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

• Conditions: Type 2 Diabetes; Gestational Diabetes; Type 1 Diabetes

• Registration Number: NCT01415544
• Lead Sponsor: InLight Solutions

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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-12
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-23
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calibrate near-infrared spectroscopy-based glucose meter	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

Name	Time	Method
Compare Noninvasive to invasive techniques	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.

Trial Locations

Locations (1)

Lovelace Scientific Resources; 🇺🇸 Albuquerque, New Mexico, United States