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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02336945
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Device: Abbott Sensor Based Glucose Monitoring System-Professional

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional
Study Start Date : January 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Groups and Cohorts
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Group/Cohort Intervention/treatment
Type 2 diabetes
Subjects with type 2 diabetes who meet one of the therapy conditions
 Device: Abbott Sensor Based Glucose Monitoring System-Professional
Subjects will wear 2 glucose sensors while going about daily activities and adhering to establish diabetes treatment plan. This is not a treatment study.
Other Name: FreeStyle Libre Pro


Outcome Measures
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Primary Outcome Measures :
  1. Glucose variability as measured by AGP Interquartile Range, (IQR) obtained via System-Pro Sensor. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Assessment of ambulatory glucose profiles (AGPs) generated by the Software [ Time Frame: 2 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 2 diabetes who meet one of the therapy groups
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336945


Locations
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United States, California
Unger Primary Care Medical Center & Catalina Research Institute
Chino, California, United States, 91710
Dr. Deanna Cheung
Long Beach, California, United States, 90807
University of California San Diego Veterns Affairs Medical Center
San Diego, California, United States, 92161
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
United States, Missouri
St. Luke's Endocrinology and Diabetes
Kansas City, Missouri, United States, 64111
United States, North Carolina
Duke Southern Regional AHEC
Fayetteville, North Carolina, United States, 28304
United States, Texas
Diabetes America- Pearland
Pearland, Texas, United States, 77584
Sponsors and Collaborators
Abbott Diabetes Care
More Information
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02336945    
Other Study ID Numbers: ADC-US-RES-14137
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: August 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases