Clinical trial NCT04803357: A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Official title: A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2021-03-17
Enrollment: 107
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Real- time continuous glucose monitoring using the DexCom G6.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Health of mother using CGM to monitor blood glucose during pregnancy
timeFrame: 4 years
measure: Health of baby using delivery and post delivery well baby assessments
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Nicole M Ehrhardt, MD
role: PRINCIPAL_INVESTIGATOR
References: