Last updated: February 17, 2022
Sponsor: DexCom, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes And Hypertension
Diabetes Prevention
Treatment
N/AClinical Study ID
NCT04905628
PTL-904284
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years
- Confirmed pregnancy
- Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2Diabetes Mellitus (T2DM)
- Willing to wear up to the required number of Systems for the total duration of studywear
- Able to follow study procedures;
- Able to speak, read, and write in English or Spanish.
Exclusion
Exclusion Criteria:
- Extensive skin changes/diseases that preclude wearing the required number of Systemsat 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 pregnancycomplications during current pregnancy
- Currently receiving dialysis treatment or planning to receive dialysis during thesensor wear period
- Currently using Hydroxyurea for treatment
- Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, ordiathermy during the sensor wear period
Study Design
Total Participants: 100
Study Start date:
July 08, 2021
Estimated Completion Date:
April 15, 2022
Connect with a study center
Sansum Diabetes Research Institute
Santa Barbara, California 93105
United StatesActive - Recruiting
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado 80045
United StatesActive - Recruiting
Joslin Diabetes Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Oregon Health & Science University
Portland, Oregon 97239
United StatesActive - Recruiting

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