Overview

This trial is active, not recruiting.

Condition diabetes mellitus type 1
Treatment glucometer gm-205
Sponsor GlucoVista
Start date September 2012
End date July 2014
Trial size 20 participants
Trial identifier NCT01508065, gluco01

Summary

Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, 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 GM-205 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 GM-205 in evaluating blood glucose levels

2. The accuracy of the Glucometer GM-205 in evaluating blood glucose levels

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
glucometer gm-205
The study procedure consists of two days trial. Each day consists of 4-6 hours, during which, hyper and hypoglycaemic clamp will be done. The first day will be used to calibrate the non-invasive Glucometer GM-205 for the specific patient.. The calibration will be done using the hexokinase assay (YSI 2300 STAT Plus) from the venous. During the second day, hyper and hypo glycemic clamp will be done and the results of blood glucose level reading from the non-invasive

Primary Outcomes

Measure
assess the accuracy of the Glucometer GM-205 blood glucose
time frame: the study is consist of two parts, each part lasts a few hours.

Secondary Outcomes

Measure
The safety of the Glucometer GM-205 in evaluating blood glucose levels
time frame: the study is consist of two parts, each part lasts a few hours.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Ages: 18 to 65 2. Males- not involved in active military duty. 3. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent. Exclusion Criteria: 1. Active systemic or local infection. 2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)

Additional Information

Official title Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by GlucoVista.