A Clinical Study of the C8 MediSensors Optical Glucose Monitor™

Diabetes Mellitus Clinical Trial

— Spectrum  

Official title:

A Clinical Study to Evaluate the Performance of the C8 MediSensors Optical Glucose Monitor™ During On-Site Testing and Real Time Use Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726114
• Other study ID #: C8CSP_19042012
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: March 23, 2013
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: C8 MediSensors, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare glucose measurements from the C8 MediSensors non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow Springs Instrument(YSI) blood glucose analyzer.

Description:

This is a prospective, non-randomized, open label study to evaluate the performance of the C8 MediSensors non-invasive Optical Glucose Monitor™ on individuals with diabetes mellitus. Capillary blood samples will be obtained throughout a daily study session; the study session may last for up to 12 hours. Blood glucose will be measured on a YSI blood glucose analyzer. Subjects may adjust food intake and insulin administration so device performance is evaluated across a broad range of glucose concentrations. Glucose measurements will be time matched and paired for comparison. Skin effects and adverse events will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older.

2. Understands and agrees to comply with study instructions.

3. Read, understood, signed and dated the Informed Consent Form.

Exclusion Criteria:

1. Pregnancy.

2. Extensive skin changes or diseases that preclude wearing the test device at the proposed wear site(s) (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).

3. Employed by a company within the diabetes field other than the study sponsor.

4. Medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Non-invasive Optical Glucose Monitor™
Test device
• YSI blood glucose analyzer
Reference device

Locations

Country	Name	City	State
United States	C8 MediSensors, Inc.	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
C8 MediSensors, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of the test device in comparison to the reference device	The primary objective is to characterize the accuracy of the non-invasive glucose measurements from the Optical Glucose Monitor™ to blood glucose measurements on a sample size of approximately 30 subjects with 1000 time matched, paired data points.	6 months	No