Diabetes Mellitus Type 1
Conditions
Brief summary
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
Interventions
DEVICEGlucometer CGM-305
The study procedure consists of three days trial. After each experimental day the results of blood glucose level reading from the non-invasive Glucometer CGM-305 will be compared to the reading from several devices, as following: Abbott Freestyle Libre, the hexokinase assay (YSI 2300 STAT Plus) from the venous and the laboratory blood measurements. First day of trial consists of 8-10 hours and is used to calibrate the non-invasive Glucometer CGM-305 for the specific patient. During the second and third days a fasting experiment is performed and consists of 4-6 hours.
Sponsors
GlucoVista
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device. | will be assessed after second experimental day |
| Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by correlation with values measured by glucose hexokinase based assay | will be assessed after second experimental day |
| Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by Clark error grid with measurements of venous blood as the comparing value | will be assessed after second experimental day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety of the Glucometer CGM-305 in evaluating blood glucose levels | The study consists of three days trial, first day lasts an 8-10 hours, second and third days last 4-6 hours. | Safety will be evaluated in a descriptive manner by recording all adverse events in the patient population by number and severity. The study will evaluate safety by assessing: 1. Device related adverse events: local and systemic effects of the Glucometer CGM-305 including: redness, burns, pain , or other complications. 2. General adverse events: Adverse events not directly related to the Glucometer CGM-305 device but are related to the study procedure (i.e clamping), such as: local infection, blood clot, bleeding, hypoglycemia. |
Countries
Israel
Contacts
Primary ContactHadas Lamberg, PhD
Outcome results
None listed