Status:
COMPLETED
Performance Evaluation of a Non-Invasive Glucose Monitor as Compared to CGM Data Acquired by the iPro2
Lead Sponsor:
Sansum Diabetes Research Institute
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-75 years
Brief Summary
This study is for adults and adolescents with type 1 diabetes. The purpose of this study is to learn more about an investigational system to measure blood glucose. This system does not require blood t...
Detailed Description
The purpose of the study is to evaluate the utility of a novel approach to non-invasive glucose sensing. The testing for each patient includes fingerstick and alternate site capillary blood measuremen...
Eligibility Criteria
Inclusion
- Are between the ages of 12-75 years
- Have been diagnosed with type 1 diabetes mellitus
- Use insulin to treat your diabetes
- Agree and are able to follow the study plans as described in this informed consent form.
Exclusion
- Are a pregnant woman or nursing mother
- Have skin conditions that could cause a problem wearing a glucose sensor on your abdomen (stomach area) and/or having spectral data measured from your forearm with the non-invasive device.
- Are currently taking part in another clinical study
- Have taken part in this study before
- Have experienced severe hypoglycemia (an episode of low blood sugar that you were unable to treat yourself - e.g., seizure, coma, unconsciousness) any time within the past six months
- Have any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent you from completing the study
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01831752
Start Date
February 1 2013
End Date
June 1 2014
Last Update
November 18 2014
Active Locations (1)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105