Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
1 other identifier
interventional
335
1 country
15
Brief Summary
The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm 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 Jun 2019
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
June 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2020
CompletedResults Posted
Study results publicly available
June 7, 2021
CompletedJune 7, 2021
May 1, 2021
11 months
May 23, 2019
March 30, 2021
May 11, 2021
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 if sensor values \< 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.
7 days (170 hours)
Study Arms (1)
Subjects with diabetes wearing Guardian™ Sensor (3)
OTHERSubjects wear Guardian™ Sensor (3) and Guardian™ Connect Transmitter over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.
Interventions
Continuous Glucose Monitoring and frequent sample testing
Eligibility Criteria
You may qualify if:
- Individual is 2 - 80 years of age at time of enrollment
- A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- 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 ratio. Subjects without ratios may participate under observation only
You may not qualify if:
- Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) 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 (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- Subject is female and has a positive pregnancy screening test
- Female of child bearing age and who is sexually active should be excluded if she 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
- Subject has a hematocrit (Hct) lower than the 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 (15)
AMCR Institue
Escondido, California, 92026, United States
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
SoCal Diabetes
Torrance, California, 90505, United States
Diablo Clinical Research
Walnut Creek, California, 92025, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Barbara Davis Center - Adults
Aurora, Colorado, 80045, United States
Barbara Davis Center for Childhood Diabetes (Pediatric)
Aurora, Colorado, 80045, United States
University of South Florida
Tampa, Florida, 33613, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
IDERC
Des Moines, Iowa, 50265, United States
Mayo Clinic (Rochester MN)
Rochester, Minnesota, 55905, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78749, United States
University of Virgina
Charlottesville, Virginia, 22903, United States
Rainer Clinical Research Center
Renton, Washington, 98057, United States
MeSH Terms
Conditions
Condition 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
May 23, 2019
First Posted
May 29, 2019
Study Start
June 14, 2019
Primary Completion
May 13, 2020
Study Completion
May 13, 2020
Last Updated
June 7, 2021
Results First Posted
June 7, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share