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Intermittent CGM Use for Prediabetes

N/A
Recruiting
Led By Jessica A Schmitt, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
tanner stage 3 or above
Tanner stage 3 or above
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing if using a continuous glucose monitor, in addition to standard counseling for diet and exercise, can help improve the metabolic health of youth with pre-diabetes.

Who is the study for?
This trial is for English-speaking youth aged 14 or older with prediabetes, indicated by an A1c level of 5.7-6.4%. Participants should be at a Tanner stage 3 or above and have a BMI in the 85th percentile or higher for their age. They must not use chronic steroids, have any type of diabetes other than prediabetes, or have a current or past cancer diagnosis.Check my eligibility
What is being tested?
The study tests if using the Abbott Freestyle Libre 2 CGM intermittently, along with standard advice on diet and exercise, helps improve metabolic health in young people with prediabetes compared to just counseling alone.See study design
What are the potential side effects?
While there may not be direct side effects from using the CGM device itself, skin irritation can occur at the sensor's site. Standard physical activity and nutritional counseling are unlikely to cause side effects but could include muscle soreness from new exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body has reached a moderate level of physical development.
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My body shows moderate to full physical development.
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I am 14 years old or older.
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My BMI is in the top 85% for my age group.
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My metformin dose has been the same for the last month or I don't take metformin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
CGM Acceptability
Progression of prediabetes
Secondary outcome measures
Glycemic metrics
Hyperlipidemia
Insulin sensitivity
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CGM + Traditional CounselingExperimental Treatment2 Interventions
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
Group II: ControlActive Control1 Intervention
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,321 Total Patients Enrolled
Jessica A Schmitt, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Abbott Freestyle Libre 2 Clinical Trial Eligibility Overview. Trial Name: NCT05505565 — N/A
Prediabetes Research Study Groups: CGM + Traditional Counseling, Control
Prediabetes Clinical Trial 2023: Abbott Freestyle Libre 2 Highlights & Side Effects. Trial Name: NCT05505565 — N/A
Abbott Freestyle Libre 2 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505565 — N/A
Prediabetes Patient Testimony for trial: Trial Name: NCT05505565 — N/A

Frequently Asked Questions

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

What results are investigators hoping to achieve with this research?

"The main outcome of this trial, assessed over a 6 month period, is CGM Acceptability. Additionally, the researchers will be evaluating Transaminitis (AST and ALT), Hyperlipidemia (LDL/triglyceride/HDL/total cholesterol measurements) and Glycemic metrics (CGM data including: time in target range, time above target range and post-prandial glucose excursion)."

Answered by AI

Are there any vacancies open for participation in this trial?

"Clinicaltrials.gov suggests that this particular trial is not presently enrolling patients; the initial posting was on January 15, 2023 and has since been updated on November 7th 2022. While enrollment for this specific study is closed, a total of 1256 other studies are recruiting right now."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
North Dakota
Alabama
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
What site did they apply to?
Children's of Alabama

Why did patients apply to this trial?

Have tried no medications for pre-diabetes. I want to keep my blood glucose levels within normal range, get my aic levels down to normal and weight down.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes
Jessica Schmitt 2023. "Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05505565.
All > Prediabetes
~5 spots leftby Jun 2024
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