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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02646878
• Other study ID #: CEP310
• Status: Withdrawn
• Phase: N/A
• First received: December 22, 2015
• Last updated: November 16, 2017
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: November 2017
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Harmony 1 Sensor
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour calibration requirement	Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements	10 days