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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (For administraive reasons)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

Tracking Information
First Submitted Date  ICMJE May 12, 2015
First Posted Date  ICMJE May 29, 2015
Last Update Posted Date October 15, 2018
Estimated Study Start Date  ICMJE July 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Harmony 1 Sensor accuracy [ Time Frame: 7 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
Official Title  ICMJE A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Type 1 Diabetes
  • Type 2 Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE Group A
Subjects wearing Harmony 1 Sensor for up to 10 days.
Intervention: Device: Harmony 1 Sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 16, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
100
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02456922
Other Study ID Numbers  ICMJE CEP301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Diabetes
Study Sponsor  ICMJE Medtronic Diabetes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Diabetes
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP