Clinical trial NCT04604093: Effect of the FreeStyle Libre 2 Flash Glucose Monitoring System on Hyperglycemia in People With T2 Diabetes
Official title: Use of the FreeStyle Libre 2 Flash Glucose Monitoring System to Reduce Hyperglycemia in People With T2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with type 2 diabetes diagnosis currently on oral anti-diabetes medication(s).

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

1. Subject is currently on any form of insulin therapy.
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.

Primary outcomes:
measure: Impact on time above 180 mg/dL in subjects with type 2 diabetes
timeFrame: Six (6) months
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Research
state: California
city: Sacramento
country: United States
facility: CEDE (Center of Excellence in Diabetes and Endocrinology)
state: California
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
Study officials:
affiliation: Abbott Diabetes Care Inc
name: Shridhara A Karinka, PhD
role: STUDY_DIRECTOR
References: