A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
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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. |
| ClinicalTrials.gov Identifier: NCT02456922 |
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Recruitment Status :
Not yet recruiting
First Posted : May 29, 2015
Last Update Posted : January 16, 2018
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Sponsor:
Medtronic Diabetes
Information provided by (Responsible Party):
Medtronic Diabetes
- Study Details
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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 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Children's Health
| Arm | Intervention/treatment |
|---|---|
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Group A
Subjects wearing Harmony 1 Sensor for up to 10 days.
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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. |
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.
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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
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
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 |
| 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: | January 16, 2018 |
| Last Verified: | January 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:
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Type 1 Diabetes Type 2 Diabetes Harmony 1 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |