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

NCT04803357 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00011755
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (2)

• Mean Glucose

  mean glucose CGM

  36 weeks

• TIR CGM

  Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring

  36 weeks

Secondary Outcomes (32)

• Fetal Birthweight

  delivery

• TBR CGM GDM

  36 weeks

• TAB CGM GDM

  36 weeks

• MAGE CGM

  36 weeks

• SD CGM

  36 weeks

Study Arms (2)

Control : Blinded Continuous Glucose Monitoring (CGM)

NO INTERVENTION

If you are in the control group, you will wear a continuous glucose monitor but it will be blinded during pregnancy.

Intervention: Real Time -Continuous Glucose Monitoring (RT-CGM)

ACTIVE COMPARATOR

Wearing RT- CGM during pregnancy

Device: Continuous glucose monitor

Interventions

Continuous glucose monitor DEVICE

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.

Intervention: Real Time -Continuous Glucose Monitoring (RT-CGM)

Eligibility Criteria

• Gender Eligibility Details: A female who is pregnant
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy and Gestation \< 30 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University of Washington: lead
• DexCom, Inc.: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

high dropout rate/withdrawal immediately after randomization leading to lower number of subject analysis. Unreliable data given reporting in EMR varied for certain metrics for maternal/fetal outcomes.

Results Point of Contact

• Title: Dr, Nicole Ehrhardt
• Organization: university of Washington Diabetes Institute

nehrhard@uw.edu

2404479566

Study Officials

• Nicole M Ehrhardt, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: If you are in the control group, you will not be given a RT-CGM. Instead, you will be given a blinded CGM device. You will not be able to view your blood sugar results on the blinded CGM device. If you are in the control group, you will also be given a blood glucose meter to check your glucose using finger sticks according to the recommendations of your provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Model Details: Real- time continuous glucose monitoring using the DexCom G6.

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: March 17, 2021
• Study Start: April 10, 2021
• Primary Completion: October 1, 2024
• Study Completion: January 15, 2025
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)