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Trial record 1 of 1 for:    NCT02073058
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Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073058
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Brief Summary:
The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.

Condition or disease Intervention/treatment
Type 1 Diabetes Type 2 Diabetes Device: No treatment

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
Study Start Date : February 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical point accuracy as assessed by the Consensus Error Grid [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Safety endpoints that include signs and symptoms related to sensor application site [ Time Frame: 14 days ]
  2. Composite measure: Technical point accuracy (difference measures, Bland-Altman analysis, regression and percentage within ranges of the reference) [ Time Frame: 14 days ]
  3. Composite measure: Clinical point accuracy (Clarke Error Grid), trend accuracy (R-deviation, Rate Error Grid and Continuous Glucose Error Grid) and lag time, performance of notifications (sensitivity and false notifications) and questionnaire responses. [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 1 or type 2 diabetes who require multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII). No more than 20 subjects will have HbA1c > 8.5%, and no more than 20 subjects 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.
  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 (applicable to female subjects only).
  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 (3.7 months) 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

  7. Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding.
  8. 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.
  9. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073058


Locations
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United States, California
AMCR Institute
Escondido, California, United States, 92026
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Principal Investigator: Timothy Bailey, MD AMCR Institute
Principal Investigator: Bruce Bode, MD Atlanta Diabetes Associates
Principal Investigator: Mark Christiansen, MD Diablo Clinical Research
Principal Investigator: Leslie Klaff, MD Rainier Clinical Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02073058    
Other Study ID Numbers: ADC-US-VAL-13128
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014
Keywords provided by Abbott Diabetes Care:
Subjects with Type 1 or Type 2 Diabetes Requiring Multiple daily Insulin Injection (MDI) or Continuous Subcutaneous Insulin Infusion (CSII)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases