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Correlation of CGM Metrics With OGTT and Pregnancy Outcomes in Pregnant Women With or Without a High Risk for GDM

NCT05537480 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2022-09-13

No results posted yet for this study

Summary

the aim of the study is to obtain CGM data concomitant with OGTT and to determine what CGM metrics obtained in pregnant women with and without a high risk of GDM correlate best with the diagnostic OGTT (obtained via the 2-step and 1-step approaches).

Conditions

Interventions

DEVICE

Continuous glucose monitoring device

Continuous glucose monitoring device will be worn by participants during several periods.

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Liran Hirsh, prof · Tel Aviv Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2023-11-01
Completion
2024-11-01
FDA Device
Yes

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT05537480 on ClinicalTrials.gov