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Continuous Glucose Monitor Use in Pregnancy

ConditionsType 2 Diabetes Treated With InsulinPregnancy, High Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Massachusetts, Worcester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Continuous Glucose Monitor

    Device

    Continuous Glucose Monitor

  • Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

    Device

    Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Continuous Glucose Monitoring (CGM)Experimental treatment 1 intervention
Group B: Fingerstick Glucose MonitoringActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 2 hours of birth

Secondary outcomes

1

Third Trimester Hemoglobin A1c

Third Trimester Hemoglobin A1c

Time frame
Between 28 weeks and delivery
2

Mode of Delivery

Mode of delivery (vaginal versus cesarean)

Time frame
At delivery
3

Hypertensive Disorders of Pregnancy

Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation

Time frame
After 20 weeks of gestation until delivery
4

Preterm Birth

Preterm birth (delivery less than 37 weeks gestation)

Time frame
At delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

Source ClinicalTrials.gov
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