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Withdrawn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 : September 29, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Type 2 Diabetes | Device: Harmony 1 Sensor | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
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. |
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Other Study ID Numbers: |
CEP301 |
First Posted: | May 29, 2015 Key Record Dates |
Last Update Posted: | September 29, 2020 |
Last Verified: | September 2020 |
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 |
Type 1 Diabetes Type 2 Diabetes Harmony 1 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |