Clinical trial NCT04436822: Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
Official title: Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 317
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Detailed description: The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).

This is a multi-center study.

Eligibility criteria: Inclusion Criteria:

1. Individual is 2 - 80 years of age at time of enrollment.
2. Subject has a clinical diagnosis of type 1 or type 2 diabetes:

   1. If subject is 14-80 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
   2. If subject is 2-13 years of age, subject has a clinical diagnosis of type 1 or type 2 diabetes as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
3. If subject is participating in YSI™\* FST , subject has adequate venous access as assessed by investigator or appropriate staff.
4. Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity factor(s). Subjects without ratios may participate under observation only.

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
3. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
4. Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
5. Subject is a sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by investigator.
6. Subject is female and plans to become pregnant during the course of the study.
7. Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment.
8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
10. Subject has a history of a seizure disorder.
11. Subject has central nervous system or cardiac disorder resulting in syncope.
12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
13. If subject is 7-80 years of age, subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
14. Subject has a history of adrenal insufficiency.
15. Subject is a member of the research staff involved with the study.

Primary outcomes:
measure: Percentage of Readings Within 20% Agreement
timeFrame: 7 days (170 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Torrance
country: United States
facility: SoCal Diabetes
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes
state: Colorado
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Dalian
country: China
facility: Dalian Municiple Central Hospital
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: The Children's Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: