Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medtronic Diabetes
- Enrollment
- 335
- Locations
- 15
- Primary Endpoint
- Percentage of Readings Within 20% Agreement
Study Overview
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).
Detailed Description
The study is a multi-center, prospective, single-sample correlational design without controls. 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Subjects with diabetes wearing Guardian™ Sensor (3)
Subjects wear Guardian™ Sensor (3) and Guardian™ Connect Transmitter over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.
Intervention: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter (Device)
Outcomes
Primary Outcomes
Percentage of Readings Within 20% Agreement
Time Frame: 7 days (170 hours)
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.
Secondary Outcomes
No secondary outcomes reported