Change in Hemoglobin A1C at visit 3,4,6 from baseline
Change in Hemoglobin A1C at Visit3,4,6 from baseline. Reduce Hemoglobin A1c after study
Measured: 0 to 12 months
change in QOL(Quality of life)
Change in QOL(Quality of life) at Visit 6 from baseline.
Measured: 0 to 12 months
Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire)
change in Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire) at Visit 6 from baseline.
Measured: 0 to 12 months
Changes in lipid profile at Visit 4 and 6 from baseline.
Changes in lipid profile at visit 4 and 6 from baseline. Reduction of lipid profile
Measured: 0 to 12 months
Changes in body weight
Changes in body weight at each visit(visit 3,4,5,6) from baseline during 12 months. Reduction of body weight
Measured: 0 to 12 months
Changes in Waist Circumference(WC)
Changes in Waist Circumference(WC) at each visit(visit 3,4,5,6) from baseline during 12 months.
Reduction of Waist Circumference(WC)
Measured: 0 to 12 months
Changes in Blood Pressure
Changes in Blood Pressure at each visit(visit 3,4,5,6) from baseline during 12 months.
Changes in mean Blood Pressure
Measured: 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startDec 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Telecom Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kun-ho YOON, professor, Principal investigator, Seoul St. Mary's Hospitalsung-woo PARK, Professor, Principal investigator, Kanbuk Samsung Medical CenterJung-yeol PARK, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505036
- Sponsor's protocol ID
- SMARTCARE_DM
- Acronym
- SMARTCARE_DM
- Status last verified
- Feb 2013
- First submitted
- 19 Jul 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multi-center, Open-label, Parallel Group Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
- ClinicalTrials.gov ID
- NCT01505036
- Acronym / sponsor ID
- SMARTCARE_DM / SMARTCARE_DM
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, smart-care, U-health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- SK Telecom ConsortiumUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Jan 2012 (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.
SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes.
Detailed description
Primary Outcome Measure: To see if there's any change in HbA1C at Visit 6 (12M) compared Visit 2 (baseline) within each group and between the two groups.
All statistical analysis will progress through the SAS (Version 9.1). statistical test's significance level is 0.05. The principle is two-sided test.
Secondary Outcome Measures :
To see if there's any change in HbA1C at each Visit (Visit 3 - Visit 6) compared Visit 2 (baseline) within each group and between the two groups.
Add a Secondary Outcome Measure:
Treatment satisfaction (DTSQ, Diabetes Treatment Satisfaction Questionnaire): To see if there's any change in treatment satisfaction scores compared Visit 2 (baseline) within each group and between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMARTCARE service | Experimental | Other: SMARTCARE serviceU-Health service |
| Usual care | No intervention | –Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- At least 1 year after being diagnosed with Type 2 diabetes
- 7.0% ≤ HbA1c ≤ 10.0%
- Agreed to participate voluntarily in the study
Key exclusion criteria (10 listed)
- Severe chronic disease
- Diabetes mellitus complications
- Severe renal disease; Serum creatinin > 1.5(men), > 1.4 (women)
- Severe liver disease or AST, ALT ≥ 2.5 x ULN
- Known not to be taking medication reliably 3 months before the screening visit
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 |
|---|---|---|
| SMARTCARE serviceAlso: U-HealthcareU-Healthcare service | Other | SMARTCARE service |
Primary outcome
Rate of patients who attain,Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
Time frame: 0 to 12 months
Rate of patients who attain, Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
7 secondary outcomes
Change in Hemoglobin A1C at visit 3,4,6 from baseline
Time frame: 0 to 12 months
change in QOL(Quality of life)
Time frame: 0 to 12 months
Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire)
Time frame: 0 to 12 months
Changes in lipid profile at Visit 4 and 6 from baseline.
Time frame: 0 to 12 months
Changes in body weight
Time frame: 0 to 12 months
Changes in Waist Circumference(WC)
Time frame: 0 to 12 months
Changes in Blood Pressure
Time frame: 0 to 12 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 6 Feb 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.
kun-ho YOON, professor principal investigator
Seoul St. Mary's Hospital
sung-woo PARK, Professor principal investigator
Kanbuk Samsung Medical Center
Jung-yeol PARK, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMARTCARE service in people with Diabetes Mellitus, run by SK Telecom Consortium 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 4 inclusion and 10 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 6 Feb 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?
Rate of patients who attain,Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months. (time frame: 0 to 12 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 6 Feb 2013.