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

Type 2 Diabetes Clinical Trial

Official title:

An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01415544
• Other study ID #: 10-0020
• Status: Active, not recruiting
• Phase: N/A
• First received: August 9, 2011
• Last updated: February 23, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: InLight Solutions
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Type 1 Diabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Lovelace Scientific Resources	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
InLight Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calibrate near-infrared spectroscopy-based glucose meter	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.	1 year	No
Secondary	Compare Noninvasive to invasive techniques	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.	1 year	No