A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.

Detailed Description
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The study is a multi-center, prospective single-sample correlational design without controls.

Official Title
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A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Harmony 1 Sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 14 - 75 years of age at time of screening 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 Exclusion Criteria: Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individual. 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Harmony 1 Sensor Group A<br>Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 90 minutes after sensor insertion. | Device: Harmony 1 Sensor<br>* Use of Harmony 1 Sensor for 10 days when inserted in the arm and abdomen and used with the Guardian Mobile in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 6 months.<br>|
| Other: Harmony 1 Sensor Group B<br>Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 12 hours after sensor insertion. | Device: Harmony 1 Sensor<br>* Use of Harmony 1 Sensor for 10 days when inserted in the arm and abdomen and used with the Guardian Mobile in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour calibration requirement | Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Type 2 Diabetes, Harmony Sensor, Continuous Glucose Monitoring, CGM