A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics

Medtronic

Status

Withdrawn

Conditions

Type 1 Diabetes

Type 2 Diabetes

Treatments

Device: Harmony 1 Sensor

Study type

Interventional

Funder types

Industry

Identifiers

NCT02456922

CEP301

Details and patient eligibility

About

The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 2 - 75 years

Full description

This study is a multi-center, randomized, prospective single-sample correlational design without controls. A total of up to 310 previously-diagnosed type 1 or 2 diabetes subjects will be enrolled in order to have 160 subjects complete frequent sample testing at up to 17 centers. Subjects will wear Harmony 1 sensors used with the Guardian Mobile application.

Sex

All

Ages

2 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is 2-75 years of age at time of screening
A clinical diagnosis of type 1 or 2 diabetes for a minimum of 12 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 established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.

Exclusion criteria

Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individuals
Subject has any unresolved adverse skin condition in the area of Harmony 1 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
Females of child bearing age and who are sexually active should be excluded if they are 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
Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit.
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
Subject has a history of adrenal insufficiency