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

Abbott

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: FreeStyle Libre System; Device: FreeStyle Libre System plus food app

Study type: Interventional

Funder types: Industry

Identifiers

NCT04843527

ADC-US-RES-19185

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

FreeStyle Libre

Active Comparator group

Description:

Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.

Treatment:

Device: FreeStyle Libre System

FreeStyle Libre plus food logging

Active Comparator group

Description:

Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.

Treatment:

Device: FreeStyle Libre System plus food app