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

NCT04843527 | Unknown FDA Device

• 1 other identifier: ADC-US-RES-19185
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

FreeStyle Libre

ACTIVE COMPARATOR

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

Device: FreeStyle Libre System

FreeStyle Libre plus food logging

ACTIVE COMPARATOR

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

Interventions

FreeStyle Libre System DEVICE

FreeStyle Libre Flash Glucose Monitoring System

FreeStyle Libre

FreeStyle Libre System plus food app DEVICE

FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application

FreeStyle Libre plus food logging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (4)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

UMPC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shridhara A Karinka, PhD

  Abbott Diabetes Care Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 13, 2021
• Study Start: April 2, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)