Continuous Glucose Monitor Use in Pregnancy

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes Treated With Insulin; Pregnancy, High Risk
• Interventions: Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose); Device: Continuous Glucose Monitor

• Registration Number: NCT05317585
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-08
• Study Start: 2024-05-23
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-30
• Primary Completion: 2026-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fingerstick Glucose Monitoring	Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)	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 Monitoring (CGM)	Continuous Glucose Monitor	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.

Primary Outcome Measures

Name	Time	Method
Large for Gestational Age Infant	Within 2 hours of birth	The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery.

Secondary Outcome Measures

Name	Time	Method
Mode of Delivery	At delivery	Mode of delivery (vaginal versus cesarean)
Neonatal Respiratory Distress	At delivery	Neonatal Respiratory Distress requiring respiratory support
Third Trimester Hemoglobin A1c	Between 28 weeks and delivery	Third Trimester Hemoglobin A1c
Neonatal Intensive Care Unit Admission (NICU)	At delivery and within first 2 days of life	Neonatal Intensive Care Unit Admission (NICU)
Hypertensive Disorders of Pregnancy	After 20 weeks of gestation until delivery	Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation
Preterm Birth	At delivery	Preterm birth (delivery less than 37 weeks gestation)
Number of participants with a shoulder dystocia	At delivery	Number of participants with a shoulder dystocia
Gestational age at delivery	At Delivery	Gestational age at delivery
Maternal Patient Satisfaction Survey with Glucose Monitoring	postpartum day 1 after delivery	This will be assessed by the glucose monitoring satisfaction survey (GMSS) version 2. Participants will complete the survey, which contains 4 subscales and a total score. The subscales assess openness, emotional burden, behavioral burden, and worthwhileness. The higher the score the greater the satisfaction, with a total maximum score 75.
APGAR less than 7 at 5 minutes of life	5 Minutes after Delivery	APGAR score less than 7 at 5 minutes of life
Number of participants with neonatal hypoglycemia	Within 2 hours of birth	Number of participants with neonatal hypoglycemia as defined by first neonatal blood sugar obtained within 2 hours of birth

Trial Locations

Locations (1)

University of Massachusetts Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States