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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FreeStyle Libre System
FreeStyle Libre System plus food app
Sponsored by
Abbott Diabetes Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Boston Medical Center
  • Henry Ford Health System
  • HealthPartners Institute dba International Diabetes Center
  • UMPC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FreeStyle Libre

FreeStyle Libre plus food logging

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 9, 2021
Last Updated
June 30, 2023
Sponsor
Abbott Diabetes Care
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1. Study Identification

Unique Protocol Identification Number
NCT04843527
Brief Title
Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
Official Title
Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Diabetes Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FreeStyle Libre
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.
Arm Title
FreeStyle Libre plus food logging
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre System
Intervention Description
FreeStyle Libre Flash Glucose Monitoring System
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre System plus food app
Intervention Description
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
Primary Outcome Measure Information:
Title
Impact on time above 180 mg/dL
Description
To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL
Time Frame
Three (3) months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shridhara A Karinka, PhD
Organizational Affiliation
Abbott Diabetes Care Inc
Official's Role
Study Director
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
HealthPartners Institute dba International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
UMPC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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