Diabetes type 1 MIIPS ( Medtronic implantable insulin pump system Medtronic implantable Insulin pump in patients with diabetes type 1
Conditions
Interventions
Run-In Period: 
Visit 1 (up to 12 weeks before implant) - Office Visit
Screening, informed consent, and blinded CGM initiation 
Visit 2 (V1 +21 ± 3 days) - Office Visit
HbA1c collection, confirmation of blinded CGM completion, questionnaire 
completion, MIIPS 2020 training, schedule of implant 
Study Period: 
Visit 3 (Day 0) - Office Visit
Implant procedure
Visit 4 (Day 15 ± 3 days) Office Visit
Incision healing evaluation, study device management check
Visit 5 (Day 45 ± 7 days)
Pump refill, assessment o
supplies for blinded CGM, insulin delivery data download
Visit 6a (V6 - 21 ± 3 days) 
Call subjects to start blinded CGM
Visit 6 (Day 90 ± 7 days) - 3 months visit
Confirmation of blinded CGMcompletion, HbA1c collection, pump refill, insulin 
delivery data download
Visit 7 (Day 135 ± 7 days)
Pump refill, provision of supplies for blinded CGM, insulin delivery data 
download
Visit 8a (V8 -21 ±3 days) 
Call subjects to start blinded CGM
Visit 8 (Day 180 ± 7 days) - 6 months, end of Study Period 
Confirmation of blinded CGM completion, HbA1C collection, questionnaire 
completion, pump rinse (or stand-alone refill procedure if rinse procedure performed before v8 due to refill accuracy lower than 85%), insulin delivery data download
Continued Access Period:
Continue
(Visit 8) and according to the programmed refill schedule (i.e., at 45±7day 
intervals after Visit 8).
NaOH pump rinse procedure to be performed every 6 months, or earlier, as necessary, based on
Sponsors
Medtronic MiniMed, Inc. ( medtronic)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is aged >= 18 years old. 2. Subject has a clinical diagnosis of Type 1 diabetes for >= 6 months prior to screening as determined via medical record or source documentation by an individual qualified to make a medical diagnosis. 3. Subject with type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), presenting with frequent, otherwise unexplained severe hyper-and/or hypoglycaemia. 4. Subject has access to a reliable support person, defined as an individual who has daily contact with the subject and knows who to contact in the event of an emergency (i.e., caregiver). 5. Subject has the physical and intellectual ability (in the opinion of the study investigator) to operate the MIIP system and to comply with the data reporting requirements of the study. 6. Subject is willing and able to sign and date informed consent, comply with all study procedures as required during the study.
Exclusion criteria
Exclusion criteria: Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device before enrollment into this study, that could impact the outcomes of this study; as per investigator and sponsor judgment. 2. Subject has any other disease or condition that may increase risks during the implant procedure or may preclude the subject from participating in the study, as determined by a physician who is not the principal investigator. 3. Subject has any known or suspected allergy to insulin or implantable materials of the MIIPS (pump and catheter) as determined by a physician. 4. Subject is a woman who is pregnant, or of childbearing potential, or lactating, or who is neither surgically sterile, nor using contraceptives (devices, oral, implanted or other physician-approved contraceptive) or willing to use them, at the time of enrollment. 5. Subject is vulnerable, legally incompetent or illiterate 6. Residence or planned non-pressurized travel at elevations above 10000 feet/3048 meters during the study period (commercial airline travel is acceptable). 7. Planning to engage in activities requiring a descent greater than or equal to 10 feet/3 meters below sea level. 8. Subject has an active infection requiring antibiotic treatment. 9. Subject is a person whose body size is not sufficient to accept implantable pump bulk and weight. 10. Subject has a life expectancy of less than 9 months. 11. Subject has diagnosis of illicit drugs abuse disorder. 12. Subject has diagnosis of marijuana abuse disorder. 13. Subject has diagnosis of prescription drugs abuse disorder. 14. Subject has diagnosis of alcohol abuse disorder. 15. Subject who is unwilling or unable to monitor their glucose level or wear a personal continuous glucose monitor. 16. Subject who is unwilling or unable to make programming modifications to the pump based on glucose level readings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Refill accuracy is critical to MIIPS 2020. For each subject*s pump refill, the total actual volume dispensed will be compared to the total calculated volume dispensed to compute the refill accuracy per subject: Refill Accuracy= (Total Actual Volume Dispensed) __________________________________________________________ Total Theoretical Volume Dispensed where the total actual volume dispensed by the pump will be determined by subtracting the insulin weight removed from the pump at the start of a refill procedure from the insulin weight placed in the pump during the previous refill procedure. The theoretical volume dispensed by the pump will be calculated by the Clinician Controller. Refill accuracy will be assessed after the last refill cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety data associated with diabetes management, specifically in the subject population indicated to MIIPS, will be summarized: • Serious Adverse Events (SAE) • Serious Adverse Device Effects (SADE) • Unanticipated Serious Adverse Device Effect (USADE) • Incidence of Severe Hypoglycemia • Incidence of Severe Hyperglycemia • Incidence of Diabetic Ketoacidosis (DKA) The following secondary endpoint will also be calculated to evaluate the insulin delivery of MIIPS 2020: • Refill accuracy at each refill visit • Percentage of pump with accuracy ratio < 85% prompting NaOH rinse procedures at each refill visit | — |
Countries
France, Netherlands
Contacts
Public ContactW.B.C. Mattheussens
Qserve Clinical Services B.V
Outcome results
None listed