Continuous Glucose Monitor Use in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2027-07-01

Brief Summary

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The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

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Detailed Description

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A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant women with T2DM, and significant potential to reduce the significant multigenerational effects associated with diabetes in pregnancy with this technology.

The study team therefore propose to perform a randomized controlled trial among 180 pregnant women with T2DM comparing CGM use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Conditions

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Type 2 Diabetes Treated With Insulin Pregnancy, High Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, single center, randomized study evaluating pregnancy glycemic monitoring strategies between women with continuous glucose monitors and standard of care fingerstick glucose monitoring.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Continuous Glucose Monitoring (CGM)

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 Type EXPERIMENTAL

Continuous Glucose Monitor

Intervention Type DEVICE

Continuous Glucose Monitor

Fingerstick Glucose Monitoring

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.

Group Type ACTIVE_COMPARATOR

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Intervention Type DEVICE

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Interventions

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Continuous Glucose Monitor

Intervention Type DEVICE

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\) age greater than or equal to 18 years old
* 2\) singleton gestation less than or equal to 14 weeks at initial obstetric visit
* 3\) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL
* 4\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
* 5\) able and willing to provide informed consent

Exclusion Criteria

* 1\) known diagnosis of type 1 diabetes or gestational diabetes
* 2\) plan to receive prenatal care or delivery outside of UMMHC
* 3\) inability to provide informed consent
* 4\) multifetal gestation

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No