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

Oregon Health & Science University (OHSU) logo

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)

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)

Trial contacts and locations

1

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Central trial contact

Women's Health Research Unit Department of Ob/Gyn

Data sourced from clinicaltrials.gov

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