Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04803357
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2020-11-29
Brief Title:
A Study on the Use of Real -Time Continuous Glucose Monitoring RT-CGM in Gestational Diabetes
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Study on the Use of Real -Time Continuous Glucose Monitoring RT-CGM in Gestational Diabetes
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None