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

NCT04605497 | Completed FDA Device

• 1 other identifier: STUDY00021775
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes

Keywords

Female; pregnancy; gestational diabetes

Outcome Measures

Primary Outcomes (1)

• Average time-in-range over a 24 hour period

  From enrollment to10 days after discharge from hospital following delivery

Secondary Outcomes (2)

• Average time-in-range during waking hours

  From enrollment to10 days after discharge from hospital following delivery

• Average time-in-range while asleep

  From enrollment to10 days after discharge from hospital following delivery

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Diagnostic Test: Continuous glucose monitoring (CGM)

Referent Arm

OTHER

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

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

Interventions

Continuous glucose monitoring (CGM) DIAGNOSTIC_TEST

Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission \& discharge + additional 10 days during postpartum period

Intervention Arm

Self-Capillary Blood Glucose Monitoring (SCBG) DIAGNOSTIC_TEST

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

Referent Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Continuous Glucose Monitoring

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Amy Valent

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: February 11, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

US (1)