What side effects are associated with this type of intervention?

Common treatments for insulin resistance include lifestyle interventions, metformin, thiazolidinediones, and continuous glucose monitoring (CGM). Metformin is generally well-tolerated but can cause gastrointestinal side effects such as nausea and diarrhea. Thiazolidinediones, like rosiglitazone, may lead to weight gain, edema, and an increased risk of fractures. CGM, particularly when combined with sensor-augmented pump therapy with a predictive low glucose suspend feature, has shown promise in preventing hypoglycemia. However, CGM devices can sometimes cause skin irritation at the sensor site and may require frequent calibration.

What prior FDA approvals exist?

FDA-approved treatments for insulin resistance include metformin, which is often the first-line therapy, and GLP-1 receptor agonists like liraglutide and exenatide. These drugs help improve glycemic control and are sometimes used in conjunction with continuous glucose monitoring (CGM) systems. CGM technologies, such as sensor-augmented pump therapy with predictive low glucose suspend features, have shown promise in preventing hypoglycemia and improving overall glycemic management. While CGM itself is not a treatment for insulin resistance, it plays a crucial role in monitoring and optimizing the effectiveness of these pharmacologic therapies.

What other types of research exist?

Promising novel alternatives to Continuous Glucose Monitoring (CGM) for insulin resistance patients in 2024 include: 1) Non-invasive glucose monitoring devices that use optical sensors to measure glucose levels through the skin, 2) Advanced wearable biosensors that continuously monitor multiple biomarkers related to glucose metabolism, 3) Artificial Intelligence (AI)-driven predictive analytics platforms that use data from various health metrics to provide personalized glycemic control recommendations, and 4) New classes of medications such as GLP-1 receptor agonists and SGLT-2 inhibitors, which have shown efficacy in improving glycemic control and reducing insulin resistance.

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Continuous Glucose Monitoring for Polycystic Ovary Syndrome (GEMS-PCOS Trial)

N/A

Recruiting

Led By Heather G Huddleston, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a wearable device to monitor blood sugar levels in women with PCOS. The goal is to see if continuous monitoring can help manage their blood sugar and improve their overall health. The study will compare results from those using the device to those who do not. These devices were primarily developed for individuals with diabetes but are now being used by people without diabetes for various health applications.

Who is the study for?

This trial is for women aged 18-45 who may have Polycystic Ovary Syndrome (PCOS) as defined by the Rotterdam criteria. Participants must agree to wear a Continuous Glucose Monitor (CGM) for 10 days and have a smartphone to monitor it. They can't join if they're on diabetes medication, have type I or II diabetes, or have used a CGM before.

What is being tested?

The study is testing how well the DEXCOM Continuous Glucose Monitor works in tracking blood sugar levels in real-world conditions for those with PCOS. It aims to understand glycemic patterns and see if using the CGM can improve metabolic and reproductive health.

What are the potential side effects?

While wearing a CGM typically has minimal side effects, some individuals might experience skin irritation at the site of attachment or discomfort from wearing the device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Difference between change in hemoglobin A1C

Secondary study objectives

Difference between change in fasting insulin

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: Intervention arm - CGMExperimental Treatment1 Intervention

Participants randomized to intervention arm will be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status AND will be asked to wear a DEXCOM CGM for 90 days.

Group II: Control armActive Control1 Intervention

Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status.

Do I qualify?Apply below to find out

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 insulin resistance include lifestyle interventions (diet and exercise), metformin, and continuous glucose monitoring (CGM). Lifestyle interventions improve insulin sensitivity by reducing body fat and increasing muscle glucose uptake. Metformin decreases hepatic glucose production and increases peripheral glucose uptake. CGM provides real-time data on glucose levels, allowing for timely adjustments in diet, exercise, and medication, which can improve glycemic control. These treatments are crucial for insulin resistance patients as they help manage blood glucose levels, reduce the risk of developing type 2 diabetes, and prevent complications associated with poor glycemic control.

Glucose time series complexity as a predictor of type 2 diabetes.Systematic review of randomized controlled trials to regulate glycaemia after stroke.The use of continuous glucose monitoring in patients with type 2 diabetes.