Clinical trial NCT04794478: Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System
Official title: Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 482
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Detailed description: The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Eligibility criteria: Inclusion Criteria:

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes
* Willing to wear the required number of Systems for the total duration of study wear
* Willing to participate in Clinic Session(s) during study wear

Exclusion Criteria:

* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification
* ≥ 18 years of age:

  * Male: 36.0%;
  * Female: 33.0%;
* 13-17 years of age: 35.0%;
* 7 years - 12 years of age: 32.0%;
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period

Primary outcomes:
measure: Dexcom Continuous Glucose Monitoring System Performance
timeFrame: 10 days
Secondary outcomes:
measure: System Related Adverse Device Effects
timeFrame: 10 days
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. (CTT)
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A.
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Ogden
country: United States
facility: Advanced Research
state: Utah
city: Charlottesville
country: United States
facility: UVA Center for Diabetes Technology
state: Virginia
Study officials:
References:
citation: Laffel LM, Bailey TS, Christiansen MP, Reid JL, Beck SE. Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes. J Diabetes Sci Technol. 2023 Jul;17(4):962-967. doi: 10.1177/19322968221091816. Epub 2022 Apr 25.
citation: Garg SK, Kipnes M, Castorino K, Bailey TS, Akturk HK, Welsh JB, Christiansen MP, Balo AK, Brown SA, Reid JL, Beck SE. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):373-380. doi: 10.1089/dia.2022.0011. Epub 2022 Feb 21.