A Pilot Study to Evaluate the Longevity, Accuracy and Safety of the Senseonics Continuous Glucose Monitoring System
- Conditions
- Diabetesinsulin-dependent diabetes mellitus10018424
- Registration Number
- NL-OMON38939
- Lead Sponsor
- Senseonics, Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 12
1. Males and Females Aged * 18 years of age.
2. Clinically confirmed diagnosis of diabetes mellitus (for at least 1 year of
duration) on multiple daily injections (>2 injections per day) or on insulin
pump therapy.
3. Subject understands study procedures and risks, is willing to comply with
protocol requirements, and has signed an informed consent document.
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 urine 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 Transmitter.
4.2 Any skin condition that may affect Sensor insertion or external Transmitter 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 < 12.0 g/dl, for males < 13.0 g/dl OR
5.1.2 Abnormal red cell indices and iron deficiency.
5.2 History of hepatitis B, hepatitis C or HIV.
5.3 Symptomatic coronary artery disease, unstable angina, myocardial infarction or stroke
within 6 months of screening, uncontrolled hypertension, or congestive heart failure.
5.4 Any seizure disorder.
5.5 History of adrenal insufficiency.
5.6 Significantly impaired hepatic function
5.7 Renal failure, defined as any prior dialysis or an estimated glomerular filtration rate
(eGFR) below 60 mL/min per 1.73 m2 using CKD-EPI formula (Levey et al, 2009)
5.8 History of cardiac arrhythmia
6. Known microvascular (diabetic) complications, including active proliferative diabetic
retinopathy or macular edema, active non-proliferative retinopathy, diabetic nephropathy
including active retinopathy, gastroparesis or neuropathy.
7. Currently receiving any of the following therapies, or likely to need such treatment during
the follow-up period of this study:
7.1 Immunosuppressant therapy
7.2 Chemotherapy for any form of cancer
7.3 Anti-coagulant therapy (e.g. Plavix, LMW heparin, coumadin)
7.4. Chronic systemic glucocorticoids (excluding topical, optical or nasal, but including
inhaled)
7.5. Antibiotic treatment for chronic infection (e.g. osteomyelitis)
8. Magnesium <1.6 mg/dL at screening.
9. Potassium <3.4 mmol/L at screening.
10. Hematocrit >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 allowed.
15. A condition requiring or li
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objectives of this investigation are to assess accuracy and<br /><br>longevity of the Senseonics CGM System modifications during up to 90 days of<br /><br>Sensor use in the clinic and during home use and to monitor safety of the<br /><br>Senseonics CGM System over the first 90 days of Sensor use by<br /><br>measuring the incidence of device-related and procedure-related serious adverse<br /><br>events during the investigation.<br /><br><br /><br>System modifications include evaluating the biocompatible coating<br /><br>configurations of polyethylene glycol diacrylate (PEG) with or without PET and<br /><br>with or without Nylon 66. These coatings are on the outer surface of the<br /><br>Sensor and are designed to improve the accuracy and/or longevity of the System. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives of this investigation are as follows:<br /><br>* To determine other relevant Senseonics CGM System performance measures.<br /><br>* To evaluate the incidence of procedure and device-related adverse events in<br /><br>clinic and home use.<br /><br>* To evaluate the incidence of all adverse events in clinic and home use.</p><br>