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

NCT04605497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2024-05-31

No results posted yet for this study

Summary

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

Conditions

  • Gestational Diabetes

Interventions

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

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Amy Valent · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04605497 on ClinicalTrials.gov