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
	
									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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								Idaho Falls, Idaho 83404			
	
			
					Principal Investigator: David Liljenquist, MD
			
						
										Phone: 208-522-6005
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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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