A Performance Evaluation 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 2 - 75 years

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes, Type 2 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 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

Ages Eligible for Study
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Minimum Age: 2 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Subjects wearing Harmony 1 Sensor for up to 10 days. | Device: Harmony 1 Sensor<br>* Use of Harmony 1 Sensor over 10 days in arm and abdomen and used with the Guardian Mobile App in subjects aged 2-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harmony 1 Sensor accuracy | Sensor accuracy will be evaluated compared to YSI plasma glucose values during frequent sample testing. A within 30% mean agreement rate (±22.5 mg/dL when Reference BG ≤ 75 mg/dL) between sensor and YSI will be evaluated against the null Hypothesis for varying glucose ranges. | 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 1