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Completed

NCT Number: NCT01932944

Accuracy Characterization Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diablo Clinical Research, Walnut Creek, California, United States

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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 up to a period of 14 days.
  • 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.
  • 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 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, 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.

Treatment and study plan

No treatment

Device

Primary outcomes

  1. Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System compared to venous and capillary glucose

    Time frame: 14 days

    To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against venous glucose reference (YSI) using the Consensus Error Grid.

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System Compared to Venous and Capillary Glucose

Acronym: ACS

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Aug 30, 2013
Registry last updated
Jan 24, 2017

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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