A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01464346
First received: November 1, 2011
Last updated: May 24, 2012
Last verified: May 2012
  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 Intervention
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Device: Enlite Sensor

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:

Enrollment: 90
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 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
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: NCT01464346

Locations
United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
AMCR Institue
Escondido, California, United States, 92026
University of California, San Diego
La Jolla, California, United States, 92093
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado Denver/Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
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: May 24, 2012
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 August 18, 2014