Insulin Dependent DiabetesNCT01745900
Evaluation and Comparison of Noninvasive Blood Glucose Concentrations
An observational study of Insulin Dependent Diabetes and Non Insulin Dependent Diabetes, run by VeraLight, Inc. at 1 site in United States.
Trial summary
Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Dependent Diabetes, Non Insulin Dependent Diabetes, Gestational Diabetes
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Mar 2013
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females 18-50 years of age selected from the community 30% with no history of Diabetes 70% with diagnosis of Type I, Type II or Gestational Diabetes
Who may be able to join
- Female aged ≥ 18 and ≤ 50 years of age at time of enrollment
- Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes.
Who cannot join
- Severe heart disease as evidenced by peripheral edema (self reported)
- Currently taking Lasix (self reported)
- Liver disease as evidenced by jaundice (self reported)
- Receiving dialysis or having known renal compromise (self reported)
- Skin damage at optical sampling site
- Scars, tattoos, rashes or other disruption/discoloration on the right index finger
- Recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported)
- Current chemotherapy, or chemotherapy within the past 12 months (self reported)
Trial locations and contacts
1 site in 1 country.
Amber Brassfield, RN contact
Amber Brassfield, RN contact
United States1 site, 1 recruiting
- Recruiting
Accelovance Inc.
San Diego, California, 92108
Amber Brassfield, RN
About this study
Official title: An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.
Read the detailed description
The objectives of this study are
- collect subject data on a near-infrared spectroscopy-based glucose meter
- evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques
- collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.
- Keywords
- Diabetes, Gestational Diabetes, Female
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Gestational, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuing validation of near infrared spectroscopy-based glucose meter algorithm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Dependent 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
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InLight Solutions
- Responsible party
- Sponsor
- Investigators
- Amber Brassfield, RN, Principal investigator, Accelovance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745900
- Sponsor's protocol ID
- VL-240
- Status last verified
- Dec 2012
- First submitted
- 4 Dec 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
- ClinicalTrials.gov ID
- NCT01745900
- Acronym / sponsor ID
- VL-240
- Keywords
- Diabetes, Gestational Diabetes, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Collaborators
- InLight Solutions
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 10 Dec 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.
Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.
Detailed description
The objectives of this study are
- collect subject data on a near-infrared spectroscopy-based glucose meter
- evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques
- collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females 18-50 years of age selected from the community 30% with no history of Diabetes 70% with diagnosis of Type I, Type II or Gestational Diabetes
Key inclusion criteria (2 listed)
- Female aged ≥ 18 and ≤ 50 years of age at time of enrollment
- Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes.
Key exclusion criteria (8 listed)
- Severe heart disease as evidenced by peripheral edema (self reported)
- Currently taking Lasix (self reported)
- Liver disease as evidenced by jaundice (self reported)
- Receiving dialysis or having known renal compromise (self reported)
- Skin damage at optical sampling site
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
Continuing validation of near infrared spectroscopy-based glucose meter algorithm
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
Related trials for Insulin Dependent Diabetes
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
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.
Amber Brassfield, RN contact
Amber Brassfield, RN contact
Amber Brassfield, RN principal investigator
Accelovance
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 Insulin Dependent Diabetes and Non Insulin Dependent Diabetes, run by VeraLight, Inc. 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amber Brassfield, RN (619-291-2845), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuing validation of near infrared spectroscopy-based glucose meter algorithm (time frame: 3 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 10 Dec 2012.