Performance Evaluation of a Non-Invasive Glucose Monitor as Compared to CGM Data Acquired by the iPro2
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - 75 |
| Updated: | 2/7/2015 |
| Start Date: | February 2013 |
| End Date: | July 2013 |
| Contact: | Howard Zisser, MD |
| Email: | hzisser@sansum.org |
| Phone: | 805-682-7640 |
Performance Evaluation of a Non-Invasive Glucose Monitor (Spectral Data Acquisition) as Compared to CGM Data Acquired by the iPro2
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 to be drawn from the body, and it does not require a glucose sensor to be worn
under the skin (subcutaneously). This device instead estimates blood glucose levels by
shining infrared light on the skin and then using sophisticated statistical analysis on how
the light bounces back or gets absorbed (spectral data). The researchers in this study will
compare the accuracy of the new device to glucose measurement devices that are already
approved by the FDA, including glucose meters and subcutaneous continuous glucose monitoring
(CGM) sensors. Information learned from this study will be used in the development of tools
for managing diabetes.
to learn more about an investigational system to measure blood glucose. This system does not
require blood to be drawn from the body, and it does not require a glucose sensor to be worn
under the skin (subcutaneously). This device instead estimates blood glucose levels by
shining infrared light on the skin and then using sophisticated statistical analysis on how
the light bounces back or gets absorbed (spectral data). The researchers in this study will
compare the accuracy of the new device to glucose measurement devices that are already
approved by the FDA, including glucose meters and subcutaneous continuous glucose monitoring
(CGM) sensors. Information learned from this study will be used in the development of tools
for managing diabetes.
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 measurements taken nearly simultaneously with a series of near-infrared
spectra collected via a novel, proprietary fiber-optic probe. Simultaneously, subjects will
be wearing a commercial continuous glucose measuring system (Medtronic iPro 2). The spectral
data are converted to a prediction of tissue glucose using a proprietary pre-defined
universal algorithm. Subjects are tested every 20 minutes for up to 12 hours per day and up
to 6 visits per patient over a period of up to 4 months.
glucose sensing. The testing for each patient includes fingerstick and alternate site
capillary blood measurements taken nearly simultaneously with a series of near-infrared
spectra collected via a novel, proprietary fiber-optic probe. Simultaneously, subjects will
be wearing a commercial continuous glucose measuring system (Medtronic iPro 2). The spectral
data are converted to a prediction of tissue glucose using a proprietary pre-defined
universal algorithm. Subjects are tested every 20 minutes for up to 12 hours per day and up
to 6 visits per patient over a period of up to 4 months.
Inclusion Criteria:
- 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 Criteria:
- 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
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