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

NCT ID: NCT01415544

Last Updated: 2012-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-02-29

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).

Conditions

Type 1 Diabetes; Type 2 Diabetes; Gestational Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Type 2 Diabetes

Those previously diagnosed with type 2 diabetes

No interventions assigned to this group

Type 1 Diabetes

Those previously diagnosed with type 1 diabetes

No interventions assigned to this group

Gestational Diabetes

Those that are currently diagnosed with gestational diabetes

No interventions assigned to this group

Healthy Human Volunteers

Those that have not been diagnosed with any type of diabetes

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

InLight Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Forman, MD

Role: PRINCIPAL_INVESTIGATOR

Lovelace Scientific Resources

Locations

Lovelace Scientific Resources

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

10-0020

Identifier Type: -

Identifier Source: org_study_id