NCT01508065

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

January 9, 2012

Last Update Submit

February 18, 2019

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • 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.

Study Arms (1)

controlled type one diabetes mellitus.

Device: Glucometer CGM-305

Interventions

Glucometer CGM-305DEVICE

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.

controlled type one diabetes mellitus.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient population will include subjects with controlled type one diabetes mellitus.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Hadassah Medical Organization

Jerusalem, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Hadas Lamberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 11, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations

IL(2)