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

This study is not yet open for participant recruitment.
Verified May 2017 by Medtronic Diabetes
Sponsor:
ClinicalTrials.gov Identifier:
NCT02456922
First Posted: May 29, 2015
Last Update Posted: May 30, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Diabetes
May 12, 2015
May 29, 2015
May 30, 2017
December 2017
December 2018   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT02456922 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 2 - 75 years
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Type 1 Diabetes
  • Type 2 Diabetes
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.
Group A
Subjects wearing Harmony 1 Sensor for up to 10 days.
Intervention: Device: Harmony 1 Sensor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 75 Years   (Child, Adult, Senior)
No
Contact: Smita Barua 818-576-5534 smita.barua@medtronic.com
Contact: Pamela Haworth 818-576-5847 pamela.c.haworth@medtronic.com
United States
 
 
NCT02456922
CEP301
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
Plan to Share IPD: No
Medtronic Diabetes
Medtronic Diabetes
Not Provided
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
Medtronic Diabetes
May 2017

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