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

Not Applicable

Withdrawn

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

• Registration Number: NCT02646878
• Lead Sponsor: Medtronic Diabetes

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-12-22
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

1. Subject is 14 - 75 years of age at time of screening
2. 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
3. Adequate venous access as assessed by investigator or appropriate staff

Exclusion Criteria

1. Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individual.
2. Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. 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
4. Subject is female and has a positive pregnancy screening test
5. 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
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has had a hypoglycemic seizure within the past 6 months
8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit.
9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit.
10. Subject has a history of a seizure disorder
11. Subject has central nervous system or cardiac disorder resulting in syncope
12. 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
13. Subject has a hematocrit (Hct) lower than the normal reference range
14. Subject has a history of adrenal insufficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Harmony 1 Sensor Group A	Harmony 1 Sensor	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.
Harmony 1 Sensor Group B	Harmony 1 Sensor	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.

Primary Outcome Measures

Name	Time	Method
24 hour calibration requirement	10 days	Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements