Clinical trial NCT02456922: A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
Official title: A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Type 1 Diabetes
Type 2 Diabetes
Harmony 1
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2015-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Harmony 1 Sensor accuracy
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rainier Clinical Research Center
name: Ronald Brazg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diablo Clinical Research
name: Mark Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Davis Center
name: Satish Garg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Davis Center
name: Robert Slover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SoCal Diabetes
name: Kevin Kaiserman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Diabetes Associates
name: Bruce Bode, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Diabetes & Endocrinology
name: Luis Casaubon, MD
role: PRINCIPAL_INVESTIGATOR
References: