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Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01415544
Recruitment Status : Unknown
Verified February 2012 by InLight Solutions.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2011
Last Update Posted : February 27, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to prospectively evaluate a noninvasive, near-infrared based method for measuring glucose concentration relative to invasive blood reference measurements. The initial phase of the study will be focused on procurement of the data needed to develop a robust, accurate calibration. The second phase will be focused on performance evaluation of the system.

Condition or disease
Type 1 Diabetes Type 2 Diabetes Gestational Diabetes

Detailed Description:

Currently, individuals with diabetes must use an invasive finger stick methodology for the determination of their blood glucose levels. Although current technology glucose meters use a smaller amount of blood than older generation meters, the pain and inconvenience associated with this invasive measurement is the number one reason cited for inadequate or infrequent blood glucose monitoring. In fact up to 67% of patients with diabetes fail to routinely monitor their blood glucose levels. A survey of 1895 patients showed that finger soreness was the most common reason given for self-reported noncompliance with testing recommendations, followed by pain, inconvenience, fear of needles, and "other" (including cost), (Diabetes Care August 2001 vol. 24 no. 8 1502-1503). The ability to make a painless blood glucose measurement using only light would address the pain and inconvenience issues associated with current technology glucose meters.

The initial application of the technology is associated with the monitoring of Gestational Diabetes. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) recently released recommendations for diagnosing gestational diabetes, as well as clarifying the benefits of treatment (Diabetes Care, 2010;33:676-682). The IADPSG cited research that found significant graded relationships between increasing maternal glucose levels and the frequency of four primary and five secondary outcomes. For example, with a 1-standard deviation increase in maternal fasting, 1-hour, and 2-hour plasma glucose levels, there was a corresponding 38%, 46%, and 38% increased risk, respectively, in the primary outcome of birth weight >90th percentile, and a 5%, 18%, and 16% increased risk, respectively, of the secondary outcome of premature delivery before 37 weeks gestation (N Engl J Med 2008;358:1991-2002).


Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
Study Start Date : June 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Type 2 Diabetes
Those previously diagnosed with type 2 diabetes
Type 1 Diabetes
Those previously diagnosed with type 1 diabetes
Gestational Diabetes
Those that are currently diagnosed with gestational diabetes
Healthy Human Volunteers
Those that have not been diagnosed with any type of diabetes


Outcome Measures

Primary Outcome Measures :
  1. Calibrate near-infrared spectroscopy-based glucose meter [ Time Frame: 1 year ]
    The collection of capillary blood glucose and noninvasive data will allow the calibration of the noninvasive systems and subsequently evaluate performance via a validation study. The paired NIR spectrum and blood reference data acquired during calibration will be processed using multivariate regression techniques to create a calibration model. Results will be compared using a Clark error grid.


Secondary Outcome Measures :
  1. Compare Noninvasive to invasive techniques [ Time Frame: 1 year ]
    Comparison of noninvasive glucose measurement performance versus standard invasive reference. Invasive measurements are made by obtaining capillary blood glucose measurements and then measuring blood on a Yellow Springs Instrument (YSI). Due to the fact that instrumentation drift and subject physiological changes can adversely influence measurement performance, the study is specifically designed to examine performance over an appropriate period of time with a reasonable distribution of subject variance. Results will be compared using a Clark error grid.


Biospecimen Retention:   None Retained
capillary glucose measurements

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The Human Subject population consists of female subjects between the ages of 20 and 50. Subjects must have been diagnosed with either Type I, Type II, or Gestational diabetes and may utilize healthy individuals for the validation phase. Up to 100 subjects may be recruited to participate in this study. Subjects will be recruited from the community and will be selected to ensure a representative sample of the projected intended use population. Efforts will also be made to ensure a broad and even distribution of ages (between 20 and 50 years old) and ethnicities.
Criteria

Inclusion Criteria:

  • Female at least 20 years of age but not older than 50 years of age
  • Female with Type I or Gestational diabetes based on ADA criteria
  • Female with Type II diabetes and A1c of greater than 7.0 as measured on a Bayer A1C Now meter
  • May include female healthy volunteers.

Exclusion Criteria:

  • Subject requires hemo-dialysis
  • Severe heart disease as evidenced by peripheral edema
  • Liver disease as evidenced by jaundice
  • Active alcohol or drug abuse
  • Body Mass Index (BMI) > 35 kg/m2
  • Hand size too large to fit in the optical measurement instrumentation
  • Middle finger width of less than 5 mm
  • Skin damage at optical sampling site on hand
  • Currently taking prednisone or other systemic steroids
  • Tattoo at the optical sampling site
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415544


Locations
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
InLight Solutions
Investigators
Principal Investigator: Walter Forman, MD Lovelace Scientific Resources
More Information

Responsible Party: InLight Solutions
ClinicalTrials.gov Identifier: NCT01415544     History of Changes
Other Study ID Numbers: 10-0020
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012

Keywords provided by InLight Solutions:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pregnancy Complications