Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy

Overseen By Heidi Leftwich, DO

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Type 1 diabetes, Gestational diabetes, 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: Unknown

Duration: Until delivery

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a continuous glucose monitor (CGM) is more effective than regular fingerstick tests for pregnant women with type 2 diabetes. Researchers aim to determine which method better controls blood sugar, results in healthier babies, and increases maternal satisfaction with care. Women who are less than 14 weeks pregnant with type 2 diabetes and are receiving care at UMASS Memorial Health Care may qualify for this study. As an unphased trial, it offers participants the chance to contribute to important research that could enhance diabetes care for pregnant women.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

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

Research has shown that continuous glucose monitors (CGMs) are generally safe for pregnant women with type 2 diabetes. These devices do not cause more side effects than the usual fingerstick tests. CGMs, in fact, help monitor blood sugar levels more closely, which is crucial for managing diabetes during pregnancy.

Some studies have found that regular use of CGMs can improve blood sugar control. Specifically, women who kept their blood sugar within the recommended range experienced better pregnancy outcomes. However, in some instances, CGM users had less "time in range," meaning their blood sugar levels were not always ideal. This did not increase risks compared to traditional methods, but it is something to consider.

Overall, CGMs are considered safe and well-tolerated for pregnant women with type 2 diabetes, providing a useful tool to manage blood sugar levels effectively. ^{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 insights into blood sugar levels, unlike traditional fingerstick glucose monitoring, which provides only periodic snapshots. CGM uses a sensor that continuously tracks glucose levels and transmits this data to a smartphone or reader, allowing for more precise and timely adjustments to diet and insulin. This continuous data stream can help expectant mothers maintain better glucose control, potentially reducing risks for both mother and baby.

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

Research has shown that continuous glucose monitoring (CGM), which participants in this trial may receive, can help pregnant women with type 2 diabetes maintain more stable blood sugar levels. In a study of 65 pregnant women, those who used CGM achieved better blood sugar control. Another study found that CGM use was linked to better health outcomes, with fewer complications for both mother and baby. This monitoring method provides real-time information, allowing for quicker adjustments to maintain healthy blood sugar levels. Overall, continuous glucose monitoring appears to offer better support for managing diabetes during pregnancy compared to traditional fingerstick methods, another approach under study in this trial. ^{1 2 3 5 6}

Who Is on the Research Team?

Gianna L Wilkie, MD

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with type 2 diabetes, less than 14 weeks into their pregnancy, and receiving care at UMASS Memorial Health Care. They must have a confirmed diagnosis of T2DM and be able to consent. Women with multiple pregnancies or planning care outside UMMHC, or those with type 1 or gestational diabetes cannot join.

Inclusion Criteria

Able and willing to provide informed consent

Receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC

I am pregnant with one baby and less than 14 weeks along.

Exclusion Criteria

I have been diagnosed with type 1 or gestational diabetes.

Plan to receive prenatal care or delivery outside of UMMHC

You are pregnant with more than one baby.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either continuous glucose monitoring (CGM) or standard fingerstick glucose monitoring for the duration of pregnancy until delivery

Until delivery

Follow-up

Participants are monitored for safety and effectiveness after delivery, including assessments of maternal and neonatal outcomes

Postpartum day 1

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor
• Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Trial Overview The study compares the use of a continuous glucose monitor (CGM) versus routine fingerstick blood glucose monitoring in managing type 2 diabetes during pregnancy. It aims to see how each method affects baby's size at birth, mother's sugar control, satisfaction with treatment, and other pregnancy outcomes.

How Is the Trial Designed?

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

Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery.

Group II: Fingerstick Glucose Monitoring Active Control 1 Intervention

Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic.

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

Approved in United States as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes
• Insulin-treated Diabetes

Approved in European Union as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes
• Gestational Diabetes

Approved in Canada as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Approved in Japan as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

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]

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 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

Continuous glucose monitoring system (CGMS) is more effective than self-monitoring blood glucose (SMBG) in detecting postprandial hyperglycemia and nocturnal hypoglycemia in pregnant patients with diabetes, as shown in a study of 99 patients over a 72-hour monitoring period.

Both CGMS and SMBG accurately reflect blood glucose levels, but controlling blood glucose is more challenging in patients with type 2 diabetes complicated by pregnancy compared to those with gestational diabetes mellitus (GDM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical use of continuous glucose monitoring system in gestational diabetes mellitus and type 2 diabetes complicated with pregnancy]. Song, Y., Yang, H.[2022]

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 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 use of continuous glucose monitors (CGM) in pregnancy shows mixed results; one small randomized controlled trial (RCT) indicated that retrospective CGM significantly reduced third-trimester HbA1c levels and neonatal macrosomia, while another RCT on real-time CGM found no impact on glycemic control or pregnancy outcomes.

Overall, the current evidence is limited and contradictory, highlighting the need for more comprehensive RCTs to assess the effectiveness and cost-effectiveness of CGM in improving pregnancy outcomes before it can be widely adopted in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and effectiveness of continuous glucose monitoring during pregnancy: a systematic review. Voormolen, DN., DeVries, JH., Evers, IM., et al.[2018]

Continuous glucose monitoring (CGM) is increasingly used in pregnancy to improve blood glucose management, with a focus on novel targets like time in range (TIR) that are linked to better pregnancy and neonatal outcomes.

Pregnant women require different TIR parameters compared to nonpregnant individuals, and integrating CGM with hybrid closed-loop insulin delivery systems could significantly enhance diabetes management during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time in Range in Pregnancy: Is There a Role? Wyckoff, JA., Brown, FM.[2022]

Continuous glucose monitoring (CGM) is a safe and effective method for tracking blood glucose levels in pregnant women with gestational diabetes, helping to reduce the risk of serious complications such as hypertension and neonatal hypoglycemia.

Using CGM can lead to improved blood glucose control, as indicated by increased time in range (TIR), which is associated with better pregnancy outcomes for both the mother and the baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress and indication for use of continuous glucose monitoring in patients with diabetes in pregnancy: a review. Song, Y., Zhai, X., Bai, Y., et al.[2023]

Citations

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

Continuous glucose monitoring system in diabetes ... A retrospective cohort study evaluating 65 pregnant women with T2D and GDM found that both isCGM and rtCGM improved glycemic control. However, ...

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

Real-Time Continuous Glucose Monitoring in Pregnancies ... Continuous glucose monitoring and time in range: association with adverse outcomes among people with type 2 or gestational diabetes mellitus.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002937825002170

Evidence for improved glucose metrics and perinatal ... Within diabetes in pregnancy, continuous glucose monitoring use (vs self-monitoring of blood glucose) showed similar but stronger benefits in both type 1 ...

4. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(25)00063-4/fulltext

Continuous glucose monitoring in the management of ... Our results show that the outcome in individuals with gestational diabetes is not improved by the use of rtCGM. However, individuals expressed a ...

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

Continuous Glucose Monitoring Metrics in High-Risk ... Conclusion: In this high-risk group of women with T2DM, CGM metrics only improved during pregnancy in those with greater sensor use and were ...

6. ajog.org ajog.org/article/S0002-9378(22)01433-8/fulltext

Adverse pregnancy outcomes in people with Type 2 ... Among people with T2DM or GDM who utilized CGM during pregnancy, 4 out 10 individuals had TIR < 70% and they are at significantly higher risk of adverse ...