The objective of this study is to evaluate the insulin delivery of the Medtronic Implantable Insulin Pump System (MIIPS 2020).
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint:
Delivery 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 4 refill cycles.
Secondary outcome
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
Background summary
Section 4.1 Clinical Protocol
Study objective
The objective of this study is to evaluate the insulin delivery of the
Medtronic Implantable Insulin Pump System (MIIPS 2020).
Study design
The study is a premarket, interventional, prospective, open-label, multi-center
study in adult patients with Type 1 diabetes mellitus that cannot be controlled
with subcutaneous insulin (including pump) therapy, presenting with frequent,
otherwise unexplained severe hyper- and/or hypoglycaemia. No control group has
been introduced in the study design because, with the MIIPS 2007
discontinuation, MIIPS 2020 will be the only treatment option for Subjects who
need continuous intraperitoneal insulin infusion (CIPII) .
Additional procedures required per study protocol that are considered out of
standard of care include the following:
• Pregnancy test
• Blinded CGM
• Questionnaires
• SMBG/Ketone collection (only in the Netherlands)
The study will consist of a run-in period, a study period, and a continued
access period.
Run-in Period: During the run-in period, subjects will wear a blinded Medtronic
CGM unless they are unable to. The purpose of the run-in period is to collect
CGM baseline data while subjects are on their current therapy. The run-in
period duration is at least around 3 weeks and may take place up to 12 weeks
prior to implant.
Study Period: During the 6-month study period, subjects will be implanted with
the MIIPS 2020.
Continued Access Period: Subjects who have completed the study period will be
given the opportunity to continue using the investigational study devices until
those devices are approved for commercial use and are commercially available.
The total number of patients to be enrolled at each site does not have any
specific minimum or maximum requirements, as this study is not statistically
powered.
Twenty subjects will complete the study period at up to 12 investigational
centers in France and the Netherlands. There is no min/max enrollment
requirement for each site. There may be an option to extend enrollment up to 40
subjects based on the data collected from the initial 20 subjects.
Once the first 5 subjects have completed up to Visit 5 (45 ± 7 days), of the
study period, an independent Data Monitoring Committee (DMC) will review the
subjects* data. Enrollment of subjects may continue after DMC approval.
Intervention
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 of baseline accuracy of pump delivery, provision of
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 refill, insulin delivery data download
Continued Access Period:
Continued Access visits will take place after the last study period visit
(Visit 8) and according to the programmed refill schedule (i.e., at 45±7day
intervals after Visit 8)
Starting from Visit 9 - Visits 9 to 14
Pump refill, insulin delivery data download, HbA1c collection at Visits 10, 12,
and 14
Visit 15
Pump refill, insulin delivery data download, provision of supplies for blinded
CGM
Visit 16a (V16 - 21 ± 3 days)
Call subjects to start blinded CGM
Visit 16
Confirmation of blinded CGM completion, insulin delivery data download, HbA1c
collection, pump refill
Continued Access Period will continue with pump refills and insulin delivery
data download every 45 ± 7 days (visits 17 and above) and HbA1c collection will
occur at every other visit from visit 18 onward until market approval of the
study device.
Once the study device obtains market approval, a study exit will be completed.
Study burden and risks
The main benefit of this study is that subjects may experience improved glucose
control. With any Insulin Pump System, there is a risk that the pump will
deliver too much or not enough insulin, resulting in hypoglycemia or
hyperglycemia. These risks have been minimized through numerous safety checks
and features as well as patient requirements to test glucose levels frequently.
Additionally, as with any implantable device, there is a risk of infection at
the implant site or erosion of the device through the skin. These risks have
been minimized through pre- and post-surgical care and follow-up by
investigational center staff.
Additionally, MIIPSs are currently used in a very selected group of patients
who cannot achieve stable glucose control despite structured education for
subcutaneous insulin pump use leading to swings in glucose concentrations.
Clinical trials and literature data showed that those patients may benefit from
continuous intraperitoneal insulin infusion in terms of stability of glycaemic
control, reduction of hypoglycaemic events and improved quality of life.
Therefore, it is expected that these potential benefits to this specific
population of subjects outweigh any risk to subjects who choose to participate
in the investigation.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
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
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, 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84906.000.24 |