Continuous Monitoring and Control of Hypoglycemia



Status:Recruiting
Healthy:No
Age Range:2 - Any
Updated:4/3/2019
Start Date:October 20, 2017
End Date:May 15, 2020
Contact:Paul Genge
Email:Paul.Genge@dexcom.com
Phone:3109384075

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Post Approval Study for Non-Adjunctive Use of Dexcom G5 CGM System for Diabetes Management

Evaluate safety of non-adjunctive CGM use in CGM naive participants.

The study comprises recruitment and consenting of pediatric and adult participants. At entry,
the following information will be collected: demographics, labs, clinical and diabetes
history information (history of mild/severe hypoglycemia or DKA events in the past 6 months
and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 .
Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events
and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency
of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to
assess for CGM adherence.

Inclusion Criteria:

- Naïve to real-time CGM

- Type 1 or insulin-requiring Type 2 diabetes

- ≥ 2 years old

Exclusion Criteria:

- Use of RT-CGM, within the past 12 months

- Pregnancy

- Concomitant disease or condition that may compromise patient safety including and not
limited to severe mental illness, a diagnosed or suspected eating disorder or any
uncontrolled long term medical condition that would interfere with study related tasks
or visits, or ongoing treatment for a significant malignancy.

- Known (or suspected) significant allergy to medical grade adhesives

- Dialysis
We found this trial at
18
sites
Ogden, Utah 84405
Principal Investigator: Jack Wahlen, MD, PhD
Phone: 801-409-2040
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Mark Clements, M.D.,Ph.D.
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Amarillo, Texas 79106
Principal Investigator: William Biggs, MD
Phone: 806-358-8331
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Asheville, North Carolina 28803
Principal Investigator: Wendy Lane, MD
Phone: 828-684-9588
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Atlanta, Georgia 30318
Principal Investigator: Bruce Bode, MD
Phone: 404-355-4393
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Austin, Texas 78731
Principal Investigator: Thomas Blevins, MD
Phone: 512-334-3505
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Dallas, Texas 75231
Principal Investigator: Stephen Aronoff, MD
Phone: 214-265-2137
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Des Moines, Iowa 50314
Principal Investigator: Anuj Bhargava, MD
Phone: 515-643-5122
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Des Moines, IA
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Idaho Falls, Idaho 83404
Principal Investigator: David Liljenquist, MD
Phone: 208-522-6005
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Idaho Falls, ID
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La Jolla, California
Principal Investigator: Athena Philis-Tsimikas, MD
Phone: 858-336-3414
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La Mesa, California 91942
Principal Investigator: Raymond Fink, M.D.
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Minneapolis, Minnesota 55416
Principal Investigator: Amy Criego, MD
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Nashville, Tennessee 37232
Principal Investigator: Shichun Bao, M.D.
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Omaha, Nebraska 68114
Principal Investigator: Sarah Konigsberg, MD
Phone: 402-561-2662
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Omaha, NE
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Sacramento, California 95821
Principal Investigator: Gnanagurudasan Prakasam, M.D.
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100 South San Mateo Drive
San Mateo, California 94401
Principal Investigator: David Klonoff, MD
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317 West Pueblo Street
Santa Barbara, California 93105
Principal Investigator: Kristin Castorino, DO
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Skokie, Illinois 60077
Principal Investigator: Lianna Billings, MD
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