Effect of the FreeStyle Libre 2 Flash Glucose Monitoring System on Hyperglycemia in People With T2 Diabetes

Study Overview
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Brief Summary
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A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System to the current standard of care (SMBG, self-monitoring of blood glucose) on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

Detailed Description
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Up to approximately 350 subjects will be enrolled to obtain a minimum of 130 randomized subjects, with a minimum of approximately 65 subjects per arm. At least 50% of randomized subjects will be age 65 and older. Subjects will be randomized to use either the FreeStyle Libre 2 Flash Glucose Monitoring System or traditional SMBG to manage their diabetes. The subsequent impact of FreeStyle Libre 2 versus SMBG on reducing the amount of time spent above 180 mg/dL will be assessed. 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.

Official Title
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Use of the FreeStyle Libre 2 Flash Glucose Monitoring System to Reduce Hyperglycemia in People With T2 Diabetes

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: SMBG Meter
* Device: FreeStyle Libre 2 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be at least 18 years of age. Subject must have HbA1c of > 7.5% at screening Subject has 35% or more time spent above 180 mg/dL during the screening phase. Subject must have had a diagnosis of type 2 diabetes for at least six (6) months prior to enrollment. Subject has been prescribed at least one capillary blood test every day for self-management of blood glucose (SMBG) to manage their diabetes. Subject must be on at least one (1) oral anti-diabetes medication. 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 is willing to make diet and lifestyle changes in response to education and glucose data Subject must be available to participate in all study visits. Subject must be willing and able to provide written signed and dated informed consent. Exclusion Criteria: Subject is currently on any form of insulin therapy. Subject has used an unblinded continuous glucose monitor (CGM) in the 3 months prior to enrollment. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only). 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. 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. Subject is currently undergoing dialysis and/or has end stage renal disease. Subject is currently participating in another interventional clinical trial. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SMBG, self-monitoring of blood glucose<br>Subjects will be randomized to continue use traditional SMBG, self-monitoring of blood glucose, to manage their diabetes. | Device: SMBG Meter<br>* Self Monitoring Blood Glucose Meter<br>|
| FreeStyle Libre 2<br>Subjects will be randomized to use the FreeStyle Libre 2 Flash Glucose Monitoring System to manage their diabetes. | Device: FreeStyle Libre 2 System<br>* The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on time above 180 mg/dL in subjects with type 2 diabetes | To assess the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System on time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen when compared to the current standard of care (SMBG, self-monitoring of blood glucose). | Six (6) months |