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

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ClinicalTrials.gov Identifier: NCT02646878
Recruitment Status : Withdrawn (Business decision)
First Posted : January 6, 2016
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

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

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics
Estimated Study Start Date : January 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Harmony 1 Sensor Group A
Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 90 minutes after sensor insertion.
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.

Harmony 1 Sensor Group B
Subjects wearing Harmony 1 Sensor will be assigned this group which will participate in the in-clinic YSI frequent sample testing 12 hours after sensor insertion.
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.




Primary Outcome Measures :
  1. 24 hour calibration requirement [ Time Frame: 10 days ]
    Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02646878


Sponsors and Collaborators
Medtronic Diabetes
Investigators
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Principal Investigator: Ronald Brazg, MD Rainer Clinical Research Center
Principal Investigator: Mark Christiansen, MD Diablo Clinical Research
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02646878    
Other Study ID Numbers: CEP310
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medtronic Diabetes:
Type 1 Diabetes
Type 2 Diabetes
Harmony Sensor
Continuous Glucose Monitoring
CGM
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases