Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

Official title:

A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605497
• Other study ID #: STUDY00021775
• Status: Completed
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age 18-55 years
• Singleton pregnancy =20 weeks gestation
• Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan)
• Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver

Exclusion Criteria:

• Chronic immunosuppression
• Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder
• Known allergy to medical grade adhesives
• Pre-gestational diabetes
• Multifetal gestation
• Current alcohol or illicit drug use
• Simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• Continuous glucose monitoring (CGM)
Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission & discharge + additional 10 days during postpartum period
• Self-Capillary Blood Glucose Monitoring (SCBG)
Conventional SCBG 4x/day testing (standard care in Oregon; fasting and 1-hour postprandial) with blinded CGM every 2 weeks SCBG 4 times/day until delivery admission 10 days duration with each blinded CGM wear

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average time-in-range over a 24 hour period		From enrollment to10 days after discharge from hospital following delivery
Secondary	Average time-in-range during waking hours		From enrollment to10 days after discharge from hospital following delivery
Secondary	Average time-in-range while asleep		From enrollment to10 days after discharge from hospital following delivery