Accuracy Evaluation of Abbott Sensor Based Interstitial Glucose Monitoring System
This study aims to evaluate the accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System by using the Consensus Error Grid, a tool to assess clinical point accuracy.
Data Collection
Collected from today forward - ProspectiveAutoimmune Diseases+6
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 1, 2014
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Diablo Clinical Research
Walnut Creek, United StatesAtlanta Diabetes Associates
Atlanta, United StatesRainier Clinical Research Center
Renton, United States