Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device (CR-01-001)

Integrity Applications

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Device: GlucoTrack

Study type: Interventional

Funder types: Industry

Identifiers

NCT00889668

CR-01-001 CTIL

Details and patient eligibility

About

Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics.

The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels.

The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes

Full description

See Brief summary

Enrollment: 180 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1or 2 Diabetes
• Anatomically suitable earlobe

Exclusion criteria

• Subjects requiring dialysis
• Any conditions that may hamper good contact between the PEC and the earlobe
• Pregnancy
• Nursing mothers

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Experimental

Experimental group

Description:

subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device.

Treatment:

Device: GlucoTrack