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

Not Applicable

Withdrawn

• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Interventions: Device: Harmony 1 Sensor

• Registration Number: NCT02456922
• Lead Sponsor: Medtronic Diabetes

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Study Start: 2018-07
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Harmony 1 Sensor	Subjects wearing Harmony 1 Sensor for up to 10 days.

Primary Outcome Measures

Name	Time	Method
Harmony 1 Sensor accuracy	10 days	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.