Prediabetic StateNCT00358254
Noninvasive Skin Spectroscopy for Diabetes Screening
An observational study of Prediabetic State and Diabetes Mellitus, Type 2, run by InLight Solutions at 2 sites in United States.
Trial summary
The objective of this study is to assess the performance of a noninvasive device for the early screening of Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State, Diabetes Mellitus, Type 2
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2004to Dec 2007
- 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: Those at risk for diabetes
Who may be able to join
- Volunteers without Diabetes.
- Volunteers at risk for developing Type II diabetes.
- 18 years of age and older.
Who cannot join
- Under 18 years of age.
- Those diagnosed with Diabetes.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
InLight Solutions
Albuquerque, New Mexico, 87106
Tricore Reference Laboratory- Presbyterian Professional Building
Albuquerque, New Mexico, 87106
About this study
The objective of this study is to assess the performance of a noninvasive device for the early screening of Diabetes Mellitus.
Read the detailed description
Approximately 18 million people have Type II diabetes, and of these, an estimated thirty-five percent are unaware of their condition. This translates to roughly 6.3 million undiagnosed cases worldwide in 2002. Many diagnoses are made years after the onset of the disease. This allows progression of the vascular lesions that arise during the time of uncontrolled glucose levels. As a result, microvascular retinopathy, nephropathy, and neuropathy are on the rise, as well as macrovascular complications such as: coronary heart disease, and cerebral vascular accidents. The prevalence and trends of diabetes underscore the need for effective and widespread screening. Our fluorescence based system under development will noninvasively measure skin glycation end products that are known to be strongly correlated with diabetes status and complications. Since the test would be painless and require no patient fasting, significant obstacles to screening compliance would be mitigated. The system offers hope for a screening test that is more sensitive and specific than the invasive tests currently used for diabetes screening (Oral Glucose Tolerance Test (OGTT) and the Fasting Plasma Glucose (FPG) test).
- Conditions
- Prediabetic State, Diabetes Mellitus, Type 2
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study startOct 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InLight Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VeraLight, Inc.
- Investigators
- Mark Rohrscheib, M.D., Principal investigator, UNMHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358254
- Sponsor's protocol ID
- ILS-04-262
- Status last verified
- Nov 2007
- First submitted
- 27 Jul 2006
- Last updated
- 22 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Skin Spectroscopy for Diabetes Screening
- ClinicalTrials.gov ID
- NCT00358254
- Acronym / sponsor ID
- ILS-04-262
- Conditions
- Prediabetic State, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- InLight SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- VeraLight, Inc.
- Study start
- Oct 2004
- Study completion
- Dec 2007 (actual)
- First posted
- 31 Jul 2006 (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 objective of this study is to assess the performance of a noninvasive device for the early screening of Diabetes Mellitus.
Detailed description
Approximately 18 million people have Type II diabetes, and of these, an estimated thirty-five percent are unaware of their condition. This translates to roughly 6.3 million undiagnosed cases worldwide in 2002. Many diagnoses are made years after the onset of the disease. This allows progression of the vascular lesions that arise during the time of uncontrolled glucose levels. As a result, microvascular retinopathy, nephropathy, and neuropathy are on the rise, as well as macrovascular complications such as: coronary heart disease, and cerebral vascular accidents. The prevalence and trends of diabetes underscore the need for effective and widespread screening. Our fluorescence based system under development will noninvasively measure skin glycation end products that are known to be strongly correlated with diabetes status and complications. Since the test would be painless and require no patient fasting, significant obstacles to screening compliance would be mitigated. The system offers hope for a screening test that is more sensitive and specific than the invasive tests currently used for diabetes screening (Oral Glucose Tolerance Test (OGTT) and the Fasting Plasma Glucose (FPG) test).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those at risk for diabetes
Key inclusion criteria (3 listed)
- Volunteers without Diabetes.
- Volunteers at risk for developing Type II diabetes.
- 18 years of age and older.
Key exclusion criteria (2 listed)
- Under 18 years of age.
- Those diagnosed with Diabetes.
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
Not reported in the source record.
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 22 Jul 2010.
- Related InfoLink provided by the sponsor.
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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.
Mark Rohrscheib, M.D. principal investigator
UNMHSC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetic State and Diabetes Mellitus, Type 2, run by InLight Solutions at 2 sites in United States.
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 2 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 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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 22 Jul 2010.