Pregnancy, High Risk, Type 2 Diabetes Treated With Insulin
Conditions
Keywords
Type 2 diabetes, Pregnancy
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.
Interventions
DEVICEContinuous Glucose Monitor
Continuous Glucose Monitor
DEVICERoutine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Third Trimester Hemoglobin A1c | Between 28 weeks and delivery | Third Trimester Hemoglobin A1c |
| Mode of Delivery | At delivery | Mode of delivery (vaginal versus cesarean) |
| 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 |
| Neonatal Intensive Care Unit Admission (NICU) | At delivery and within first 2 days of life | Neonatal Intensive Care Unit Admission (NICU) |
| Neonatal Respiratory Distress | At delivery | Neonatal Respiratory Distress requiring respiratory support |
| 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 |
| 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. |
Countries
United States
Contacts
CONTACTGianna L Wilkie, MD
CONTACTHeidi Leftwich, DO
PRINCIPAL_INVESTIGATORGianna L Wilkie, MD
University of Massachusetts, Worcester
Outcome results
None listed