Continuous Glucose Monitor Use in Pregnancy

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Type 2 Diabetes Treated With Insulin; Pregnancy, High Risk

Treatments: Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose); Device: Continuous Glucose Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05317585

STUDY00001802

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Women will be deemed eligible for the study by the following 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: Women will be deemed ineligible for the study based on the following 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Continuous Glucose Monitoring (CGM)

Experimental group

Description:

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.

Treatment:

Device: Continuous Glucose Monitor

Fingerstick Glucose Monitoring

Active Comparator group

Description:

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.

Treatment:

Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)