HealthyNCT01168076
Noninvasive Transcutaneous Glucometer Development
An observational study of Healthy and Prediabetic State (IGT), run by InLight Solutions at 1 site in United States.
Trial summary
The objective of this study is to assist in the development of a noninvasive device for the accurate measurement of blood glucose levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Prediabetic State (IGT), Diabetes Mellitus, Type 2
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Dec 2008
- 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 with Type 1 and 2 diabetes
Who may be able to join
- 18 years of age or older
- Healthy
- Type I diabetics
- Type II diabetics
- Impaired glucose tolerance
Who cannot join
- Minor status (<18 years of age)
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to assist in the development of a noninvasive device for the accurate measurement of blood glucose levels.
Read the detailed description
The feasibility of measuring blood glucose concentration in patients with diabetes mellitus using near infrared (NIR) spectroscopy and multivariate data analysis techniques has been established using general purpose, scientific-grade infrared spectrophotometers under the 90-049 UNM HRRC protocol. Now that the concept of painless, bloodless, and reagent-less clinical laboratory tests has been shown to be viable, the challenge is to bring this technology to the patients who need it. We must develop a device that is portable, affordable, and rugged - all while improving accuracy. We must also improve our understanding of the nature of glucose in whole, intact skin. Since the light beam cannot discriminate plasma glucose in skin blood vessels from glucose in the larger skin interstitial fluid space, the exact nature of the glucose in all tissue compartments contributing to the light-beam signal must be elucidated. The noninvasive measurement can be no more accurate than the reference measurement on which it was based. Finally, we have found that the accuracy of the noninvasive measurement also worsens as a function of time from the initial measurement. This effect is independent of instrumentation drift and is due to physical changes in the patient's skin such as variation of hydration, collagen, vascularity, glycation end-products, etc. To account for these sources of physiologic interference they must be evaluated independently and then compared to errors of the noninvasive predictions over time.
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startDec 2001
- Primary completionJan 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InLight Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Rohrscheib, M.D., Principal investigator, UNMHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168076
- Sponsor's protocol ID
- ILS-01-007
- Status last verified
- Feb 2008
- First submitted
- 21 Jul 2010
- 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 Transcutaneous Glucometer Development
- ClinicalTrials.gov ID
- NCT01168076
- Acronym / sponsor ID
- ILS-01-007
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- InLight SolutionsIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Jul 2010 (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 assist in the development of a noninvasive device for the accurate measurement of blood glucose levels.
Detailed description
The feasibility of measuring blood glucose concentration in patients with diabetes mellitus using near infrared (NIR) spectroscopy and multivariate data analysis techniques has been established using general purpose, scientific-grade infrared spectrophotometers under the 90-049 UNM HRRC protocol. Now that the concept of painless, bloodless, and reagent-less clinical laboratory tests has been shown to be viable, the challenge is to bring this technology to the patients who need it. We must develop a device that is portable, affordable, and rugged - all while improving accuracy. We must also improve our understanding of the nature of glucose in whole, intact skin. Since the light beam cannot discriminate plasma glucose in skin blood vessels from glucose in the larger skin interstitial fluid space, the exact nature of the glucose in all tissue compartments contributing to the light-beam signal must be elucidated. The noninvasive measurement can be no more accurate than the reference measurement on which it was based. Finally, we have found that the accuracy of the noninvasive measurement also worsens as a function of time from the initial measurement. This effect is independent of instrumentation drift and is due to physical changes in the patient's skin such as variation of hydration, collagen, vascularity, glycation end-products, etc. To account for these sources of physiologic interference they must be evaluated independently and then compared to errors of the noninvasive predictions over time.
Study design
- Observational model
- Case only
- 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 with Type 1 and 2 diabetes
Key inclusion criteria (5 listed)
- 18 years of age or older
- Healthy
- Type I diabetics
- Type II diabetics
- Impaired glucose tolerance
Key exclusion criteria (2 listed)
- Minor status (<18 years of age)
- Pregnant
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
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 Healthy and Prediabetic State (IGT), run by InLight Solutions at 1 site 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 5 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 1 site 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.