A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours
FAS
1 other identifier
interventional
12
1 country
1
Brief Summary
The goal of this clinical research study is to learn about a new minimally invasive glucose monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be used to determine its effectiveness for glucose monitoring. Researchers want to find out how the device performs at two different body sites (forearm and abdomen) over 4 hours. The safety and comfort level of the device will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Nov 2009
Longer than P75 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 4, 2016
February 1, 2016
2.6 years
February 8, 2010
February 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
examine accuracy of FAS response to glucose changes in subcutaneous tissue (compared to blood glucose concentrations measured with reference method)
3 months
monitor safety and performance of FAS response in two different body sites (abdomen, forearm)
3 months
Secondary Outcomes (2)
examine insertion site while the FAS is worn, and after seven days of FAS removal
3 months
assess comfort level during FAS insertion, when worn during normal activities, and during FAS removal
3 months
Study Arms (1)
Patients
EXPERIMENTALInterventions
monitor interstitial glucose level every 5 min over 4 hours
Eligibility Criteria
You may qualify if:
- Female and male patients with Type I and II diabetes requiring injectable insulin from age 18-80.
You may not qualify if:
- Patients with fasting glucose concentration larger than 200 mg/dL will be excluded from the study.
- Children under the age of 18 will not be included because Texas state law would not allow such participants to give informed consent on their own.
- Patients who are required to take certain medications including corticosteroids, diuretics, anticonvulsants, birth-control pills, non-steroidal anti-inflammatory drugs (NSAIDs) and certain high-blood pressure medications will be excluded from the study.
- Pregnant women or any patient who cannot participate in an oral glucose tolerance test will also be excluded from the study. Presence of pacemaker or defibrillator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioTex, Inc.lead
- Endocrinoloogy Associates Houstoncollaborator
Study Sites (1)
Practice of Eric Orzeck, MD
Houston, Texas, 77025, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Dutt-Ballerstadt, Ph.D.
BioTex, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 10, 2010
Study Start
November 1, 2009
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
February 4, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will share