Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
Type 1 Diabetes, Type 2 Diabetes, Harmony 1
Brief summary
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 2 - 75 years
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.
Interventions
DEVICEHarmony 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.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harmony 1 Sensor accuracy | 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. |
Outcome results
None listed