A Feasibility Trial to Evaluate the Senseonics Continuous Glucose Monitoring System
- Conditions
- Health Condition 1: null- Type 1 Diabetes Mellitus
- Registration Number
- CTRI/2013/12/004204
- Lead Sponsor
- Senseonics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 20
1. Age >= 18 to <= 65 years at screening
2. Clinically confirmed diagnosis of Type 1 diabetes mellitus (for at least I 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.
4. HbA1c <= 10%
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.
4. Any condition preventing or complicating the placement, operation or removal of the Sensor.
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.
6. Known microvascular (diabetic) complications (other than non-proliferative retinopathy), including active proliferative diabetic retinopathy or macular edema, non-proliferative retinopathy stage 3, diabetic nephropathy (other than microalbuminuria with normal creatinine), gastroparesis or neuropathy requiring treatment.
7. Currently receiving any of the following therapies, or likely to need such treatment during the follow-up period of this study:
Immunosuppressant therapy
Chemotherapy for any form of cancer
Anti-coagulant therapy (e.g. Plavix, LMW heparin, coumadin)
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 likely to require the use of magnetic resonance imaging (MRI).
16. Positive drug screen results
17. Any condition that in the investigatorâ??s opinion would make the Subject unable to complete the study. Investigator will supply rationale.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method