Continuous Glucose Monitor Use in Pregnancy
Type 2 Diabetes Treated With Insulin, Pregnancy, High Risk
About this trial
This is an interventional prevention trial for Type 2 Diabetes Treated With Insulin focused on measuring Type 2 diabetes, Pregnancy
Eligibility 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
Sites / Locations
- University of Massachusetts Memorial Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Continuous Glucose Monitoring (CGM)
Fingerstick Glucose Monitoring
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.
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.