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

NCT ID: NCT02456922

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2018-12-31

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

Subjects wearing Harmony 1 Sensor for up to 10 days.

Group Type: OTHER

Harmony 1 Sensor

Intervention Type: DEVICE

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.

Interventions

Harmony 1 Sensor

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Brazg, MD

Role: PRINCIPAL_INVESTIGATOR

Rainier Clinical Research Center

Mark Christiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Diablo Clinical Research

Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Satish Garg, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Davis Center

Robert Slover, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Davis Center

Kevin Kaiserman, MD

Role: PRINCIPAL_INVESTIGATOR

SoCal Diabetes

Bruce Bode, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta Diabetes Associates

Luis Casaubon, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Diabetes & Endocrinology

Other Identifiers

CEP301

Identifier Type: -

Identifier Source: org_study_id