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

  • STATUS
    Recruiting
  • participants needed
    376
  • sponsor
    Medtronic Diabetes
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Updated on 16 February 2024
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insulin sensitivity
continuous glucose monitoring
type 1 diabetes mellitus
diabetes
type 2 diabetes mellitus
insulin

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).

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.

Details
Condition NIDDM, diabetes mellitus, type 2, Diabetes Mellitus, diabetes (pediatric), Insulin dependent diabetes mellitus, diabetes (pediatric), diabetes mellitus, type 2
Age 2years - 80years
Treatment Continuous Glucose Monitoring
Clinical Study IdentifierNCT04436822
SponsorMedtronic Diabetes
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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 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 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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insulin sensitivity
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