Effect of the FreeStyle Libre 2 Flash Glucose Monitoring System on Hyperglycemia in People With T2 Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Use of the FreeStyle Libre 2 Flash Glucose Monitoring System to Reduce Hyperglycemia in People With T2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604093
• Other study ID #: ADC-US-RES-20193
• Status: Completed
• Start date: October 20, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2023
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System to the current standard of care (SMBG, self-monitoring of blood glucose) 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:

Up to approximately 350 subjects will be enrolled to obtain a minimum of 130 randomized subjects, with a minimum of approximately 65 subjects per arm. At least 50% of randomized subjects will be age 65 and older. Subjects will be randomized to use either the FreeStyle Libre 2 Flash Glucose Monitoring System or traditional SMBG to manage their diabetes. The subsequent impact of FreeStyle Libre 2 versus SMBG on reducing the amount of time spent above 180 mg/dL will be assessed.

Safety of the FreeStyle Libre 2 Flash Glucose Monitoring System and SMBG will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: March 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject must be at least 18 years of age.

2. Subject must have HbA1c of > 7.5% at screening

3. Subject has 35% or more time spent above 180 mg/dL during the screening phase.

4. Subject must have had a diagnosis of type 2 diabetes for at least six (6) months prior to enrollment.

5. Subject has been prescribed at least one capillary blood test every day for self-management of blood glucose (SMBG) to manage their diabetes.

6. Subject must be on at least one (1) oral anti-diabetes medication.

7. Subject must be able to read and understand English.

8. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.

9. Subject is willing to make diet and lifestyle changes in response to education and glucose data

10. Subject must be available to participate in all study visits.

11. Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

1. Subject is currently on any form of insulin therapy.

2. Subject has used an unblinded continuous glucose monitor (CGM) in the 3 months prior to enrollment.

3. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.

4. Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).

5. Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. Such conditions include, but are not limited to extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, dermatitis herpetiformis, skin lesions, redness, infection or edema.

6. Subject has concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff.

7. Subject is currently undergoing dialysis and/or has end stage renal disease.

8. Subject is currently participating in another interventional clinical trial.

9. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperglycemia

Intervention

Device:
• SMBG Meter
Self Monitoring Blood Glucose Meter
• FreeStyle Libre 2 System
The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System

Locations

Country	Name	City	State
United States	Billings Clinic	Billings	Montana
United States	Valley Research	Fresno	California
United States	Palm Research Center	Las Vegas	Nevada
United States	CEDE (Center of Excellence in Diabetes and Endocrinology)	Sacramento	California
United States	Metabolic Research Institute	West Palm Beach	Florida

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 in subjects with type 2 diabetes	To assess the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System on time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen when compared to the current standard of care (SMBG, self-monitoring of blood glucose).	Six (6) months