Continuous Glucose Monitor Use in Pregnancy

Study Overview
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Brief Summary
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The purpose of this study is to perform a randomized controlled trial among 162 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
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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 162 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.

Official Title
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Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

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

Intervention / Treatment
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* Device: Continuous Glucose Monitor
* Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring (CGM)<br>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. | Device: Continuous Glucose Monitor<br>* Continuous Glucose Monitor<br>|
| Active Comparator: Fingerstick Glucose Monitoring<br>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. | Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)<br>* Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Large for Gestational Age Infant | The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery. | Within 2 hours of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Third Trimester Hemoglobin A1c | Third Trimester Hemoglobin A1c | Between 28 weeks and delivery | 
| Mode of Delivery | Mode of delivery (vaginal versus cesarean) | At delivery | 
| Hypertensive Disorders of Pregnancy | Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation | After 20 weeks of gestation until delivery | 
| Preterm Birth | Preterm birth (delivery less than 37 weeks gestation) | At delivery | 
| Number of participants with a shoulder dystocia | Number of participants with a shoulder dystocia | At delivery | 
| Neonatal Intensive Care Unit Admission (NICU) | Neonatal Intensive Care Unit Admission (NICU) | At delivery and within first 2 days of life | 
| Neonatal Respiratory Distress | Neonatal Respiratory Distress requiring respiratory support | At delivery | 
| APGAR less than 7 at 5 minutes of life | APGAR score less than 7 at 5 minutes of life | 5 Minutes after Delivery | 
| Number of participants with neonatal hypoglycemia | Number of participants with neonatal hypoglycemia as defined by first neonatal blood sugar obtained within 2 hours of birth | Within 2 hours of birth | 
| Gestational age at delivery | Gestational age at delivery | At Delivery | 
| Maternal Patient Satisfaction Survey with Glucose Monitoring | 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. | postpartum day 1 after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Pregnancy