NCT04803357

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DEVICE	Continuous glucose monitor	We are offering you an opportunity to wear a medical device that monitors your 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 your abdomen by a skin prick. Typically, you cannot feel this device once it is inserted.

Timeline

• Start date: 2021-04-10
• Primary completion: 2024-10-01
• Completion: 2025-01-15
• First posted: 2021-03-17
• Last updated: 2025-06-25
• Results posted: 2025-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study