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Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy

NCT02556554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2020-07-21

Study results available
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Summary

A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities during pregnancy associated with T1DM.

Conditions

  • Diabetes Mellitus, Type I

Interventions

DEVICE

Dexcom G4 or G5 Platinum CGM system

Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy

DEVICE

Dexcom G4 or G5 Platinum CGM system with Share

Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Sarit Polsky, MD, MPH · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-08-31
Completion
2017-08-31

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 NCT02556554 on ClinicalTrials.gov