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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.
See Contacts and Locations
Verified May 2017 by Medtronic Diabetes
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT02456922
First received: May 12, 2015
Last updated: May 25, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 2 - 75 years

Condition Intervention
Type 1 Diabetes Type 2 Diabetes Device: Harmony 1 Sensor

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02456922

Contacts
Contact: Smita Barua 818-576-5534 smita.barua@medtronic.com
Contact: Pamela Haworth 818-576-5847 pamela.c.haworth@medtronic.com

Locations
United States, California
AMCR Institute Not yet recruiting
Escondido, California, United States, 92025
Contact: Timothy Bailey, MD       tbailey@amcrinstitute.com   
Contact: Laura Bedolla, CCRC    (760) 466-1523    lbedolla@amcrinstitute.com   
Principal Investigator: Timothy Bailey, MD         
SoCal Diabetes Not yet recruiting
Torrance, California, United States, 90505
Contact: Kevin Kaiserman, MD       kaiserman@socaldiabetes.com   
Contact: Mary Halvorson    (310) 560-8376    halvorson@socaldiabetes.com   
Principal Investigator: Kevin Kaiserman, MD         
Diablo Clinical Research Not yet recruiting
Walnut Creek, California, United States, 92025
Contact: Mark Christiansen, MD       mchristiansen@diabloclinical.com   
Contact: Margie Macarewich    (925) 930-7267    mmacarewich@diabloclinical.com   
Principal Investigator: Mark Christiansen, MD         
United States, Colorado
Barbara Davis Center for Childhood Diabetes Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Robert Slover, MD       robert.slover@ucdenver.edu   
Contact: Maninderpal Sethi, BA    (303)724-6773    Maninderpal.Sethi@ucdenver.edu   
Principal Investigator: Robert Slover, MD         
Barbara Davis Center Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Satish Garg, MD       satish.garg@ucdenver.edu   
Contact: Christie Beatson, MS, RD, CDE    (303) 724-6761    Christie.Beatson@ucdenver.edu   
Principal Investigator: Satish Garg, MD         
United States, Georgia
Atlanta Diabetes Associates Not yet recruiting
Atlanta, Georgia, United States, 30318
Contact: Bruce W Bode, MD FACE       bbode001@aol.com   
Contact: Jennifer Boyd, MMSc, PA-C    (404) 355-4393 ext 850    jboyd@atlantadiabetes.com   
Principal Investigator: Bruce Bode, MD FACE         
United States, Texas
Texas Diabetes & Endocrinology Not yet recruiting
Austin, Texas, United States, 78731
Contact: Luis Casaubon, MD       luis.casaubon@texasdiabetes.com   
Contact: Alison Cooper    (512) 334-3505    acooper@texasdiabetes.com   
Principal Investigator: Luis Casaubon, MD         
United States, Washington
Rainier Clinical Research Center, Inc. Not yet recruiting
Renton, Washington, United States, 98057
Contact: Ronald Brazg, MD       rbrazg@rainier-research.com   
Contact: Kristen Hughes    (425) 251-4021    khughes@rainier-research.com   
Principal Investigator: Ronald Brazg, MD         
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

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT02456922     History of Changes
Other Study ID Numbers: CEP301
Study First Received: May 12, 2015
Last Updated: May 25, 2017
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

ClinicalTrials.gov processed this record on August 18, 2017