Clinical trial NCT02073058: Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
Official title: Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Subjects with Type 1 or Type 2 Diabetes Requiring Multiple daily Insulin Injection (MDI) or Continuous Subcutaneous Insulin Infusion (CSII)
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 75
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 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.

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.


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.
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.

Primary outcomes:
measure: Clinical point accuracy as assessed by the Consensus Error Grid
timeFrame: 14 days
Secondary outcomes:
measure: Safety endpoints that include signs and symptoms related to sensor application site
timeFrame: 14 days
measure: Composite measure: Technical point accuracy (difference measures, Bland-Altman analysis, regression and percentage within ranges of the reference)
timeFrame: 14 days
measure: 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.
timeFrame: 14 days
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Diabetes Associates
name: Bruce Bode, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diablo Clinical Research
name: Mark Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainier Clinical Research
name: Leslie Klaff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 2015 Nov;17(11):787-94. doi: 10.1089/dia.2014.0378. Epub 2015 Jul 14.