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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: SMBG Meter; Device: FreeStyle Libre 2 System

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.

• Study Type: Observational
• Enrollment (Actual): 358

Contacts and Locations

• Study Contact: Name: Mohamed Nada, PhD; Phone Number: (510) 749 5416; Email: ADC.Clinical@abbott.com

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Valley Research
    • Sacramento, California, United States, 95821
      • CEDE (Center of Excellence in Diabetes and Endocrinology)
  • Florida
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with type 2 diabetes diagnosis currently on oral anti-diabetes medication(s).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SMBG, self-monitoring of blood glucose; Subjects will be randomized to continue use traditional SMBG, self-monitoring of blood glucose, to manage their diabetes.	Device: 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.	Device: FreeStyle Libre 2 System; The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Study Director: Shridhara A Karinka, PhD, Abbott Diabetes Care Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus
• Other Study ID Numbers: ADC-US-RES-20193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No