A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    100
  • sponsor
    University of Washington
Updated on 24 June 2021
diabetes
oral glucose tolerance test
prenatal
hemoglobin a1c
glucose tolerance test
sugars
continuous glucose monitoring

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.

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.

Details
Condition Diabetes Prevention, Diabetes Mellitus Types I and II, Gestational Diabetes, Diabetes (Pediatric), Pregnancy Complications, Diabetes Mellitus
Treatment Continuous Glucose Monitor
Clinical Study IdentifierNCT04803357
SponsorUniversity of Washington
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pregnancy and Gestation < 28 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 -
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