Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes

Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People

A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application 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: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: FreeStyle Libre System; Device: FreeStyle Libre System plus food app

Detailed Description

Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.

The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • HealthPartners Institute dba International Diabetes Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UMPC

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subject must be at least 18 years of age.
• Subject has been diagnosed with type 2 diabetes.
• HbA1c greater than or equal to 7.5% and less than or equal to 12%
• Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
• Subject owns a compatible smartphone
• Subject agrees to a 3-month period of no diabetes medication changes.
• Subject is willing to make diet and lifestyle changes in response to education and glucose data

Exclusion Criteria:

• Subject is currently on insulin therapy or sulfonylurea-based medications.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FreeStyle Libre; Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.	Device: FreeStyle Libre System; FreeStyle Libre Flash Glucose Monitoring System
Active Comparator: FreeStyle Libre plus food logging; Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.	Device: FreeStyle Libre System plus food app; FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on time above 180 mg/dL	To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL	Three (3) 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): April 2, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
• Other Study ID Numbers: ADC-US-RES-19185

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