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

Completed

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID: NCT02336945
Run by: Abbott Diabetes Care
People needed: 146
Starts: 2015-01-01
Expected to finish: 2015-07-01
Last updated by the study team: 2017-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must be at least 18 years of age.
Subject must have diagnosis of type 2 diabetes prior to enrollment.
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).
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.
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%.
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.
If no HbA1c taken within the last six months is available, a new laboratory HbA1c value must be obtained prior to Sensor application.
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
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.
Subject must be available to participate in all study visits.
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, is attempting to conceive or is 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 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.
HbA1c of less than 6.0% or greater than 12.0% as demonstrated by lab HbA1c result obtained within the last 6 months.
Enrollment goal of Subject's intended therapy group has been met.
Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Subject is currently on one of the following treatments or treatment combinations:
Metformin + Sulfonylurea + DPP-4 Inhibitor
Sulfonylurea + DPP-4 Inhibitor
Metformin + Sulfonylurea + GLP-1 Receptor Agonist
Sulfonylurea + GLP-1 Receptor Agonist
Metformin + Sulfonylurea + SGLT-2
Sulfonylurea + SGLT-2
Metformin + SGLT-2 + Insulin
SGLT-2 + Insulin
NPH Insulin (with exception of NPH insulin present in premix formulations)
Rapid acting insulin (with exception of rapid acting insulin present in premix formulations)
Four (4) or more diabetes therapies

Where it is running

Unger Primary Care Medical Center & Catalina Research Institute — Chino, California, United States
Dr. Deanna Cheung — Long Beach, California, United States
University of California San Diego Veterns Affairs Medical Center — San Diego, California, United States
Henry Ford Medical Center — Detroit, Michigan, United States
St. Luke's Endocrinology and Diabetes — Kansas City, Missouri, United States
Duke Southern Regional AHEC — Fayetteville, North Carolina, United States
Diabetes America- Pearland — Pearland, Texas, United States

Full record on ClinicalTrials.gov

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