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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Dexcom G6 CGM for diabetes in pregnancy?

Research shows that continuous glucose monitoring (CGM) like the Dexcom G6 helps improve blood sugar control and pregnancy outcomes in women with diabetes, including reducing the risk of having larger babies and other complications compared to standard finger stick checks. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for pregnant women with diabetes?

The Dexcom G6 continuous glucose monitoring system is considered safe for pregnant women with diabetes, as studies show no device-related adverse events and only minor or no skin reactions at the sensor sites. ^{1 4 5 6 7}

How does the Dexcom G6 CGM treatment differ from standard checks for diabetes in pregnancy?

The Dexcom G6 CGM is a continuous glucose monitoring system that provides real-time glucose readings, allowing for more precise and timely management of blood sugar levels compared to standard finger-prick tests. This system is particularly beneficial during pregnancy as it helps improve maternal and neonatal outcomes by maintaining better glycemic control. ^{1 4 8 9 10}

Research Team

Jacquelyn H Adams, MD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. [2021]

5. Poland pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring parameters in pregnancy-related complications in patients with type 1 diabetes: a retrospective cohort study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring-derived glycemic metrics and adverse pregnancy outcomes among women with gestational diabetes: a prospective cohort study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Benefits of Real-Time Continuous Glucose Monitoring in Pregnancy. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Validation of the Continuous Glucose Monitoring System (CGMS) by the use of two CGMS simultaneously in pregnant women with type 1 diabetes mellitus. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The Continuous Glucose Monitoring System during pregnancy of women with type 1 diabetes mellitus: accuracy assessment. [2006]