Effect of the FreeStyle Libre 2 Flash Glucose Monitoring System on Hyperglycemia in People With T2 Diabetes
NCT ID: NCT04604093
Last Updated: 2023-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
358 participants
OBSERVATIONAL
2020-10-20
2023-03-30
Brief Summary
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Detailed Description
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Safety of the FreeStyle Libre 2 Flash Glucose Monitoring System and SMBG will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SMBG, self-monitoring of blood glucose
Subjects will be randomized to continue use traditional SMBG, self-monitoring of blood glucose, to manage their diabetes.
SMBG Meter
Self Monitoring Blood Glucose Meter
FreeStyle Libre 2
Subjects will be randomized to use the FreeStyle Libre 2 Flash Glucose Monitoring System to manage their diabetes.
FreeStyle Libre 2 System
The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System
Interventions
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SMBG Meter
Self Monitoring Blood Glucose Meter
FreeStyle Libre 2 System
The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System
Eligibility Criteria
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Inclusion Criteria
2. Subject must have HbA1c of \> 7.5% at screening
3. Subject has 35% or more time spent above 180 mg/dL during the screening phase.
4. Subject must have had a diagnosis of type 2 diabetes for at least six (6) months prior to enrollment.
5. Subject has been prescribed at least one capillary blood test every day for self-management of blood glucose (SMBG) to manage their diabetes.
6. Subject must be on at least one (1) oral anti-diabetes medication.
7. Subject must be able to read and understand English.
8. 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.
9. Subject is willing to make diet and lifestyle changes in response to education and glucose data
10. Subject must be available to participate in all study visits.
11. Subject must be willing and able to provide written signed and dated informed consent.
Exclusion Criteria
2. Subject has used an unblinded continuous glucose monitor (CGM) in the 3 months prior to enrollment.
3. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
4. Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
5. Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.
6. Subject has concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.
7. Subject is currently undergoing dialysis and/or has end stage renal disease.
8. Subject is currently participating in another interventional clinical trial.
9. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
18 Years
ALL
No
Sponsors
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Abbott Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Shridhara A Karinka, PhD
Role: STUDY_DIRECTOR
Abbott Diabetes Care Inc
Locations
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Valley Research
Fresno, California, United States
CEDE (Center of Excellence in Diabetes and Endocrinology)
Sacramento, California, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Billings Clinic
Billings, Montana, United States
Palm Research Center
Las Vegas, Nevada, United States
Countries
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Other Identifiers
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ADC-US-RES-20193
Identifier Type: -
Identifier Source: org_study_id
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