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

• Conditions: Diabetes Mellitus
• Interventions: Device: Dexcom CGM System

• Registration Number: NCT04905628
• Lead Sponsor: DexCom, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Study Start: 2021-07-08
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-21
• Primary Completion: 2022-03-31
• Study Completion: 2022-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dexcom CGM System	Dexcom CGM System	Dexcom CGM System

Primary Outcome Measures

Name	Time	Method
Dexcom Continuous Glucose Monitoring (CGM) System Performance	10 Days	The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) comparator venous plasma measurements

Secondary Outcome Measures

Name	Time	Method
System Related Adverse Device Effects	10 Days	The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants

Trial Locations

Locations (5)

Barbara Davis Center for Childhood Diabetes; 🇺🇸 Aurora, Colorado, United States

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, 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