NCT01932944

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

August 28, 2013

Last Update Submit

January 23, 2017

Conditions

Type2 DiabetesType1diabetesInsulin Dependent Diabetes

Outcome Measures

Primary Outcomes (1)

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

    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.

    14 days

Study Arms (1)

No treatment

Device: No treatment

Interventions

No treatmentDEVICE
No treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with type 1 or type 2 diabetes requiring multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII). No more than 10 subjects (5 per site) will have HbA1c \> 8.5%, and no more than 10 subjects (5 per site) will have HbA1c \< 7% based on the subject screening.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Rainier Clinical Research Center

Rainier, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mark Christiansen, M.D.

    Diablo Clinical Research

    PRINCIPAL INVESTIGATOR

  • Leslie Klaff, M.D.

    Rainier Clinical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

August 30, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2013

Study Completion

March 1, 2014

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

US(2)