Continuous Glucose Monitoring vs Standard Checks for Diabetes in Pregnancy

Overseen By Erin Bailey, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Concentrated insulin, HIV antiretrovirals

Disqualifiers: Multiple gestations, Preexisting CGM, others

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

Compensation: Varies

Number of Visits: 5

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two methods of monitoring blood sugar levels work for pregnant women with Type 2 Diabetes. One group will use a continuous glucose monitor (CGM), specifically the Dexcom G6 CGM, which tracks sugar levels throughout the day. The other group will use standard finger-stick tests. The researchers aim to determine which method better manages blood sugar and is preferred by participants. This trial suits women who are less than 20 weeks pregnant with Type 2 Diabetes and expecting one baby. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance diabetes management during pregnancy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using concentrated insulin or medications that cause high blood sugar, like certain HIV drugs and steroids.

What prior data suggests that continuous glucose monitoring is safe for pregnant patients with Type 2 Diabetes?

Research has shown that the Dexcom G6 Continuous Glucose Monitor (CGM) is accurate and safe for pregnant women with diabetes. Studies have found that this device helps manage blood sugar by detecting high and low levels, allowing for quick treatment changes to keep both mother and baby healthy.

The Dexcom G6 has performed well in other studies without causing major side effects. It helps maintain healthy blood sugar levels and prevents spikes or drops, which is crucial during pregnancy.

Overall, the Dexcom G6 CGM is well-tolerated and considered safe for pregnant women with diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing Continuous Glucose Monitoring (CGM) with standard point-of-care glucose testing for diabetes in pregnancy because CGM offers real-time glucose tracking. Unlike traditional fingerstick methods that provide only snapshots of glucose levels, the Dexcom G6 CGM continuously monitors and displays glucose trends, which can lead to better glucose management and potentially improved outcomes for both mother and baby. This continuous data can help in making more informed decisions about diet and insulin use throughout the day, enhancing the ability to maintain stable glucose levels.

What evidence suggests that continuous glucose monitoring is effective for managing diabetes in pregnancy?

Research shows that the Dexcom G6 Continuous Glucose Monitor (CGM), which participants in this trial may use, can help manage blood sugar levels during pregnancy. Studies have found that CGM can detect high and low blood sugar, allowing for quick adjustments. For pregnant individuals with diabetes, using CGM has resulted in more stable blood sugar levels compared to traditional finger-prick tests. In this trial, some participants will use the Dexcom G6 CGM, while others will use standard point-of-care finger stick glucose monitoring. One study found that CGM users spent more time with their blood sugar in the target range, benefiting both mother and baby. The Dexcom G6 is also known for its accuracy, especially when worn on the upper arm. ^{1 2 3 4 5}

Who Is on the Research Team?

Jacquelyn H Adams, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are pregnant with only one baby.

I was diagnosed with Type 2 Diabetes less than 20 weeks ago.

I am less than 20 weeks pregnant.

Exclusion Criteria

You already have a continuous glucose monitor (CGM) in place.

You are pregnant with more than one baby.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomized to either continuous glucose monitoring or standard glucose checks for the duration of pregnancy

26 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum interviews and surveys

2-6 weeks postpartum

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom G6 CGM
• Participant Finger Stick Glucose Monitoring

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm 1: Continuous Glucose Monitor (CGM) Experimental Treatment 1 Intervention

CGM for duration of pregnancy.

Group II: Arm 2: Point of Care Glucose Testing (POCT) Active Control 2 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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

In a study of 1302 pregnant women with gestational diabetes mellitus (GDM), continuous glucose monitoring (CGM) metrics were found to be associated with an increased risk of adverse pregnancy outcomes, such as preterm birth and NICU admission, indicating the importance of glucose control during pregnancy.

Specific CGM-derived thresholds, such as a time above range (TAR) of 2.5% and a daily mean blood glucose (MBG) of 4.8 mmol/L, could help identify women at higher risk for complications, suggesting that these metrics may be useful targets for interventions to improve pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring-derived glycemic metrics and adverse pregnancy outcomes among women with gestational diabetes: a prospective cohort study. Liang, X., Fu, Y., Lu, S., et al.[2023]

In a study of 115 pregnant women with diabetes, higher mean glucose levels in the second trimester were linked to an increased risk of having large for gestational age (LGA) babies, particularly in those with type 1 diabetes.

The area under the curve for glucose levels above the target range was significantly associated with LGA in type 2 diabetes and insulin-treated gestational diabetes, but no CGM metrics were found to correlate with other adverse outcomes like neonatal hypoglycemia or preterm birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial. Rademaker, D., van der Wel, AWT., van Eekelen, R., et al.[2023]

In a study of 117 pregnant patients with type 1 or 2 diabetes, continuous glucose monitoring (CGM) metrics were linked to neonatal outcomes, showing that higher time in range (TIR) significantly reduces the odds of neonatal morbidity by 28% for every 5 percentage-point increase in TIR.

The optimal TIR for improving neonatal outcomes was found to be between 66-71%, supporting the American Diabetes Association's recommendation of aiming for at least 70% TIR during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes. Sanusi, AA., Xue, Y., McIlwraith, C., et al.[2023]

The Dexcom G6 continuous glucose monitoring system demonstrated high accuracy in pregnant women with diabetes, with 92.5% of CGM values falling within ±20% of reference blood glucose values, indicating reliable performance across different sensor wear sites.

The study found no significant device-related adverse events, and skin reactions at insertion sites were either absent or minor, highlighting the safety of the Dexcom G6 system for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Castorino, K., Polsky, S., O'Malley, G., et al.[2021]

The Continuous Glucose Monitoring System (CGMS) demonstrated a high accuracy in reflecting glucose levels in pregnant women with type 1 diabetes, with a correlation coefficient of 0.94 based on 239 analyzed blood glucose values.

An impressive 93.8% of the non-calibration glucose readings fell within the clinically acceptable range according to the Clarke error grid analysis, indicating that CGMS can be a reliable tool for monitoring glucose in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Continuous Glucose Monitoring System during pregnancy of women with type 1 diabetes mellitus: accuracy assessment. Kerssen, A., de Valk, HW., Visser, GH.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757524/

Performance of the Dexcom G6 Continuous Glucose ... The advantages of CGM over SMBG testing alone have been demonstrated in RCTs showing that CGM contributes to improved maternal and neonatal outcomes in T1D.

2. diabetesjournals.org diabetesjournals.org/care/article/48/9/1581/163057/Real-Time-Continuous-Glucose-Monitoring-in

Real-Time Continuous Glucose Monitoring in Pregnancies ... We demonstrated a significantly higher %TIR using real-time CGM compared with CBG glucose monitoring among pregnant people with GDM. Studies are ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12335106/

Continuous glucose monitoring system in diabetes ... The overall MARD for Dexcom G6 compared with YSI was 10.3%, with even higher accuracy when the sensor was worn on the posterior upper arm (8.7%) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03981328

NCT03981328 | Real-time Continuous Glucose Monitoring ... The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The ...

5. drc.bmj.com drc.bmj.com/content/12/3/e003989

Glucose levels measured with continuous ... Results Participants wore CGM for a median of 123 days each. Glucose levels were nearly stable throughout all three trimesters in uncomplicated ...