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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AMCR Institute, Escondido, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject must be at least 18 years of age.
Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
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.
Subject must be able to read and understand English.
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.
Subject must be available to participate in all study visits.
Subject must be willing and able to provide written signed and dated informed consent.

Exclusion criteria

Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
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.
Subject currently is participating in another clinical trial.
Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
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
Subject has a known medical condition that, in the opinion of the investigator, may increase the 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.

Treatment and study plan

No treatment

Device

Primary outcomes

Clinical point accuracy as assessed by the Consensus Error Grid

Time frame: 14 days

Secondary outcomes

Safety endpoints that include signs and symptoms related to sensor application site

Time frame: 14 days
Composite measure: Technical point accuracy (difference measures, Bland-Altman analysis, regression and percentage within ranges of the reference)

Time frame: 14 days
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.

Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 27, 2014
Registry last updated: May 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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