Type I DiabetesPhoenix CIP347NCT06739811
Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)
A study testing Implantable Insulin Pump System in people with Type I Diabetes, run by Medtronic MiniMed, Inc. at 11 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the clinical performance of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult patients with Type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), and presenting with frequent, otherwise unexplained… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- Implantable Insulin Pump System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 21 Mar 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is aged ≥ 18 years old.
- 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.
- 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.
- 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).
- 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.
- Subject is willing and able to sign and date informed consent, comply with all study procedures as required during the study.
Who cannot join
- 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.
- 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.
- Subject has any known or suspected allergy to insulin or implantable materials of the MIIPS (pump and catheter) as determined by a physician.
- Subject is a woman who is pregnant, or of childbearing potential, or lactating, and 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.
- Subject is vulnerable, legally incompetent or illiterate.
- Residence or planned non-pressurized travel at elevations above 10000 feet/3048 meters (commercial airline travel is acceptable).
Show all 16Show fewer
- Planning to engage in activities requiring a descent greater than or equal to 10 feet/3 meters below sea level.
- Subject has an active infection requiring antibiotic treatment.
- Subject is a person whose body size is not sufficient to accept implantable pump bulk and weight.
- Subject has a life expectancy of less than 9 months.
- Subject has diagnosis of illicit drugs abuse disorder.
- Subject has diagnosis of marijuana abuse disorder.
- Subject has diagnosis of prescription drugs abuse disorder.
- Subject has diagnosis of alcohol abuse disorder.
- Subject who is unwilling or unable to monitor their glucose level or wear a personal continuous glucose monitor.
- Subject who is unwilling or unable to make programming modifications to the pump based on glucose level readings.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
France10 sites, 3 recruiting
- Not yet recruiting
Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33000
Bogdan Catargi, bogdan.catargi@chu-bordeaux.fr
- Not yet recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Sylvia Franc, sylvia.franc@free.fr
- Active, not recruiting
CHU Dijon Bourgogne
Dijon, 21100
- Active, not recruiting
CHU Lille - Hôpital Huriez
Lille, France, 59037
- Active, not recruiting
Hôpital Européen Marseille
Marseille, 13003
- Active, not recruiting
Centre Hospitalier Universitaire De Montpellier
Montpellier, France, 34295
- Not yet recruiting
CHU de Nancy - Hôpital d'Adultes de Brabois
Nancy, France, 54511
Bruno Guerci, b.guerci@chu-nancy.fr
- Active, not recruiting
Hôpital Lariboisière & Fernand-Widal
Paris
- Active, not recruiting
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg
- Active, not recruiting
CHU de Toulouse - Hôpital Rangueil
Toulouse, France, 31059
Netherlands1 site, 1 recruiting
- Recruiting
Isala Zwolle
Zwolle, Netherlands, 8025 AB
Peter Ruben van Dijk, Dr., +31 88 624 5000, p.r.van.dijk@isala.nl
van Dijk, Dr.
About this study
Official title: Phoenix: Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes
The purpose of this study is to evaluate the clinical performance of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult patients with Type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), and presenting with frequent, otherwise unexplained severe hyper- and/or hypoglycemia.
Read the detailed description
This study is a premarket, interventional, prospective, open-label, multi-center study. It consists of a run-in period, a study period, and a continued access period.
Run-in Period: The purpose of the run-in period is to collect CGM baseline data while subjects are on their current therapy.
Study Period: During the 6-month study period, subjects will be implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.
Continued Access Period: Subjects who have completed the entire study period will continue using investigational study devices until those devices are approved for commercial use. Once CE mark is received, the subjects will continue wearing the implanted device.
- Conditions
- Type I Diabetes
- Being tested
- Implantable Insulin Pump System
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Insulin Pump SystemDevice
Medtronic Implantable Insulin Pump System (MIIPS 2020)
| Study group | Role | What they receive |
|---|---|---|
| MIIPS 2020 | Experimental | Subjects implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion. Receives: Device: Implantable Insulin Pump System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refill accuracy of MIIPS 2020
Refill Accuracy= (Total Actual Volume Dispensed)/(Total Theoretical Volume Dispensed) after the last refill cycle
Measured: 6 months
Secondary outcomes (2)
Refill accuracy at each refill visit
Refill accuracy at each refill visit
Measured: 6 months
Percentage of pump with accuracy ratio < 85% prompting NaOH rinse
The percentage of pumps with refill accuracy < 85% prompting NaOH rinse
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start21 Mar 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739811
- Sponsor's protocol ID
- CIP347
- Acronym
- Phoenix CIP347
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phoenix: Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06739811
- Acronym / sponsor ID
- Phoenix CIP347 / CIP347
- Conditions
- Type I Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical performance of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult patients with Type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin therapy (including external pump), and presenting with frequent, otherwise unexplained severe hyper- and/or hypoglycemia.
Detailed description
This study is a premarket, interventional, prospective, open-label, multi-center study. It consists of a run-in period, a study period, and a continued access period.
Run-in Period: The purpose of the run-in period is to collect CGM baseline data while subjects are on their current therapy.
Study Period: During the 6-month study period, subjects will be implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion.
Continued Access Period: Subjects who have completed the entire study period will continue using investigational study devices until those devices are approved for commercial use. Once CE mark is received, the subjects will continue wearing the implanted device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIIPS 2020 | Experimental | Device: Implantable Insulin Pump SystemSubjects implanted with the MIIPS 2020 and treated with intraperitoneal insulin infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is aged ≥ 18 years old.
- 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.
- 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.
- 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).
- 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.
Key exclusion criteria (16 listed)
- 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.
- 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.
- Subject has any known or suspected allergy to insulin or implantable materials of the MIIPS (pump and catheter) as determined by a physician.
- Subject is a woman who is pregnant, or of childbearing potential, or lactating, and 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.
- Subject is vulnerable, legally incompetent or illiterate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Insulin Pump SystemMedtronic Implantable Insulin Pump System (MIIPS 2020) | Device | MIIPS 2020 |
Primary outcome
Refill accuracy of MIIPS 2020
Time frame: 6 months
Refill Accuracy= (Total Actual Volume Dispensed)/(Total Theoretical Volume Dispensed) after the last refill cycle
2 secondary outcomes
Refill accuracy at each refill visit
Time frame: 6 months
Percentage of pump with accuracy ratio < 85% prompting NaOH rinse
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Insulin Pump System in people with Type I Diabetes, run by Medtronic MiniMed, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Fusco (+ 39 02 241371, laura.fusco@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refill accuracy of MIIPS 2020 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.