Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy

(CGM2 Trial)

Recruiting at 6 trial locations

Overseen By Ashley Battarbee, MD, MSCR

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Insulin, Hypoglycemics

Disqualifiers: Multiple gestation, Major fetal anomaly, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Up to 9 months

564 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have type 2 diabetes treated with daily insulin injections or oral hypoglycemic agents, so you may need to continue those treatments.

Is continuous glucose monitoring safe for use during pregnancy?

Continuous glucose monitoring (CGM) has been used in pregnancies with diabetes and is generally considered safe, with studies showing it is feasible without severe side effects. ^{1 2 3 4 5}

How is continuous glucose monitoring different from other treatments for type 2 diabetes in pregnancy?

Continuous glucose monitoring (CGM) is unique because it provides frequent, real-time glucose measurements, allowing for better detection of blood sugar trends and fluctuations compared to traditional finger stick tests. This can help improve glucose management and potentially lead to better outcomes for both mother and baby. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy?

Research shows that continuous glucose monitoring (CGM) helps improve pregnancy outcomes in women with diabetes by providing better control of blood sugar levels, which is important for the health of both the mother and baby. ^{1 3 4 6 9}

Who Is on the Research Team?

Ashley Battarbee, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with type 2 diabetes. They should be willing to monitor their blood sugar levels using either continuous glucose monitoring (CGM) or traditional fingerstick tests throughout pregnancy and provide blood samples.

Inclusion Criteria

I am a woman aged between 18 and 50.

I am pregnant and between 6 to less than 23 weeks along.

I have type 2 diabetes, use insulin or pills, and had an A1c of 6.5% or higher before or early in pregnancy.

Exclusion Criteria

Participating in another conflicting interventional study

Participation in this trial in a previous pregnancy

Multiple gestation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use continuous glucose monitoring or self-monitoring of blood glucose from enrollment until delivery, with regular blood draws and surveys at specified intervals

Up to 9 months

4 visits (in-person) at enrollment, 24 weeks, 34 weeks, and delivery; additional telehealth visits as needed

Follow-up

Participants are monitored for maternal and neonatal outcomes, including collection of umbilical cord blood and neonatal assessments

Up to 12 months post-delivery

What Are the Treatments Tested in This Trial?

Interventions

• CGM

Trial Overview The study compares the effectiveness of continuous glucose monitoring (CGM) versus self-monitoring of blood glucose in managing type 2 diabetes during pregnancy, focusing on both infant and maternal outcomes.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring Experimental Treatment 1 Intervention

Real-time continuous glucose monitoring

Group II: Self-Monitoring of Blood Glucose Active Control 1 Intervention

Self-monitoring of blood glucose (standard of care)

CGM is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Canada as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

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]

In a study involving 55 pregnant women with diabetes, the continuous glucose monitoring system (CGMS) provided valuable insights that altered clinical management decisions in 62% of cases, helping to identify previously undetected glucose fluctuations.

Patient feedback was largely positive, with 77% of respondents feeling that the benefits of using CGMS outweighed any inconvenience, indicating good tolerability and perceived usefulness in managing diabetes during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of continuous glucose monitoring in clinical decision-making in diabetes in pregnancy. McLachlan, K., Jenkins, A., O'Neal, D.[2009]

Continuous glucose monitoring (CGM) is feasible and safe for use during pregnancy in women with type 1 and type 2 diabetes, as shown by observational studies with no severe side effects reported.

A randomized controlled trial indicated that CGM leads to improved metabolic control and a reduced risk of macrosomia (large baby size), highlighting its potential benefits for pregnant women with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous glucose monitoring in pregnancies complicated by diabetes]. Madsen, AB., Secher, AL., Damm, P., et al.[2011]

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]

Continuous glucose monitoring (CGM) is becoming a recommended method for managing blood sugar levels in pregnant women with diabetes, as it is less invasive than traditional blood glucose measurements.

Optimal glycemic control during pregnancy is crucial for improving both maternal and neonatal outcomes, highlighting the importance of effective monitoring strategies like CGM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in Pregnancy. Horgan, R., Hage Diab, Y., Fishel Bartal, M., et al.[2023]

Citations

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

The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. [2022]

2. 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]

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

Continuous glucose monitoring for treatment adjustment in diabetic pregnancies--a pilot study. [2019]

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

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

5. Australia pubmed.ncbi.nlm.nih.gov

The role of continuous glucose monitoring in clinical decision-making in diabetes in pregnancy. [2009]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Continuous glucose monitoring in pregnancies complicated by diabetes]. [2011]

7. 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]

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

Continuous glucose monitoring in pregnancy: new frontiers in clinical applications and research. [2021]

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

Continuous Glucose Monitoring in Pregnancy. [2023]