Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/25/2017
Start Date:January 2015
End Date:July 2015

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This is a multi-center, prospective, non-pivotal, single arm, non-significant risk
evaluation the Abbott Sensor Based Glucose Monitoring System - Pro across different stages
of T2 diabetes management. This is a non-significant risk study.

Subjects will wear two Sensors, one applied to the back of each upper arm, for a period of
14 days. Subjects will wear the Sensor while going about their normal daily activities
during the home use period. Subjects will not be able to see any glucose data. The devices
will be removed at the completion of the final study visit.

Data obtained from the Reader and reports generated by the system will not be used by the
subject or the research team members to determine treatment. Subjects must adhere to their
diabetes clinical management plan established prior to the study.

No additional medical care will be provided to study subjects following study completion
other than care related to the follow up and treatment of adverse events.

Inclusion Criteria:

1. Subject must be at least 18 years of age.

2. Subject must have diagnosis of type 2 diabetes prior to enrollment.

3. Subject must have been on current treatment regimen for at least 6 months prior to
enrollment and must remain on therapy regimen for the duration of the study (subjects
diagnosed within last 6 months must be on no medication both prior to and throughout
the study to enroll).

4. HbA1c greater than or equal to 6.0% or less than or equal to 12.0% as demonstrated by
lab HbA1c result obtained within the last 6 months.

1. Subjects with HbA1c <7.5% will be excluded from the study if the subject's
intended therapy group for enrollment requires an HbA1c ≥7.5%.

2. For therapy groups enrolling 12 subjects with HbA1c of <7.5% and 12 subjects
with HbA1c of ≥7.5%, subjects with an HbA1c level within each respective range
will be excluded from the study once the enrollment goal of that HbA1c range has
been met.

3. If no HbA1c taken within the last six months is available, a new laboratory
HbA1c value must be obtained prior to Sensor application.

5. Subject must be able to read and understand English.

6. 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

7. In the investigators opinion, the subject must be compliant with their diabetes
management plan and must be able to adhere to medication regimen throughout study.

8. Subject must be available to participate in all study visits.

9. 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, is attempting to conceive or is 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 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.

6. HbA1c of less than 6.0% or greater than 12.0% as demonstrated by lab HbA1c result
obtained within the last 6 months.

7. Enrollment goal of Subject's intended therapy group has been met.

8. Subject is unsuitable for participation due to any other cause as determined by the
Investigator.

9. Subject is currently on one of the following treatments or treatment combinations:

1. Metformin + Sulfonylurea + DPP-4 Inhibitor

2. Sulfonylurea + DPP-4 Inhibitor

3. Metformin + Sulfonylurea + GLP-1 Receptor Agonist

4. Sulfonylurea + GLP-1 Receptor Agonist

5. Metformin + Sulfonylurea + SGLT-2

6. Sulfonylurea + SGLT-2

7. Metformin + SGLT-2 + Insulin

8. SGLT-2 + Insulin

9. NPH Insulin (with exception of NPH insulin present in premix formulations)

10. Rapid acting insulin (with exception of rapid acting insulin present in premix
formulations)

11. Four (4) or more diabetes therapies
We found this trial at
7
sites
Fayetteville, North Carolina 28304
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Fayetteville, NC
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Chino, CA
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Detroit, Michigan 48202
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Detroit, MI
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Kansas City, Missouri 64111
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Kansas City, MO
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Long Beach, California 90807
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Long Beach, CA
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Pearland, Texas 77584
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Pearland, TX
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34800 Bob Wilson Drive
San Diego, California 92161
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San Diego, CA
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