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?

This trial examines whether continuous glucose monitoring (CGM), which uses a sensor to track blood sugar levels, is more effective than the usual fingerstick method for managing type 2 diabetes in pregnant women. Researchers aim to determine if this method improves outcomes for both mother and baby. They also explore factors that might increase the risk of complications during pregnancy. Women pregnant with a single baby, diagnosed with type 2 diabetes before or early in pregnancy, and currently using insulin or diabetes pills may be suitable candidates. Participants will track their blood sugar, have blood drawn periodically, and complete surveys about their experiences and stress levels. As an unphased trial, this study offers participants the chance to contribute to important 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. 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.

What prior data suggests that continuous glucose monitoring is safe for pregnant women with type 2 diabetes?

Research has shown that continuous glucose monitoring (CGM) is generally safe and can help manage blood sugar levels during pregnancy. Studies have found that CGM provides real-time information and alerts, which can prevent blood sugar from becoming too high or too low. This is crucial for the health of both the mother and the baby.

In some cases, CGM has been associated with fewer newborns being larger than expected and a reduced risk of low blood sugar in babies. While specific safety information for pregnant women with type 2 diabetes is still being gathered, CGM is already used in other diabetes treatments and is generally well-accepted.

Overall, CGM appears to be a promising tool for managing diabetes during pregnancy, though more research is needed to fully understand its safety and effectiveness for this group. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) for managing Type 2 diabetes in pregnancy because it offers real-time tracking of blood sugar levels. Unlike the traditional self-monitoring of blood glucose, which involves intermittent finger pricks, CGM provides a continuous stream of data, helping expectant mothers maintain stable glucose levels more effectively. This real-time feedback can lead to better management of diabetes, potentially improving health outcomes for both mother and baby.

What evidence suggests that continuous glucose monitoring is effective for type 2 diabetes in pregnancy?

This trial will compare Continuous Glucose Monitoring (CGM) with Self-Monitoring of Blood Glucose (standard of care) for managing type 2 diabetes in pregnancy. Research has shown that CGM can manage blood sugar levels more effectively than traditional fingerstick tests. CGM provides real-time data and alerts, leading to better long-term blood sugar control, as evidenced by lower hemoglobin A1c levels. Studies also suggest that CGM use is linked to fewer cases of babies being larger than average at birth, a common concern in pregnancies affected by diabetes. Additionally, CGM may reduce the risk of dangerous spikes and drops in blood sugar, which can harm both mother and baby. While more research is needed specifically for pregnancies with type 2 diabetes, these findings suggest that CGM could benefit both mothers and their babies. ^{1 2 6 7 8}

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

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11486575/

Continuous Glucose Monitoring for Diabetes Management ... Evidence for the role of CGM in pregnant people with T2D and GDM is currently lacking but clinical trials are underway or anticipated soon.

2. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-025-01854-x

Continuous glucose monitoring system in diabetes in pregnancy CGM provides real-time data and alerts, enabling early interventions that can mitigate both hypoglycemia and hyperglycemia, thereby reducing ...

3. ajog.org ajog.org/article/S0002-9378(25)00217-0/fulltext

Evidence for improved glucose metrics and perinatal ... Usage of continuous glucose monitoring (vs self-monitoring of blood glucose) reduces hemoglobin A1c and possibly large for gestational age across diabetes in ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521690X25000934

The role of continuous glucose monitoring in the diagnosis ... CGM shows potential for early detection of subclinical dysglycaemia, improved diagnostic accuracy when combined with clinical risk scores, and ...

5. diabetesjournals.org diabetesjournals.org/care/article/47/1/54/154012/Optimizing-Patient-Outcomes-in-Pregnancy-What

What Continuous Glucose Monitoring Metrics Should We Be ... In this trial, the use of CGM was associated with improvement in glycemic parameters and reduction in adverse neonatal outcomes (4).

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15999

Use of continuous glucose monitoring and hybrid closed‐loop ... Real-time CGM (rtCGM) continuously collects glucose data and transmits it every 5 min to a receiver, insulin pump, or smartphone application, ...

7. liebertpub.com liebertpub.com/doi/full/10.1089/dia.2023.0300

Continuous Glucose Monitoring Metrics in High-Risk ... The addition of real-time CGM in pregnancy has been shown to reduce neonatal hypoglycemia, large-for-gestational-age (LGA) infants, and neonatal ...

8. e-enm.org e-enm.org/journal/view.php?number=2424

The Benefits Of Continuous Glucose Monitoring In Pregnancy Consistent rt-CGM use has already shown positive effects on glycemic outcomes in type 2 diabetes patients taking basal-insulin-only, though that ...