Status:
COMPLETED
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
2-80 years
Phase:
NA
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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2022
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT04436822
Start Date
July 15 2020
End Date
April 12 2022
Last Update
June 2 2023
Active Locations (18)
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1
AMCR Institute
Escondido, California, United States, 92025
2
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
3
SoCal Diabetes
Torrance, California, United States, 90505
4
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598