Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics

Not Applicable

Completed

Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Interventions: Device: Continuous Glucose Monitoring

Registration Number: NCT04436822

Lead Sponsor: Medtronic Diabetes

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 317

Inclusion Criteria

Individual is 2 - 80 years of age at time of enrollment.
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.
If subject is participating in YSI™* FST , subject has adequate venous access as assessed by investigator or appropriate staff.
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

Subject will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
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.)
Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
Subject is a sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by investigator.
Subject is female and plans to become pregnant during the course of the study.
Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment.
Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
Subject has a history of a seizure disorder.
Subject has central nervous system or cardiac disorder resulting in syncope.
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
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).
Subject has a history of adrenal insufficiency.
Subject is a member of the research staff involved with the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with diabetes wearing DS5	Continuous Glucose Monitoring	Subjects wearing DS5 over 7 days and participating in FSTs.

Primary Outcome Measures

Name	Time	Method
Percentage of Readings Within 20% Agreement	7 days (170 hours)	Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (18): Atlanta Diabetes Associates
🇺🇸
Atlanta, Georgia, United States
AM Diabetes and Endocrinology Center
🇺🇸
Bartlett, Tennessee, United States
Dalian Municiple Central Hospital
🇨🇳
Dalian, Liaoning, China
Nanjing First Hospital
🇨🇳
Nanjing, Jiangsu, China
The Children's Hospital Zhejiang University School of Medicine
🇨🇳
Hangzhou, Zhejiang, China
University of South Florida
🇺🇸
Tampa, Florida, United States
Children's Hospital of Fudan University
🇨🇳
Shanghai, Shanghai, China
SoCal Diabetes
🇺🇸
Torrance, California, United States
Texas Diabetes & Endocrinology
🇺🇸
Austin, Texas, United States
Rocky Mountain Diabetes and Osteoporosis Center
🇺🇸
Idaho Falls, Idaho, United States
Sansum Diabetes Research Institute
🇺🇸
Santa Barbara, California, United States
AMCR Institute
🇺🇸
Escondido, California, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸
Aurora, Colorado, United States
University of Virginia Center for Diabetes Technology
🇺🇸
Charlottesville, Virginia, United States
Diablo Clinical Research, Inc.
🇺🇸
Walnut Creek, California, United States
Rainier Clinical Research Center, Inc.
🇺🇸
Renton, Washington, United States
Barbara Davis Center for Diabetes
🇺🇸
Aurora, Colorado, United States
Shanghai Sixth People's Hospital
🇨🇳
Shanghai, Shanghai, China