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

• ClinicalTrials.gov Identifier: NCT02456922
• Recruitment Status: Withdrawn
• First Posted: May 29, 2015
• Last Update Posted: October 15, 2018
• Sponsor: Medtronic Diabetes
• Information provided by (Responsible Party): Medtronic Diabetes

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes; Type 2 Diabetes	Device: Harmony 1 Sensor	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
• Estimated Study Start Date: July 2018
• Estimated Primary Completion Date: December 2018
• Estimated Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Group A; Subjects wearing Harmony 1 Sensor for up to 10 days.	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Harmony 1 Sensor accuracy [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 75 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Medtronic Diabetes

Investigators

• Principal Investigator: Ronald Brazg, MD; Rainier Clinical Research Center
• Principal Investigator: Mark Christiansen, MD; Diablo Clinical Research
• Principal Investigator: Timothy Bailey, MD; AMCR Institute
• Principal Investigator: Satish Garg, MD; Barbara Davis Center
• Principal Investigator: Robert Slover, MD; Barbara Davis Center
• Principal Investigator: Kevin Kaiserman, MD; SoCal Diabetes
• Principal Investigator: Bruce Bode, MD; Atlanta Diabetes Associates
• Principal Investigator: Luis Casaubon, MD; Texas Diabetes & Endocrinology

More Information

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT02456922
• Other Study ID Numbers: CEP301
• First Posted: May 29, 2015
• Last Update Posted: October 15, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Medtronic Diabetes:

Type 1 Diabetes; Type 2 Diabetes; Harmony 1

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases