Health Condition 1: null- Type 1 Diabetes Mellitus
Conditions
Interventions
Intervention1: Senseonics Continuous Glucose Monitroing System: The device is continuous glucose monitoring system. It will be implanted in the body for 180 days. It does not need blood draws for gluc
Sponsors
Senseonics Inc
Karmic Labs PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 to 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%
Exclusion criteria
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. 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 9. Potassium 10. Hematocrit >50% or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess accuracy and longevity of the Senseonics CGM System modifications and to assess safety of the Senseonics CGM System during up to 84 days of Sensor use in the clinic and during home useTimepoint: Day 0, 14, 28, 42, 56, 70, 84 and 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 0, 14, 28, 42, 56, 70, 84 and 91 | — |
Countries
India
Contacts
Public ContactDr Vika G Pai
Oyster and Pearls Hospital
Outcome results
None listed