NCT05537480

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.8 years

First QC Date

October 7, 2021

Last Update Submit

September 11, 2022

Conditions

Pregnancy ComplicationsDiabetes MellitusHyperglycemic Disorder

Outcome Measures

Primary Outcomes (1)

  • Obtain CGM data concomitant with OGTT 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)

    blood level will be measured of CGM versus self monitoring blood glucose

    2 years

Secondary Outcomes (7)

  • Compare GDM diagnosis using the 1-step and 2-step OGTT

    2 years

  • Obtain CGM data concomitant with OGTT while comparing reproducibility of the 1-step and 2-step methods

    2 years

  • Determine what CGM metrics obtained concomitant with OGTT correlate best with maternal and fetal outcomes in pregnant women with and without diagnosed GDM

    2 years

  • Determine how dysglycemia evolves over the third trimester in women with or without diagnosed GDM

    2 years

  • Compare hyperglycemia determined with CGM to hyperglycemia determined by SMBG in participants diagnosed with GDM

    2 years

  • +2 more secondary outcomes

Study Arms (2)

Normal GCT

OTHER

Women with GCT \<140mg/dl

Device: Continuous glucose monitoring device

Abnormal GCT

OTHER

Women with GCT \>=140mg/dl

Device: Continuous glucose monitoring device

Interventions

Continuous glucose monitoring deviceDEVICE

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

Also known as: CGM, DEXCOM PRO G6
Abnormal GCTNormal GCT

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women at high risk for GDM based on GCT results
  • Pregnant women at low risk for GDM based on GCT results.
  • Had an ultrasound earlier before 12 weeks to confirm gestational age
  • Singleton pregnancy

You may not qualify if:

  • Pregestational diabetes or overt diabetes diagnosed during enrollment
  • Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long-term medical condition at the investigator's discretion
  • Known (or suspected) allergy to medical grade adhesives
  • Use of hydroxyurea (a known interferent of CGM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Souraski MC

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Pregnancy ComplicationsDiabetes MellitusHyperglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Liran Hirsh, prof

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All are blinded to the CGM results.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Clinical Trails Department, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

October 7, 2021

First Posted

September 13, 2022

Study Start

January 14, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2024

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)