Diabetes Mellitus
Conditions
Interventions
None listed
Sponsors
Senseonics Inc.
20451 Seneca Meadows Parkway
Germantown, Maryland, 20876
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and Females ≥18 years of age. 2. Clinically confirmed diagnosis of diabetes mellitus for a duration of 1 year and uses insulin therapy for their diabetes management (including subjects on insulin pump therapy).
Exclusion criteria
Exclusion criteria: 1. History of severe hypoglycemia in the last 6 months prior to study start 2. Diabetic ketoacidosis in the past 6 months. 3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition. 4. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint will be evaluated in a test of superiority to a pre-specified performance goal for accuracy. Mean absolute relative difference (MARD) of Sensor readings will be compared with the reference measurements (YSI) at successive 30-days intervals through 180 days post-insertion. for reference glucose values greater than 75 mg/dL (4.2 mmol/L | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean absolute difference for reference glucose values less than 75 mg/dL (4.2 mmol/L). 1.2. Additional accuracy measures during the period of Sensor use – mean absolute difference; median absolute relative difference; agreement as expressed by readings within 20%, 30% and 40% of reference values; trend accuracy measured over time at different glucose rates of change and starting ranges | — |
Contacts
Public ContactCaroll Cummings
Senseonics Inc. 20451 Seneca Meadows Parkway Germantown, Maryland, 20876
Outcome results
None listed