- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135771
Performance Study Using the OptiScanner on Healthy Diabetics
June 2, 2010 updated by: Profil Institut für Stoffwechselforschung GmbH
This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement.
The accuracy of the test device will be determined using plasma samples collected directly from Type 1 and Type 2 Diabetics using the OptiScanner.
Blood samples will simultaneously be collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated.
These results will be compared to the OptiScanner's glucose measurement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Neuss, Germany, 41460
- Profil Institut für Stoffwechselforschung
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have signed an Informed Consent Form for this study approved by the Institutional Review Board (IRB)
- Have a documented onset of diabetes ³ 1 year prior to this study
- Have Type 1 or Type 2 diabetes according to the American Diabetes Association diagnostic criteria
- Be currently treated with insulin (all regimens) for ³ 1 year and able (as judged by Investigator) and willing to undergo a hypoglycemic challenge and a hyperglycemic challenge; oral diabetes medication in combination with insulin is allowed
- Be at least 18 but no more than 65 years of age
- Be willing and able to comply with the requirements of the protocol
- Be willing to refrain from participating in any other investigational study while enrolled in this study
- For Female Subjects: Be post-menopausal, sterilized or not of child-bearing potential, or have a negative pregnancy test and have no intention of becoming pregnant between Visit 1 and Visit 2, and be using contraceptive devices or drugs (risk of pregnancy must be lower than 1%).
Exclusion Criteria:
- Recurrent major hypoglycemia (as judged by the Investigator) or hypoglycemia requiring hospitalization within the last 12 months
- Have a history of hypoglycemic seizure within the last year
- Impaired hepatic function measured as AST/ALT ³ two and a half times the upper reference limit or total bilirubin two and a half times the upper reference limit based on analysis from the local laboratory, or at the Investigator's discretion
- Impaired renal function measured as creatinine ³ 1.5 (females) mg/dL, ³ 1.7 (males) mg/dL based on analysis from the local laboratory, or at the Investigator's discretion
- Haematocrit or electrolytes (sodium, potassium) outside of normal limits based on analysis from the local laboratory, or at the investigator's discretion.
- Have Uric Acid > 10 mg/dL based on analysis from the local laboratory
- HIV positive, or Hepatitis B or C positive (blood test required). A viral load test will be done at the local laboratory for subjects with a positive Hepatitis result.
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Have a history of angina requiring hospitalization or a myocardial infarction within the last 12 months
- Evidence of intermittent or sustained ventricular or supra-ventricular arrhythmias such as ventricular tachycardia, atrial fibrillation, etc. Holter monitoring may be performed to exclude arrhythmias at the discretion of the investigator.
- Uncontrolled treated/untreated hypertension (systolic blood pressure ³ 160 mmHg and/or diastolic blood pressure ³ 100 mmHg)
- Have active diabetic proliferative retinopathy (undergoing treatment)
- Have active significant recurring skin infections or adhesive allergies, at the Investigator's discretion
- Have given more than 150 mL of blood within 8 weeks prior to enrollment in this study
- Currently taking anticoagulants, e.g. Coumadin (warfarin), Marcumar (phenprocoumon). Patients with prolonged activated PTT will not be included in this study.
- Have received any investigational product or been treated with an invasive device within the past 30 days
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
- Any chronic illness that, in the judgment of the Investigator, may hinder or confuse compliance with the protocol
- Any condition (may include clinically significant screening laboratory assessments) which, in the judgement of the Investigator, may increase the risk to the subject or decrease the likelihood of achieving the objectives of the study
- Pregnancy or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in otherwise healthy diabetic subjects when compared to blood glucose levels simultaneously measured on the YSI
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Secondary Outcome Measures
Outcome Measure |
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The secondary objective of the study is to demonstrate a blood glucose measurement range of 60 to 500 mg/dL at the hematocrit levels referenced as normal
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
June 2, 2010
First Submitted That Met QC Criteria
June 2, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Estimate)
June 3, 2010
Last Update Submitted That Met QC Criteria
June 2, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1003106
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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