Effect of the FreeStyle Libre 2 Flash Glucose Monitoring System on Hyperglycemia in People With T2 Diabetes
Use of the FreeStyle Libre 2 Flash Glucose Monitoring System to Reduce Hyperglycemia in People With T2 Diabetes
1 other identifier
observational
358
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2020
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedJuly 21, 2023
July 1, 2023
2.4 years
October 21, 2020
July 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
SMBG, self-monitoring of blood glucose
Subjects will be randomized to continue use traditional SMBG, self-monitoring of blood glucose, to manage their diabetes.
FreeStyle Libre 2
Subjects will be randomized to use the FreeStyle Libre 2 Flash Glucose Monitoring System to manage their diabetes.
Interventions
The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System
Eligibility Criteria
Adult subjects with type 2 diabetes diagnosis currently on oral anti-diabetes medication(s).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Valley Research
Fresno, California, 93720, United States
CEDE (Center of Excellence in Diabetes and Endocrinology)
Sacramento, California, 95821, United States
Metabolic Research Institute
West Palm Beach, Florida, 33401, United States
Billings Clinic
Billings, Montana, 59101, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shridhara A Karinka, PhD
Abbott Diabetes Care Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2020
First Posted
October 27, 2020
Study Start
October 20, 2020
Primary Completion
February 28, 2023
Study Completion
March 30, 2023
Last Updated
July 21, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share