What is the mechanism of action of this treatment?

The most common treatments for Type 2 Diabetes (T2DM) include insulin therapy and continuous glucose monitoring (CGM). Insulin therapy works by promoting glucose uptake in tissues and suppressing hepatic glucose production, thereby regulating blood glucose levels. CGM provides real-time glucose readings, enabling precise adjustments in insulin dosing and other treatments. This approach helps maintain optimal glycemic control, which is crucial for reducing the risk of complications such as cardiovascular disease, neuropathy, and retinopathy in T2DM patients.

What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include metformin, sulfonylureas, insulin, GLP-1 receptor agonists, and SGLT2 inhibitors. Metformin often causes gastrointestinal issues like nausea and diarrhea. Sulfonylureas can lead to hypoglycemia and weight gain. Insulin therapy may also cause hypoglycemia and weight gain. GLP-1 receptor agonists, such as liraglutide, can cause gastrointestinal side effects and have been associated with a lower risk of severe hypoglycemia. SGLT2 inhibitors may lead to urinary tract infections and genital infections. Continuous glucose monitoring helps manage these treatments by providing real-time glucose readings, which can reduce the risk of hypoglycemia and improve overall glycemic control.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Type 2 Diabetes that are often used in conjunction with Continuous Glucose Monitors (CGMs) for better blood sugar management. These include insulin therapies, such as long-acting insulin glargine, and GLP-1 receptor agonists like liraglutide and exenatide, which help improve glycemic control. Additionally, SGLT2 inhibitors, such as dapagliflozin, have been approved and are known for their efficacy in lowering blood glucose levels. These medications, when used alongside CGMs, can significantly enhance the management of Type 2 Diabetes by providing real-time glucose readings and enabling more precise adjustments to therapy.

What other types of research exist?

Promising alternatives to Continuous Glucose Monitors for Type 2 Diabetes patients in 2024 include: 1) Glucagon-like peptide-1 (GLP-1) receptor agonists such as semaglutide and tirzepatide, which have shown significant improvements in glycemic control. 2) Advanced insulin delivery systems like hybrid closed-loop (HCL) insulin pumps, which automatically adjust insulin delivery based on sensor glucose values. 3) Telemedicine interventions, including remote patient monitoring and teleconsultations, which have demonstrated modest reductions in A1C levels and improved diabetes management.

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Continuous Glucose Monitor

Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy

N/A

Waitlist Available

Led By Gianna L Wilkie, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

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

Must have

Singleton gestation less than or equal to 14 weeks at initial obstetric visit

Be older than 18 years old

Must not have

Known diagnosis of type 1 diabetes or gestational diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 minutes after delivery

Awards & highlights

Summary

This trial will compare the effects of a continuous glucose monitor vs standard care on pregnant women with type 2 diabetes mellitus and their infants.

Who is the study for?

This trial is for pregnant women over 18 with type 2 diabetes, less than 14 weeks into their pregnancy, and receiving care at UMASS Memorial Health Care. They must have a confirmed diagnosis of T2DM and be able to consent. Women with multiple pregnancies or planning care outside UMMHC, or those with type 1 or gestational diabetes cannot join.Check my eligibility

What is being tested?

The study compares the use of a continuous glucose monitor (CGM) versus routine fingerstick blood glucose monitoring in managing type 2 diabetes during pregnancy. It aims to see how each method affects baby's size at birth, mother's sugar control, satisfaction with treatment, and other pregnancy outcomes.See study design

What are the potential side effects?

While CGMs are generally safe, potential side effects include skin irritation from the sensor adhesive, inaccurate readings leading to mismanagement of glucose levels which could affect both mother and baby's health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant with one baby and less than 14 weeks along.

Exclusion Criteria

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

Select...

I have been diagnosed with type 1 or gestational diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at delivery

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Large for Gestational Age Infant

Secondary outcome measures

APGAR less than 7 at 5 minutes of life

Gestational age at delivery

Hypertensive Disorders of Pregnancy

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Continuous Glucose Monitoring (CGM)Experimental Treatment1 Intervention

Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery.

Group II: Fingerstick Glucose MonitoringActive Control1 Intervention

Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitor

2021

Completed Early Phase 1

~860

0 / 2Eligibility 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

The most common treatments for Type 2 Diabetes (T2DM) include insulin therapy and continuous glucose monitoring (CGM). Insulin therapy works by promoting glucose uptake in tissues and suppressing hepatic glucose production, thereby regulating blood glucose levels. CGM provides real-time glucose readings, enabling precise adjustments in insulin dosing and other treatments. This approach helps maintain optimal glycemic control, which is crucial for reducing the risk of complications such as cardiovascular disease, neuropathy, and retinopathy in T2DM patients.

Assessing the quality of the evidence underlying recommendations in type 2 diabetes' commonly used clinical practice guidelines.Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial.