Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System

Type 2 Diabetes Clinical Trial

Official title:

Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073058
• Other study ID #: ADC-US-VAL-13128
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: May 22, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• No treatment

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	AMCR Institute	Escondido	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical point accuracy as assessed by the Consensus Error Grid		14 days	No
Secondary	Safety endpoints that include signs and symptoms related to sensor application site		14 days	Yes
Secondary	Composite measure: Technical point accuracy (difference measures, Bland-Altman analysis, regression and percentage within ranges of the reference)		14 days	No
Secondary	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.		14 days	No