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Continuous Glucose Monitoring

FreeStyle Libre System for Type 2 Diabetes

N/A
Waitlist Available
Research Sponsored by Abbott Diabetes Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject agrees to a 3-month period of no diabetes medication changes
Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three (3) months
Awards & highlights

Study Summary

This trial will compare the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application to see if the app can help reduce time spent with high blood sugar for people with type 2 diabetes who are not well controlled with their current medication.

Who is the study for?
This trial is for adults with type 2 diabetes who have high blood sugar levels despite taking certain oral medications. Participants need to own a smartphone, be willing to track their diet and lifestyle changes, and not change their diabetes medication during the study. Pregnant individuals, those on insulin or sulfonylurea drugs, or with allergies to medical adhesives/isopropyl alcohol cannot join.Check my eligibility
What is being tested?
The study compares two approaches: using the FreeStyle Libre Flash Glucose Monitoring System alone versus pairing it with a food logging app. The goal is to see which method better reduces periods of high blood sugar in people whose condition isn't well-controlled by oral meds.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the device's adhesive or allergic reactions for those sensitive to medical-grade adhesives or isopropyl alcohol used in skin disinfection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to change my diabetes medications for 3 months.
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I am currently taking medication for diabetes.
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I am 18 years old or older.
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I have been diagnosed with type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three (3) months
This trial's timeline: 3 weeks for screening, Varies for treatment, and three (3) months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Impact on time above 180 mg/dL

Trial Design

2Treatment groups
Active Control
Group I: FreeStyle LibreActive Control1 Intervention
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.
Group II: FreeStyle Libre plus food loggingActive Control1 Intervention
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.

Find a Location

Who is running the clinical trial?

Abbott Diabetes CareLead Sponsor
63 Previous Clinical Trials
24,419 Total Patients Enrolled
Shridhara A Karinka, PhDStudy DirectorAbbott Diabetes Care Inc
9 Previous Clinical Trials
2,441 Total Patients Enrolled

Media Library

FreeStyle Libre System (Continuous Glucose Monitoring) Clinical Trial Eligibility Overview. Trial Name: NCT04843527 — N/A
Type 2 Diabetes Research Study Groups: FreeStyle Libre, FreeStyle Libre plus food logging
Type 2 Diabetes Clinical Trial 2023: FreeStyle Libre System Highlights & Side Effects. Trial Name: NCT04843527 — N/A
FreeStyle Libre System (Continuous Glucose Monitoring) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04843527 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04843527 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many local establishments are conducting this research project?

"Boston Medical Center in Boston, Massachusetts, Henry Ford Health System in Detroit, Michigan and HealthPartners Institute dba International Diabetes Centre located at Minneapolis Minnesota are the primary sites; 4 other locations also have this trial running."

Answered by AI

Is this medical research program currently accepting new participants?

"According to the information obtained through clinicaltrials.gov, this trial is presently open for enrolment. It was initially posted on April 2nd 2021 and its most recent update occurred November 17th 2022."

Answered by AI

What is the total number of individuals participating in this experiment?

"This clinical trial necessitates 350 participants, satisfying the stipulated eligibility requirements. Potential volunteers can join from numerous sites such as Boston Medical Center in Massachusetts and Henry Ford Health System in Michigan."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
Henry Ford Health System
UMPC
HealthPartners Institute dba International Diabetes Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I’ve tried several medications and need help getting my blood sugars under control below 140.
PatientReceived 1 prior treatment
I actively manage my diabetes and am open to learning additional information on how to improve my management.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
2021. "Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04843527.
All > Diabetes Type 2
~9 spots leftby Jun 2024
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