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 |
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.
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
Idaho Falls, Idaho 83404
Principal Investigator: David Liljenquist, MD
Phone: 208-522-6005
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2401 Gillham Rd
Kansas City, Missouri 64108
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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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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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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Ogden, Utah 84405
Principal Investigator: Jack Wahlen, MD, PhD
Phone: 801-409-2040
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Omaha, Nebraska 68114
Principal Investigator: Sarah Konigsberg, MD
Phone: 402-561-2662
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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
San Mateo, California 94401
Principal Investigator: David Klonoff, MD
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317 West Pueblo Street
Santa Barbara, California 93105
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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