Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy

Recruiting in Palo Alto (17 mi)

Overseen by Gianna L Wilkie, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Type 1 diabetes, Gestational diabetes, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to compare the use of a Continuous Glucose Monitor (CGM) to traditional fingerstick tests in pregnant women with type 2 diabetes. The CGM continuously tracks blood sugar levels, providing real-time data to help manage diabetes more effectively. The study will evaluate its impact on infant size, maternal blood sugar control, and overall patient satisfaction.

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

Research shows that continuous glucose monitoring (CGM) can improve blood sugar control and pregnancy outcomes in women with diabetes, including type 1 diabetes. This suggests that CGM might also be beneficial for managing type 2 diabetes during pregnancy by helping to maintain better glucose levels, which is important for the health of both mother and baby.

^{1 2 3 4 5}

Is continuous glucose monitoring safe for pregnant women with type 2 diabetes?

Continuous glucose monitoring (CGM) is generally safe for pregnant women with diabetes, as studies show it can be used without severe side effects and helps manage blood sugar levels effectively.

^{3 4 6 7 8}

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

Continuous glucose monitoring (CGM) is unique because it provides real-time tracking of blood sugar levels throughout the day and night, allowing for more precise management of glucose levels compared to traditional methods like self-monitoring blood glucose (SMBG). This continuous data can help improve outcomes for both the mother and baby by optimizing glucose control during pregnancy.

^{2 3 4 8 9}

Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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, Australia 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

🇦🇺 Approved in Australia as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Massachusetts Memorial Medical Center Worcester, MA

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester Lead Sponsor

References

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

Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes. [2023] Continuous glucose monitoring (CGM) improves maternal glycemic control and neonatal outcomes in type 1 diabetes pregnancies compared with self-monitoring of blood glucose. However, CGM targets for pregnancy are based on expert opinion. We aimed to evaluate the association between CGM metrics and perinatal outcomes and identify evidence-based targets to reduce morbidity.

2. Australia pubmed.ncbi.nlm.nih.gov

The role of continuous glucose monitoring in clinical decision-making in diabetes in pregnancy. [2009] The continuous glucose monitoring system (CGMS) is a novel tool to assess 24-h glucose fluctuations. In pregnancies complicated by diabetes, where excellent glucose control is desired to improve maternal and fetal outcomes, CGMS may have a role in fine-tuning management.

3. China pubmed.ncbi.nlm.nih.gov

[Clinical use of continuous glucose monitoring system in gestational diabetes mellitus and type 2 diabetes complicated with pregnancy]. [2022] To compare the clinical use of continuous glucose monitoring system (CGMS) and self-monitoring blood glucose (SMBG) when monitoring blood glucose level of patients with gestational diabetes mellitus (GDM) or type 2 diabetes mellitus (DM) complicated with pregnancy.

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] The Continuous Glucose Monitoring System (CGMS, Medtronic MiniMed, Northridge, CA) allows close monitoring of glucose patterns and might be helpful in explaining the persistence of high complication rates in pregnancies of women with type 1 diabetes. It was the aim of this study to determine whether the CGMS accurately reflects glucose levels in pregnant women with type 1 diabetes mellitus.

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

The efficacy and effectiveness of continuous glucose monitoring during pregnancy: a systematic review. [2018] Diabetic pregnancies carry a high risk for both mother and child, especially when glycemic control is poor. A novel technique that aims to improve glycemic control is the continuous glucose monitor (CGM). This tool is already in use to improve pregnancy outcome. This review presents the available evidence on the efficacy of CGM use in pregnancy and the effectiveness on pregnancy outcome.

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

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023] Adverse events for continuous glucose monitors (CGMs) represent a significant issue for people with diabetes with 281 963 CGM adverse events occurring in 2022. The process to obtain adverse events and the US Food and Drug Administration (FDA) database that contains them are reviewed.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Progress and indication for use of continuous glucose monitoring in patients with diabetes in pregnancy: a review. [2023] Gestational diabetes mellitus is one of the most common endocrine diseases that occur during pregnancy. Disorders of blood glucose metabolism during pregnancy can increase the risk of adverse pregnancy outcomes, such as pregnancy-related hypertension, preeclampsia, eclampsia, miscarriage, macrosomia, and neonatal hypoglycemia. Continuous glucose monitoring (CGM) can safely and effectively monitor blood glucose changes in patients with gestational hyperglycemia, thereby reducing adverse pregnancy outcomes. Hence, this article aimed to provide a comprehensive review of the progress and indications for using CGM in pregnant patients with diabetes. CGM can reduce blood glucose fluctuations and the occurrence of serious hypoglycemia and hyperglycemia events and can provide time in range (TIR). TIR is an important indicator of blood glucose level. Patients with a higher TIR during pregnancy have better gestational outcomes.

8. Denmark pubmed.ncbi.nlm.nih.gov

[Continuous glucose monitoring in pregnancies complicated by diabetes]. [2011] In this review the use of continuous glucose monitoring (CGM) in pregnancy complicated by type 1 and type 2 diabetes is examined. Fourteen relevant articles were identified. Observational studies demonstrated that CGM was feasible during pregnancy without severe side effects. One randomised controlled trial resulted in improved metabolic control and reduced risk of macrosomia in women randomised to CGM. Future studies on the use of CGM in pregnancy are awaited with interest.

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

Time in Range in Pregnancy: Is There a Role? [2022] Continuous glucose monitoring (CGM) is being used with increasing frequency as an adjunct to self-monitoring of blood glucose in pregnancy, and novel targets based on CGM data are becoming standardized. This adoption of CGM is the result of its improving accuracy, patient preference, and evolving data demonstrating associations of novel targets such as time in range (TIR) with pregnancy and neonatal outcomes. A greater understanding of the relationship of various CGM metrics to outcomes in pregnancy complicated by diabetes is needed. It is clear that TIR parameters need to be uniquely lower for pregnant women than for nonpregnant individuals. CGM technology is also an integral part of hybrid closed-loop insulin delivery systems. These insulin delivery systems will be a significant advance in the management of diabetes during pregnancy if they can achieve the pre- and postprandial targets required for pregnancy and optimize TIR.