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

InLight Solutions

Status

Unknown

Conditions

Gestational Diabetes

Type 1 Diabetes

Type 2 Diabetes

Study type

Observational

Funder types

Industry

Identifiers

NCT01415544

10-0020

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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