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NCT04905628 Clinical Trial

Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04905628
Other study ID # PTL-904284
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 8, 2021
Est. completion date April 15, 2022

Study information
Verified date February 2022
Source DexCom, Inc.
Contact Stayce Beck, PhD, MPH
Phone 858-203-6454
Email PTL904284@dexcom.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 15, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Confirmed pregnancy - Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM) - Willing to wear up to the required number of Systems for the total duration of study wear - Able to follow study procedures; - Able to speak, read, and write in English or Spanish. Exclusion Criteria: - Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites - Known allergy to medical-grade adhesives - Hematocrit outside specification - Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy - Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period - Currently using Hydroxyurea for treatment - Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dexcom CGM System
Dexcom CGM System

Locations
Country Name City State
United States Barbara Davis Center for Childhood Diabetes Aurora Colorado
United States Joslin Diabetes Center Boston Massachusetts
United States Icahn School of Medicine at Mount Sinai New York New York
United States Oregon Health & Science University Portland Oregon
United States Sansum Diabetes Research Institute Santa Barbara California

Sponsors (1)
Lead Sponsor Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dexcom Continuous Glucose Monitoring (CGM) System Performance The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) comparator venous plasma measurements 10 Days
Secondary System Related Adverse Device Effects The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants 10 Days
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