A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Mean Glucose
Study Overview
Brief Summary
The purpose of this study is to examine whether RT-CGM (real time continuous glucose monitoring) use improves glucose control, maternal outcomes, and fetal outcomes in patients diagnosed with gestational diabetes. Currently, there is very limited data on whether RT-CGM use helps patients diagnosed with gestational diabetes. By conducting this study, the investigator hopes to develop a deeper understanding of how use of a RT-CGM may affect glucose control in the gestational diabetes population.
Detailed Description
Pregnant Participants diagnosed with gestational diabetes are being invited to take part in a research study because these participants are pregnant and have gestational diabetes. Participants will be offered an opportunity to wear a medical device that monitors blood sugars (glucose). This device is called a continuous glucose monitor (CGM). The CGM measures glucose levels through a tiny plastic filament that is inserted under the skin in the abdomen by a skin prick. Typically, participants cannot feel this device once it is inserted. If participants agree to participate in this study, participants will be randomly placed into one of two groups: (1) the intervention group or (2) the control group. Participants will have a 50% (1 out of 2) chance like a coin toss of being placed into either group. If participants are in the intervention group, they will wear a real-time continuous glucose monitoring device (RT-CGM). The RT-CGM will allow participants to see glucose levels in real time. The RT-CGM will send information about glucose levels to a phone or display device so participants may see the glucose at all times. If participants are in the control group, they will not be given a RT-CGM. Instead, participants will be given a blinded CGM device. You will not be able to view your blood sugar results on the blinded CGM device. If participants are in the control group, they will also be given a blood glucose meter to check glucose using finger sticks according to the recommendations of the provider.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
If you are in the control group, you will not be given a RT-CGM. Instead, you will be given a blinded CGM device. You will not be able to view your blood sugar results on the blinded CGM device. If you are in the control group, you will also be given a blood glucose meter to check your glucose using finger sticks according to the recommendations of your provider.
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnancy and Gestation < 30 weeks
- •Singleton pregnancy
- •Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)
- •Able to read English and completed 6th grade
- •Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements
Exclusion Criteria
- •Pre-gestational Type 1 or Type 2 diabetes.
- •Newly diagnosed overt-diabetes in pregnancy [HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l].
- •Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM
- •Known endogenous/exogenous Cushing's syndrome
- •Known chronic infections
- •Current use of any oral form of steroid medication
- •Already receiving continuous glucose monitoring (CGM)
- •History of bariatric surgery
- •Gestational Age less than 14 weeks -
Arms & Interventions
Control : Blinded Continuous Glucose Monitoring (CGM)
If you are in the control group, you will wear a continuous glucose monitor but it will be blinded during pregnancy.
Intervention: Real Time -Continuous Glucose Monitoring (RT-CGM)
Wearing RT- CGM during pregnancy
Intervention: Continuous glucose monitor (Device)
Outcomes
Primary Outcomes
Mean Glucose
Time Frame: 36 weeks
mean glucose CGM
TIR CGM
Time Frame: 36 weeks
Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring
Secondary Outcomes
- A1c(36 weeks)
- Fetal Birthweight(delivery)
- TBR CGM GDM(36 weeks)
- TAB CGM GDM(36 weeks)
- MAGE CGM(36 weeks)
- SD CGM(36 weeks)
- CV CGM(36 weeks)
- Neonatal Hypoglycemia(delivery)
- Gestational Age at Delivery(delivery)
- Mode of Delivery(delivery)
- Type of Labor(delivery)
- Shoulder Dystocia(delivery)
- Preeclampsia or HTN(delivery)
- Maternal Weight Gain(delivery)
- Diabetes Medication Use(at 36 weeks)
- 5 Minute Apgar(delivery)
- Live Birth or Stillbirth(devlivery)
- Birthweight Ratio(delivery)
- NICU Admission(delivery)
- Neonatal Complications(delivery)
- Glucose Meter Fingerstick Per Day(36 weeks)
- Mean Days of RT-CGM Use(36 weeks)
- Fructosamine(36 weeks)
- Short Food Questionnaire(36 weeks)
- WHO QOL Scale(36 weeks)
- Diabetes Distress(PAID) Survey(36 weeks)
- Walking Time Physcial Active Questionnaire(36 weeks)
- Metformin Only Use(at 36 weeks)
- Insulin Use Only(at delivery)
- Diabetes Medication Use Delivery(at delivery)
- Metformin Use Only at Delivery(at delivery)
- Insulin Use Only(at 36 weeks)
Investigators
Nicole Ehrhardt
Assistant Professor, School of Medicine
University of Washington