Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Type 2 Diabetes, Harmony Sensor, Continuous Glucose Monitoring, CGM
Brief summary
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.
Detailed description
The study is a multi-center, prospective single-sample correlational design without controls.
Interventions
DEVICEHarmony 1 Sensor
Use of Harmony 1 Sensor for 10 days when inserted in the arm and abdomen and used with the Guardian Mobile in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 6 months.
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 14 - 75 years of age at time of screening 2. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis 3. Adequate venous access as assessed by investigator or appropriate staff
Exclusion criteria
1. Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individual. 2. Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection) 3. 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 4. Subject is female and has a positive pregnancy screening test 5. 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 6. Subject is female and plans to become pregnant during the course of the study 7. Subject has had a hypoglycemic seizure within the past 6 months 8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit. 9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit. 10. Subject has a history of a seizure disorder 11. Subject has central nervous system or cardiac disorder resulting in syncope 12. 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 13. Subject has a hematocrit (Hct) lower than the normal reference range 14. Subject has a history of adrenal insufficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour calibration requirement | 10 days | Descriptive summary of sensor accuracy for Harmony 1 Sensor data with the every 24 hour calibration requirements |
Outcome results
None listed