Type 2 DiabetesNCT01572415
Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus
An observational study of Type 2 Diabetes, run by VeraLight, Inc. at 1 site in Greece.
Trial summary
The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 409 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2011to Mar 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects must be 18 years of age or greater.
Who may be able to join
- Age greater than or equal to 45 years
- OR
- Age 18 to 44 years and with one or more of the following risk factors:
- BMI > 25 kg/m²
- Elevated waist circumference, > 35 inches for women and >40 inches for men
- Habitually physically inactive (does not exercise regularly)
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- Has a first-degree relative with diabetes
- Ethnicity with elevated risk for type 2 diabetes
- Has delivered a baby weighing > 9 lb or diagnosed with gestational diabetes
- Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension
- HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
- Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
- Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 yrs
- Conditions associated with insulin resistance such as acanthosis nigricans
- History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease
Who cannot join
- • Under 18 years of age
- Receiving investigational treatments in the past 14 days
- Psychosocial issues that interfere with an ability to follow study procedures
- Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
- Diagnosed with any type of diabetes, including type 1 or 2
- Taking glucose lowering medications with the exception of metformin
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- Known to be pregnant
- Receiving dialysis or having known renal compromise
- Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
- Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded
- Current chemotherapy, or chemotherapy within the past 12 months
- Receiving medications that fluoresce*
- Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%.
Read the detailed description
The study will complete up to 400 subjects at the clinical site to evaluate the precision and accuracy of SCOUT DS and random capillary glucose for detecting pre-diabetes and undiagnosed type 2 diabetes in subjects at risk but not having a pre-existing diagnosis of type 2 diabetes. A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤ 6.4%) and diabetes (A1c ≥ 6.5%).
The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months.
The target cohort for comprises persons at risk for pre-diabetes and/or type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Keywords
- Screening for Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of SCOUT DS to Random Capillary Glucose
A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤ 6.4%) and diabetes (A1c ≥ 6.5%).
The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months.
The target cohort for comprises persons at risk for pre-diabetes and/or type 2 diabetes.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionMar 2012
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Greece National Social Insurance Institute, Laikο General Hospital, Athens
- Responsible party
- Sponsor
- Investigators
- Nicholas Tentolouris, MD, Principal investigator, LAIKO General Hospital/University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572415
- Sponsor's protocol ID
- VL-MK01
- Status last verified
- Dec 2012
- First submitted
- 3 Apr 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tentolouris N, Lathouris P, Lontou S, Tzemos K, Maynard J. Screening for HbA1c-defined prediabetes and diabetes in an at-risk greek population: performance comparison of random capillary glucose, the ADA diabetes risk test and skin fluorescence spectroscopy. Diabetes Res Clin Pract. 2013 Apr;100(1):39-45. doi: 10.1016/j.diabres.2013.01.002. Epub 2013 Jan 28.
PubMed 23369230
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01572415
- Acronym / sponsor ID
- VL-MK01
- Conditions
- Type 2 Diabetes
- Keywords
- Screening for Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Greece National Social Insurance Institute, Laikο General Hospital, Athens
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Apr 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.
The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1C ≥ 6.0%.
Detailed description
The study will complete up to 400 subjects at the clinical site to evaluate the precision and accuracy of SCOUT DS and random capillary glucose for detecting pre-diabetes and undiagnosed type 2 diabetes in subjects at risk but not having a pre-existing diagnosis of type 2 diabetes. A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤ 6.4%) and diabetes (A1c ≥ 6.5%).
The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months.
The target cohort for comprises persons at risk for pre-diabetes and/or type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must be 18 years of age or greater.
Key inclusion criteria (15 listed)
- Age greater than or equal to 45 years
- OR
- BMI > 25 kg/m²
- Elevated waist circumference, > 35 inches for women and >40 inches for men
- Habitually physically inactive (does not exercise regularly)
Key exclusion criteria (13 listed)
- • Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of SCOUT DS to Random Capillary Glucose
Time frame: Up to 6 months
A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤ 6.4%) and diabetes (A1c ≥ 6.5%). The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months. The target cohort for comprises persons at risk for pre-diabetes and/or type 2 diabetes.
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 5 Dec 2012.
- Derived from this study: PubMed 23369230Tentolouris N, Lathouris P, Lontou S, Tzemos K, Maynard J. Screening for HbA1c-defined prediabetes and diabetes in an at-risk greek population: performance comparison of random capillary glucose, the ADA diabetes risk test and skin fluorescence spectroscopy. Diabetes Res Clin Pract. 2013 Apr;100(1):39-45. doi: 10.1016/j.diabres.2013.01.002. Epub 2013 Jan 28.
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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.
Nicholas Tentolouris, MD principal investigator
LAIKO General Hospital/University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by VeraLight, Inc. at 1 site in Greece.
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 15 inclusion and 13 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 5 Dec 2012. 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 Greece. 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?
Comparison of SCOUT DS to Random Capillary Glucose (time frame: Up to 6 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 NCT01572415, 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 5 Dec 2012.