Intermittent CGM Use for Prediabetes

Overseen By Ambika Ashraf, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Chronic steroids

Disqualifiers: Type 1 diabetes, Type 2 diabetes, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if using a device that tracks blood sugar levels can help young people with pre-diabetes manage their condition better. The device gives real-time feedback on blood sugar levels. Researchers want to see if adding this device to standard care improves health outcomes for these youths. Monitoring blood sugar levels in real-time can help in managing diabetes more effectively.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must have a stable metformin dose for 1 month before joining or not be using metformin at all.

What data supports the effectiveness of the treatment Abbott Freestyle Libre 2 for prediabetes?

The FreeStyle Libre 2 system, used for continuous glucose monitoring, has shown benefits in managing blood sugar levels in people with type 1 and type 2 diabetes, which suggests it might help those with prediabetes by providing better glucose monitoring and potentially improving lifestyle changes. ^{1 2 3 4 5}

How does intermittent CGM use for prediabetes differ from other treatments?

Intermittent continuous glucose monitoring (CGM) for prediabetes is unique because it allows individuals to track their glucose levels without the need for constant monitoring, using a sensor that can be worn for up to 14 days. This approach provides insights into glucose patterns and helps in making lifestyle adjustments, unlike traditional methods that rely on less frequent blood sugar checks. ^{2 3 4 6 7}

Research Team

Jessica A Schmitt, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

I have been on a stable dose of metformin for at least 1 month or I don't use metformin.

My body has reached a moderate level of physical development.

My body shows moderate to full physical development.

Exclusion Criteria

I have or had cancer.

I have been diagnosed with diabetes.

I regularly use steroids for a long-term condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial assessments and baseline measurements including fasting labs and anthropomorphics

1 visit

1 visit (in-person)

Treatment

Participants receive standard medical care for prediabetes, with the experimental group using CGM intermittently for 2 weeks each month

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abbott Freestyle Libre 2

Trial Overview 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.

Participant Groups

Group I: CGM + Traditional Counseling Experimental Treatment 2 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

The Abbott FreeStyle Libre continuous glucose monitoring systems (CGM 1, CGM 2, and CGM 3) maintained their functionality and data integrity after exposure to X-ray, CT, and MRI simulations, indicating they are safe to wear during these diagnostic procedures.

The sensors experienced minimal displacement forces during MRI, well below the threshold needed to dislodge them, confirming that patients can safely continue using these sensors during imaging without risk of losing them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Functional Integrity of Continuous Glucose Monitoring Sensors When Used During Radiologic Procedures Under High Exposure Conditions. Matievich, W., Kiaie, N., Dunn, TC.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of the FreeStyle Libre system and diabetes treatment progression in T2DM: Results from a retrospective cohort study using a Canadian private payer claims database. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Functional Integrity of Continuous Glucose Monitoring Sensors When Used During Radiologic Procedures Under High Exposure Conditions. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Glycemic improvement with a novel interim intervention technique using retrospective professional continuous glucose monitoring (GLITTER study): A study from Mumbai, India. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A comparison of FreeStyle Libre 2 to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control: a 12-week randomised controlled trial protocol. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Accuracy of a flash glucose monitoring system in cats and determination of the time lag between blood glucose and interstitial glucose concentrations. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. [2018]

7. India pubmed.ncbi.nlm.nih.gov

Intermittent Use of Continuous Glucose Monitoring: A New Paradigm in Treatment of Type 2 Diabetes. [2023]