What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include continuous glucose monitoring (CGM), standard glucose checks, metformin, sulphonylureas, insulin, and incretin-based agents (DPP-4 inhibitors and GLP-1 analogues). CGM can cause skin irritation at the sensor site. Metformin is generally well-tolerated but can cause gastrointestinal issues like diarrhea and nausea. Sulphonylureas may lead to hypoglycemia and weight gain. Insulin therapy can also cause hypoglycemia and weight gain, along with injection site reactions. Incretin-based agents may cause gastrointestinal symptoms and have an uncertain long-term impact on beta-cell function.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes, including continuous glucose monitoring systems that allow real-time tracking of glucose levels. Additionally, drugs such as GLP-1 receptor agonists (e.g., exenatide and dulaglutide) have been approved for their efficacy in improving glycemic control. Exenatide, available in both extended-release (Bydureon BCise) and shorter-acting formulations (Byetta), and dulaglutide have shown significant improvements in glycemic control in clinical trials. These treatments, along with continuous glucose monitoring, provide comprehensive management options for patients with Type 2 Diabetes.

What other types of research exist?

Promising novel alternatives to Continuous Glucose Monitoring for Type 2 Diabetes patients include: 1) Telemedicine combined with remote patient monitoring, which has shown modest reductions in A1C levels and improved management through virtual care. 2) Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitors, which not only help in glycemic control but also offer cardiovascular and renal benefits. 3) Glucagon-Like Peptide-1 (GLP-1) receptor agonists, which improve glucose control and have favorable cardiovascular outcomes. These alternatives provide effective glucose management and additional health benefits.

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Continuous Glucose Monitoring

Continuous Glucose Monitoring vs Standard Checks for Diabetes in Pregnancy

N/A

Waitlist Available

Led By Jacquelyn H Adams, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

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

Must have

Age greater than or equal to 18 years of age at enrollment

Gestational age less than or equal to 19 weeks 6 days at enrollment

Must not have

Chronic use of medications known to cause hyperglycemia, such as HIV antiretrovirals and inhaled, injectable and oral corticosteroids

Use of concentrated insulin at enrollment (ie U500)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares continuous glucose monitoring with standard glucose checks in pregnant women with Type 2 Diabetes. It aims to see if continuous monitoring can better manage blood sugar levels and improve patient satisfaction.

Who is the study for?

The AT GOAL trial is for pregnant individuals over 18 with Type 2 Diabetes, not beyond their 19th week of pregnancy. They must understand English and have a single baby pregnancy. Those using concentrated insulin, preexisting CGM devices, or medications causing high blood sugar can't join.

What is being tested?

This study compares two methods of monitoring blood sugar in pregnant patients with Type 2 Diabetes: traditional finger stick checks versus the Dexcom G6 continuous glucose monitor (CGM). Participants will be observed for about six months to see which method they prefer and how well each controls glucose levels.

What are the potential side effects?

Potential side effects may include skin irritation from CGM sensor adhesives or discomfort from frequent finger sticks. Continuous monitoring might also cause anxiety due to constant awareness of glucose levels.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am less than 20 weeks pregnant.

Exclusion Criteria

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

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I regularly take medication that can increase my blood sugar, like steroids or HIV drugs.

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I am using a high-strength insulin (U500) at the moment.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences with Diabetes Management

Feasibility: Number of Participants Who Complete the Study within 24 month time period

Percentage of Time Where Blood Glucose is between 70-140 milligrams per deciliter (mg/dL)

Secondary study objectives

Percentage of time spent in hyperglycemic range

Percentage of time spent in hypoglycemic range

Qualitative Outcome: Interviews to understand Participant Sense of Control around Glucose Monitoring

+8 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: Arm 1: Continuous Glucose Monitor (CGM)Experimental Treatment1 Intervention

CGM for duration of pregnancy.

Group II: Arm 2: Point of Care Glucose Testing (POCT)Active Control2 Interventions

Point of care finger sticks for glucose monitoring. At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexcom G6 CGM

2023

N/A

~380

0 / 5Eligibility 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 Type 2 Diabetes (T2D) include insulin therapy, incretin-based therapies, and lifestyle interventions. Insulin therapy helps to lower blood glucose levels by facilitating the uptake of glucose into cells. Incretin-based therapies, such as GLP-1 receptor agonists and DPP-4 inhibitors, enhance insulin secretion and inhibit glucagon release, improving blood glucose control and promoting weight loss. Lifestyle interventions, including diet and exercise, improve insulin sensitivity and glycemic control. Continuous glucose monitoring (CGM) is crucial for T2D patients as it provides real-time tracking of glucose levels, allowing for timely adjustments in therapy and better overall management of the condition.

Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.Combination therapy for the improvement of long-term macrovascular and microvascular outcomes in type 2 diabetes: Rationale and evidence for early initiation.DPP-4 inhibitors and GLP-1 analogues: for whom? Which place for incretins in the management of type 2 diabetic patients?