Performance Study Using the OptiScanner on Healthy Diabetics

This study has been completed.
Sponsor:
Collaborator:
OptiScan Biomedical Corporation
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT01135771
First received: June 2, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Other: glucose and insulin IV to alter blood glucose
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Performance Study Using the OptiScanner on Healthy Diabetics

Resource links provided by NLM:


Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have signed an Informed Consent Form for this study approved by the Institutional Review Board (IRB)
  2. Have a documented onset of diabetes ³ 1 year prior to this study
  3. Have Type 1 or Type 2 diabetes according to the American Diabetes Association diagnostic criteria
  4. 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
  5. Be at least 18 but no more than 65 years of age
  6. Be willing and able to comply with the requirements of the protocol
  7. Be willing to refrain from participating in any other investigational study while enrolled in this study
  8. 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:

  1. Recurrent major hypoglycemia (as judged by the Investigator) or hypoglycemia requiring hospitalization within the last 12 months
  2. Have a history of hypoglycemic seizure within the last year
  3. 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
  4. 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
  5. Haematocrit or electrolytes (sodium, potassium) outside of normal limits based on analysis from the local laboratory, or at the investigator's discretion.
  6. Have Uric Acid > 10 mg/dL based on analysis from the local laboratory
  7. 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.
  8. New York Heart Association (NYHA) Class III or IV congestive heart failure
  9. Have a history of angina requiring hospitalization or a myocardial infarction within the last 12 months
  10. 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.
  11. Uncontrolled treated/untreated hypertension (systolic blood pressure ³ 160 mmHg and/or diastolic blood pressure ³ 100 mmHg)
  12. Have active diabetic proliferative retinopathy (undergoing treatment)
  13. Have active significant recurring skin infections or adhesive allergies, at the Investigator's discretion
  14. Have given more than 150 mL of blood within 8 weeks prior to enrollment in this study
  15. Currently taking anticoagulants, e.g. Coumadin (warfarin), Marcumar (phenprocoumon). Patients with prolonged activated PTT will not be included in this study.
  16. Have received any investigational product or been treated with an invasive device within the past 30 days
  17. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
  18. Any chronic illness that, in the judgment of the Investigator, may hinder or confuse compliance with the protocol
  19. 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
  20. Pregnancy or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135771

Locations
Germany
Profil Institut für Stoffwechselforschung
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
OptiScan Biomedical Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tim Heise, Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01135771     History of Changes
Other Study ID Numbers: 1003106
Study First Received: June 2, 2010
Last Updated: June 2, 2010
Health Authority: Germany: Competent authority is Bezirksregierung Düsseldorf

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
glucose monitoring
diabetes
glucose monitoring in patients with diabetes

ClinicalTrials.gov processed this record on September 22, 2014