Clinical trial NCT03340831: Continuous Monitoring and Control of Hypoglycemia
Official title: Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 1388
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and pediatrics (2 or older), naïve to CGM, with Type 1 or insulin-requiring Type 2 diabetes

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hypoglycemic events
timeFrame: 6 months
Secondary outcomes:
measure: Change in A1C
timeFrame: 6 months
measure: Change in incidence of hypoglycemic events
timeFrame: 6 months
measure: Change in GMSS PRO scores
timeFrame: 6 months
measure: Change in Diabetes Distress Scale (DDS) PRO scores
timeFrame: 6 months
measure: Change in Hypoglycemia Fear PRO scores
timeFrame: 6 months
measure: Change in Hypoglycemia Confidence PRO scores
timeFrame: 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: La Mesa
country: United States
facility: Diabetes and Endocrine Associates
state: California
city: Sacramento
country: United States
facility: Centre of Excellence in Diabetes and Endocrinology
state: California
city: San Mateo
country: United States
facility: Mills-Peninsula Medical Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Gainesville
country: United States
facility: University of Florida Pediatric Endocrinology
state: Florida
city: Pembroke Pines
country: United States
facility: Intervent Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida Clinical Research Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes Center
state: Idaho
city: Skokie
country: United States
facility: Northshore University Health System
state: Illinois
city: Des Moines
country: United States
facility: Iowa Diabetes & Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research
state: Kansas
city: Minneapolis
country: United States
facility: International Diabetes Research Center
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Omaha
country: United States
facility: Methodist Physicians Clinic - Diabetes and Endocrine Specialists
state: Nebraska
city: Asheville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants, PC
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt Eskind Diabetes Clinic
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Medical Specialists, LLP
state: Texas
city: Austin
country: United States
facility: Texas Diabetes and Endocrine
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Ogden
country: United States
facility: Advanced Research Associates
state: Utah
Study officials:
affiliation: Dexcom-Medical Affairs
name: David Price, MD
role: STUDY_DIRECTOR
References: