Clinical trial NCT01932944: Accuracy Characterization Study
Official title: Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System Compared to Venous and Capillary Glucose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Type1diabetes
Insulin Dependent Diabetes
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2013-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System compared to venous and capillary glucose
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Rainier
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Diablo Clinical Research
name: Mark Christiansen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainier Clinical Research Center
name: Leslie Klaff, M.D.
role: PRINCIPAL_INVESTIGATOR
References: