insulin-dependent diabetes mellitus Type 1 diabetes
Conditions
Interventions
LET OP VANAF HIER MOET NOG!
Subjects will receive two Sensor insertions during Visit 2 (Day 0). Subjects
will not be required to fast prior to the visit. Vital signs, fingerstick
glucose and &beta
-HOB (&beta
-hydroxybutyrate) levels will be measured. If the subject
is female, a urine HCG test will be performed. If the subject meets in-clinic
visit eligibility criteria, he/she will proceed with two Senso
Sponsors
Senseonics, Incorporated
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Females and males aged >=18 to 2 injections per day) or on insulin pump therapy. 3. HbA1c
Exclusion criteria
Exclusion criteria: Subjects will be denied participation in the investigation if they meet any of the following key, exclusion criteria: 1. History of severe hypoglycemia in the 6 months immediately prior to study start. 2. Severe diabetic Ketoacidosis in the past 6 months. 3. Females who are lactating, pregnant or intending to become pregnant during the course of the investigation, defined as 3.1 Not postmenopausal for at least 1 year OR 3.2 Not surgically sterile, OR 3.3 If of child bearing potential, the subject is not practicing birth control, not willing to avoid pregnancy for the period of study participation, has a positive serum pregnancy test at screening or has a positive urine pregnancy test at the time of the Sensor insertion procedure. 4. Any condition preventing or complicating the placement, operation or removal of the Sensor, including but not limited to: 4.1 Upper extremity deformities that would impede the placement of the Sensor or application of the external Reader. 4.2 Any skin condition that may affect Sensor insertion or external Reader placement. 5. 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 but not limited to: 5.1 Anemia, defined as either: 5.1.1 Hemoglobin (Hgb) value for females of 50% or <30% at screening. 11. Topical or local anesthetic allergy. 12. Known current or recent alcohol or drug abuse by subject history. 13. Participation in another clinical investigation within 30 days preceding screening, or intention to participate in any other clinical investigation during the period of this study. 14. The presence of any other active implanted device, whether turned on or off. Passive implants are
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this investigation is to assess accuracy and longevity of the Senseonics CGM System modifications and to assess safety of the Senseonics CGM System during up to 90days of Sensor use in the clinic and during home use. System modifications include evaluating the biocompatible coatings hydroxyethylmethacrylate (HEMA) and polyethylene glycol diacrylate (PEG) with or without PET. These coatings are on the outer surface of the Sensor and are designed to improve the accuracy and/or longevity of the System. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this investigation are as follows: • To determine other relevant Senseonics CGM System performance measures. • To evaluate the incidence of procedure and device-related adverse events in clinic and home use. • To evaluate the incidence of all adverse events in clinic and home use. | — |
Countries
Netherlands
Outcome results
None listed