NCT01247649

Brief Summary

The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

3 months

First QC Date

November 21, 2010

Last Update Submit

November 18, 2012

Conditions

Type 1 Diabetes

Keywords

Continuous glucose monitoring systemNon invasiveType 1 diabetesDielectric spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument)

    Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels

    up to 24 weeks

Study Arms (1)

Study group

EXPERIMENTAL

Patients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each

Device: Physical Logic Continuous Glucose Monitoring System

Interventions

Physical Logic Continuous Glucose Monitoring SystemDEVICE

Patients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each

Study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signing an inform consent form
  • Age \> 18 years old
  • Willing to perform all study related procedures

You may not qualify if:

  • Known or suspected allergy to the sensor or one of its components
  • Psychiatric disorder
  • Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
  • Patients who are not willing or are not capable of performing the protocol requirements
  • Participating in another study that includes investigational drug or investigational equipment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Revital Nimri, Dr

    Schenider Children's Medical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2010

First Posted

November 24, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

IL(1)