Accuracy Characterization Study (ACS)

Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System Compared to Venous and Capillary Glucose

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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes; Type2 Diabetes; Insulin Dependent Diabetes
• Intervention / Treatment: Device: No treatment

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Washington
    • Rainier, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment	Device: No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System compared to venous and capillary glucose	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.	14 days

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Principal Investigator: Mark Christiansen, M.D., Diablo Clinical Research; Principal Investigator: Leslie Klaff, M.D., Rainier Clinical Research Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: ADC13-126