What side effects are associated with this type of intervention?

The most common treatments for prediabetes include lifestyle interventions and pharmacologic treatments like metformin. Lifestyle changes, such as improved diet and increased physical activity, generally have minimal side effects but can sometimes lead to muscle soreness or fatigue. Metformin, a frequently used medication, may cause gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Continuous glucose monitoring (CGM), which is being studied for intermittent use, is generally well-tolerated but may cause skin irritation at the sensor site.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for the treatment of prediabetes in the provided context. However, the use of continuous glucose monitors (CGMs) is being evaluated for its potential benefits in improving metabolic health in youth with prediabetes. This suggests a growing interest in real-time glucose monitoring as a tool for managing prediabetes, although specific FDA-approved treatments for this condition are not detailed.

What other types of research exist?

Promising alternatives to intermittent use of CGMs for prediabetes patients include: 1) Pharmacologic therapy with metformin, which is suggested for patients with impaired fasting glucose or impaired glucose tolerance when lifestyle interventions are insufficient. 2) The use of semaglutide for individuals with overweight or obesity, which may help delay or prevent the onset of diabetes. 3) Telemedicine interventions, including teleconsultation and remote-patient monitoring, which have shown modest improvements in A1C levels. These alternatives offer different approaches to managing prediabetes, focusing on medication, lifestyle changes, and remote monitoring.

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Intermittent CGM Use for Prediabetes

N/A

Waitlist Available

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

Must not have

Current or history of malignancy

Diagnosis of type 1 diabetes, type 2 diabetes, other forms of diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had cancer.

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I have been diagnosed with diabetes.

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I regularly use steroids for a long-term condition.

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My BMI is below the 85th percentile for my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CGM Acceptability

Progression of prediabetes

Secondary study objectives

Glycemic metrics

Hyperlipidemia

Insulin sensitivity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prediabetes include lifestyle interventions and continuous glucose monitoring (CGM). Lifestyle interventions, such as dietary changes and increased physical activity, improve insulin sensitivity and lower blood glucose levels. CGM provides real-time feedback on glucose levels, enabling patients to make immediate adjustments to their diet and activity to prevent blood sugar spikes. These treatments are important for prediabetes patients as they help in early detection and management of blood glucose levels, potentially preventing the progression to type 2 diabetes.

Glucose time series complexity as a predictor of type 2 diabetes.The use of continuous glucose monitoring in patients with type 2 diabetes.