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

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Recruitment Status : Withdrawn (For administraive reasons)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

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456922


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
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02456922     History of Changes
Other Study ID Numbers: CEP301
First Posted: May 29, 2015    Key Record Dates
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