Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device

GlucoVista

Status: Unknown

Conditions: Diabetes Mellitus Type 1

Treatments: Device: Glucometer CGM-305

Study type: Observational

Funder types: Industry

Identifiers

NCT01508065

gluco01

Details and patient eligibility

About

Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that can be achieved with a true non-invasive device offering the likelihood of continuous glucose monitoring. Currently, glucose is best monitored by measuring capillary blood from the fingertips, from venous/arterial line blood samples and from a daily calibrated Subcutaneous Blood Glucose Monitor (SBGM) which is a source of severe inconvenience and hence, a lack of compliance.

Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.

The Glucometer CGM-305 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.

The primary objectives of the trial are to determine:

1. The safety of the Glucometer CGM-305 in evaluating blood glucose levels
2. The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 Diabetic patient.
• Ages: 18 to 65.
• Signed informed consent.
• HbA1c of 6%-9% at screening.
• Males- not involved in active military duty.
• Females-non-child bearing potential or females of child-bearing potential who have a negative pregnancy test (HCG in blood or urine) within 72 hours of informed consent.

Exclusion criteria

• Active systemic or local infection.
• Any medical condition that, by the investigator judgment, will increase the risk from Hyper and Hypo-Glycemic experiment: seizures, heart disease, hypoglycemia unawareness etc.
• History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)

Trial design

20 participants in 1 patient group

controlled type one diabetes mellitus.

Treatment:

Device: Glucometer CGM-305