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A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use
This study is currently recruiting participants.
Verified December 2011 by Medtronic Diabetes

First Received on November 1, 2011.   Last Updated on December 14, 2011   History of Changes
Sponsor: Medtronic Diabetes
Information provided by (Responsible Party): Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01464346
  Purpose

The purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.


Condition
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Estimated Enrollment: 90
Study Start Date: November 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 1 or type 2 diabetes mellitus adult subjects 18-75 years of age

Criteria

Inclusion Criteria:

  1. Subject is 18 - 75 years of age at time of screening
  2. A clinical diagnosis of type 1 or 2 diabetes as determined by the

    Investigator, for a minimum of 12 months duration:

    • Criteria for type 1 diabetes:

      • Required: Age of onset < 40 years of age
      • Required: History of insulin use only for management of diabetes
      • Required: history of normal weight or underweight at time of diagnosis.
      • Not required: Initial presentation of diabetic ketoacidosis.
      • Not required: History of diabetic ketoacidosis
      • Not required: Low fasting C-peptide
    • Criteria for type 2 diabetes:

      • Required: Age of onset ~ 40 years of age
      • Required: History of initial oral anti-diabetic use
      • Required: History of being overweight at time of diagnosis.

        • Type 2 insulin requiring is defined by type 2 diabetes subjects taking insulin with or without oral anti-diabetic agent and may also include: incretin mimetic, pramlintide or GLP agonist
        • Type 2 non-insulin requiring is defined by type 2 diabetes subjects who take oral medications and may also include: incretin mimetic, pramlintide or GLP agonist
  3. Adequate venous access as assessed by investigator or appropriate staff

Exclusion Criteria:

  1. Subject is unable to tolerate tape adhesive in the area of sensor placement.
  2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
  3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
  4. Subject has a positive pregnancy screening test
  5. Subject is female and plans to become pregnant during the course of the study
  6. Subject has had a hypoglycemic seizure within the past 6 months
  7. Subject has a history of a seizure disorder
  8. Subject has central nervous system or cardiac disorder resulting in syncope
  9. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
  10. Subjects with hematocrit lower than 36%
  11. SUbjects with a history of any cardiac arrhythmia, including atrial arrhythmias
  12. Subjects with a history of adrenal insufficiency
  13. Subjects with migraines
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464346

Locations
United States, California
Profil Institute for Clinical Research Recruiting
Chula Vista, California, United States, 91911
Contact: Elaine Watkins     866-308-7427     volunteer@profilinstitute.com    
Contact: Heidi Guthrie            
Principal Investigator: Elaine Watkins, DO, MSPH            
AMCR Institue Recruiting
Escondido, California, United States, 92026
Contact: Timothy Bailey, MD     760-466-1530     tbailey@amcrinstitute.com    
Contact: Jane Joaquin     760-466-1526     jjoaquin@amcrinstitute.com    
Principal Investigator: Timothy Bailey, MD            
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Mark Christiansen         mchristiansen@diabloclinical.com    
Principal Investigator: Richard Weinstein            
United States, Washington
Rainier Clinical Research Center Recruiting
Renton, Washington, United States, 98057
Contact: Ronald Brazg, MD     425-271-1720     rbrazg@rainier-research.com    
Contact: Kristin Hughes     425-271-1720 ext 15        
Principal Investigator: Ronald Brazg, MD            
Sponsors and Collaborators
Medtronic Diabetes
Investigators
Study Director: Scott Lee, MD Medtronic Diabetes
  More Information

No publications provided

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01464346     History of Changes
Other Study ID Numbers: CEP247
Study First Received: November 1, 2011
Last Updated: December 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Diabetes:
diabetes
glucose sensor
CGM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2012