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Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device

I

Integrity Applications

Status

Unknown

Conditions

Gestational Diabetes
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Treatments

Device: GlucoTrack

Study type

Interventional

Funder types

Industry

Identifiers

NCT00433758
IA-A2-2007-01-CTIL

Details and patient eligibility

About

The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels

Full description

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. Consistently high blood sugar levels can, over time, lead to complications such as blindness, kidney disease, heart disease, and nerve damage.In addition, low blood sugars may lead to immediate dangers. 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. Currently, there is no commercially available reliable non-invasive glucose measurement device that being marketed.

The GlucoTrack, non-invasive device for determining glucose levels based on the simultaneous measurement of three independent orthogonal parameters.

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

Enrollment

142 estimated patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with Type 1, Type 2, or Gestational Diabetes
  • Above the age of 10

Exclusion criteria

  • Does not meet inclusion criteria
  • Patients requiring dialysis
  • Participation in other clinical investigations within the previous month.
  • Pregnancy(excluding patients that intend to participate in the gestational group)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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