Recruiting

Observational Study

Sponsor:

DexCom, Inc.

Code:

NCT03340831

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitoring (CGM)

Study Details

Brief summary:

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

Conditions

Diabetes

Study ID

NCT03340831

Start date

Oct 20, 2017

Status verified date

Sep, 2021

Completion date

Dec 30, 2023

Anticipated

Primary completion date

Dec 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1388 participants

Anticipated

Interventions and Outcome Measures

Arms

CGM/BGM Group

single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA).

Interventions

Continuous Glucose Monitoring (CGM)

Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)

Primary outcome measure

  • Change in hypoglycemic events [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Stayce Beck, PhD, MPH

8582036454stayce.beck@dexcom.com

Nelly Njeru

8582036379nelly.njeru@dexcom.com

Locations

Centre of Excellence in Diabetes and Endocrinology

Recruiting

Sacramento, California, United States, 95821

Contacts

Mila Melnik

cedelead@yahoo.com

Principal Investigator:

Gnanagurudasan Prakasam, M.D.

Intervent Clinical Research Center

Recruiting

Pembroke Pines, Florida, United States, 33024

Contacts

Marisela Rodriguez

954-507-6627mrodriguez@interventcrc.com

Principal Investigator:

Diego Montes, MD

University of South Florida Clinical Research Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Ponja Hemphill

phemphill@usf.edu

Janet Rodriguez

janetrodriguez@usf.edu

Principal Investigator:

Henry Rodriguez, M.D.

Cotton O'Neil Clinical Research

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Jaime Berroth

JBerroth@stormontvail.org

Principal Investigator:

Susan Brian, M.D.

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Jennifer L James

jljames@cmh.edu;

Principal Investigator:

Mark Clements, M.D.,PhD.

University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

LInda Weber

Linda-weber@ouhsc.edu

Principal Investigator:

David Sparling, M.D.

Amarillo Medical Specialists, LLP

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Becky Cota, RN, CDE

806-358-8331becky.cota@amarillomed.com

Principal Investigator:

William Biggs, M.D.

Advanced Research Associates

Recruiting

Ogden, Utah, United States, 84405

Contacts

Hilary Wahlen

801-409-2040hilary@advresearch.org

Principal Investigator:

Jack Wahlen, M.D., PhD

More Information

Sponsor

DexCom, Inc.

Last update posted

Sep 21, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by DexCom, Inc. on 2021-09-21.