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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803357
• Other study ID #: STUDY00011755
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2022
• Source: University of Washington
• Contact: Ghada Abdalla
• Phone: 206-543-1836
• Email: gdmcgmstudy[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Pregnancy and Gestation < 28 weeks

2. Singleton pregnancy

3. Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)

4. Able to read English and completed 6th grade

5. 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:

1. Pre-gestational Type 1 or Type 2 diabetes.

2. Newly diagnosed overt-diabetes in pregnancy [HbA1c = 48 mmol/mol (6.5%), fasting glucose = 7.0 mmol/l, random glucose = 11.1 mmol/l].

3. Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM

4. Known endogenous/exogenous Cushing's syndrome

5. Known chronic infections

6. Current use of any oral form of steroid medication

7. Already receiving continuous glucose monitoring (CGM)

8. History of bariatric surgery

9. Gestational Age less than 14 weeks -

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health of mother using CGM to monitor blood glucose during pregnancy	Continuous glucose monitoring in gestational diabetes	4 years
Primary	Health of baby using delivery and post delivery well baby assessments	Continuous glucose monitoring in gestational diabetes	4 years