Accuracy Characterization Study (ACS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT01932944
First received: August 28, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring System (System) interstitial glucose results against venous glucose reference and capillary fingerstick using the Consensus Error Grid over the wear duration. During the course of the wear duration, the subject is required to be testing fingerstick glucose measurement at least 8 times a day for capillary reference glucose measurements and three in-clinic visits of maximum 10 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.


Condition Intervention
Subjects With Type 1 or Type 2 Diabetes Requiring Multiple Daily Insulin Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII).
Device: No treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System Compared to Venous and Capillary Glucose

Resource links provided by NLM:


Further study details as provided by Abbott Diabetes Care:

Primary Outcome Measures:
  • Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System compared to venous and capillary glucose [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against venous glucose reference (YSI) using the Consensus Error Grid.


Enrollment: 30
Study Start Date: August 2013
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment Device: No treatment

  Eligibility

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

Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII). No more than 10 subjects (5 per site) will have HbA1c > 8.5%, and no more than 10 subjects (5 per site) will have HbA1c < 7% based on the subject screening.

Criteria

Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
  3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment.
  4. Subject must be able to read and understand English.
  5. In the Investigator's opinion, the Subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
  6. Subject must be available to participate in all study visits up to a period of 14 days.
  7. Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

  1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  2. Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration.
  3. Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
  4. Subject currently is participating in another clinical trial.
  5. Subject has donated blood within 112 days prior to the beginning of the study activities.
  6. Subject has concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the Subject or study staff. Such conditions include but are not limited to:

    • History of HIV, Hepatitis B or C, or other blood-borne pathogen;
    • Subject has an increased risk of bleeding.
    • Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
    • Subject is unsuitable for participation due to any other cause as determined by the Investigator.
  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: NCT01932944

Locations
United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Washington
Rainier Clinical Research Center
Rainier, Washington, United States, 98057
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Principal Investigator: Mark Christiansen, M.D. Diablo Clinical Research
Principal Investigator: Leslie Klaff, M.D. Rainier Clinical Research Center
  More Information

No publications provided

Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT01932944     History of Changes
Other Study ID Numbers: ADC13-126
Study First Received: August 28, 2013
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014