Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
1 other identifier
interventional
317
2 countries
18
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2022
CompletedResults Posted
Study results publicly available
June 2, 2023
CompletedJune 2, 2023
May 1, 2023
1.7 years
June 12, 2020
April 4, 2023
May 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Readings Within 20% Agreement
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.
7 days (170 hours)
Study Arms (1)
Subjects with diabetes wearing DS5
EXPERIMENTALSubjects wearing DS5 over 7 days and participating in FSTs.
Interventions
CGM and frequent sample testing
Eligibility Criteria
You may qualify if:
- Individual is 2 - 80 years of age at time of enrollment.
- Subject has a clinical diagnosis of type 1 or type 2 diabetes:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
AMCR Institute
Escondido, California, 92025, United States
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
SoCal Diabetes
Torrance, California, 90505, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045, United States
University of South Florida
Tampa, Florida, 33612, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133, United States
Texas Diabetes & Endocrinology
Austin, Texas, 78749, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057, United States
Nanjing First Hospital
Nanjing, Jiangsu, 210008, China
Dalian Municiple Central Hospital
Dalian, Liaoning, 116089, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310005, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robin Mottackel
- Organization
- Medtronic Diabetes
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 18, 2020
Study Start
July 15, 2020
Primary Completion
April 12, 2022
Study Completion
April 12, 2022
Last Updated
June 2, 2023
Results First Posted
June 2, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share