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

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Gestational Diabetes

Treatments: Diagnostic Test: Self-Capillary Blood Glucose Monitoring (SCBG); Diagnostic Test: Continuous glucose monitoring (CGM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04605497

STUDY00021775

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually.

Treatment:

Diagnostic Test: Continuous glucose monitoring (CGM)

Referent Arm

Other group

Description:

Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks.

Treatment:

Diagnostic Test: Self-Capillary Blood Glucose Monitoring (SCBG)