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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04843527
• Other study ID #: ADC-US-RES-19185
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperglycemia

Intervention

Device:
• FreeStyle Libre System
FreeStyle Libre Flash Glucose Monitoring System
• FreeStyle Libre System plus food app
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Henry Ford Health System	Detroit	Michigan
United States	HealthPartners Institute dba International Diabetes Center	Minneapolis	Minnesota
United States	UMPC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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