Diabetes Mellitus, Type 1NCT06645834
Smart MDI Study (CIP343)
A study testing Smart MDI System in people with Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 18 sites in 6 countries.
Trial summary
The purpose of the study is to evaluate the effectiveness of the Smart MDI system with InPen™ and Simplera™ in comparison with Multiple Daily Injection (MDI) therapy with intermittent scanning or real-time Continuous Glucose Monitoring (isCGM/CGM) over 6 months duration in people with type 1 diabetes to support the… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Smart MDI System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 6 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is age 2 years or older at time of screening.
- Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥ 6 months prior to screening.
- Subject has a clinical diagnosis of type 1 diabetes for ≥ 12 months.
- Subject is on MDI therapy with intermittent scanning or Continuous Glucose Monitoring (isCGM/CGM) ≥ 3 months prior to screening.
- Subject has high compliance with sensor wear, per investigator assessment.
- Subject has a Glycosylated hemoglobin (HbA1c) ≥ 8% (64 mmol/mol) as assessed locally at time of screening visit.
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- Subject is willing to take or switch to one of the InPen-compatible insulin types, NovoRapid™, Fiasp™, Humalog™ and Lyumjev™.
- Subject or parent(s)/legal guardian(s) has a compatible mobile phone with Internet access.
- Subject or parent(s)/legal guardian(s) is willing and able to provide written informed consent, comply with all study procedures and wear all study devices, as required during the study.
Who cannot join
- Subject is using a Medtronic InPen™ for at least 3 months prior to screening.
- Subject has untreated/unstable Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, untreated coeliac disease, untreated thyroid disorder, or poorly controlled asthma, per investigator judgment.
- Subject is planning to initiate or change to another glucose modifying therapy (for example pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin or SGLT2 inhibitors).
- Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study chronically.
- Subject has renal failure (stage 4 and above) defined by creatinine clearance of \<30 ml/min, as assessed by Local Lab test ≤ 6 months before screening or performed at screening at Local Lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
- Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
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- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
- Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
- Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study.
- Subject is a woman who is breastfeeding.
- Subject or parent(s)/legal guardian(s) is legally incompetent, illiterate or a vulnerable person.
- Subject is a member of the research staff involved with executing the study.
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Belgium4 sites
Antwerp University Hospital
Antwerp
Hospital Universitaire Bruxelles Erasme
Brussels
UZ Leuven
Leuven
CHU Liege
Liège
France4 sites
CHRU de Brest service diabetologie endocrinologie
Brest
Center for DIABeCare, Hospices Civils de Lyon
Lyon
CHU Nimes
Nîmes
Hospital Rangueil
Toulouse
Germany3 sites
Zentrum fur digitale Diabetologie Hamburg
Hamburg
Hannoversche Kinderheilanstalt
Hanover
MVZ Stoffwechselmedizin Leipzig
Leipzig
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg
Uddevalla Hospital
Uddevalla
Hogsbo Narsjukhus
Västra Frölunda
Italy2 sites
University of Bari Aldo Moro
Bari
ASST Spedali Civili Brescia
Brescia
About this study
Official title: Smart MDI Randomized Controlled Trial in Subjects With Type 1 Diabetes (Smart MDI Study)
The purpose of the study is to evaluate the effectiveness of the Smart MDI system with InPen™ and Simplera™ in comparison with Multiple Daily Injection (MDI) therapy with intermittent scanning or real-time Continuous Glucose Monitoring (isCGM/CGM) over 6 months duration in people with type 1 diabetes to support the market access and therapy adoption of the Smart MDI system.
Read the detailed description
This is a post-market, prospective, open-label, multi-center, randomized controlled trial in adult and pediatric subjects with type 1 diabetes.
The study consists of a run-in phase of 3 weeks and a study phase of 6 months.
The purpose of the run-in phase is to collect baseline HbA1c and CGM data while subjects are on their current therapy.
During the 6-month study phase, subjects will be randomized to continue with their current therapy or to start using the Smart MDI system.
Approximately 140 subjects with type 1 diabetes aged 2 years and older will be enrolled in the study at up to 20 investigational centers in Europe to achieve approximately 112 subjects randomized and completing the 6-month study phase.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Smart MDI 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.
Smart MDI SystemDevice
The Smart MDI system consists of the InPen™ system and Simplera™ system.
The InPen™ system includes a reusable smart bolus insulin pen injector with Bluetooth combined with the InPen™ app to help users take insulin doses.
And InPen™ app which communicates with the InPen™ injector and compatible continuous glucose monitoring (CGM) devices to collect and display information on insulin delivered by the injector as well as current and past glucose values.
The Simplera™ system consists of a disposable integrated sensor-transmitter platform (Simplera™ Sensor) and the Simplera™ app which receives data from the Simplera™ sensor via Bluetooth Low Energy (BLE) radio signal
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Subjects will start using the Smart MDI system consisting of the InPen™ System and Simplera™ System. Receives: Device: Smart MDI System |
| Control | No intervention | None -Subjects will continue their own MDI therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The primary endpoint is the between-treatment (Smart MDI system arm vs MDI + isCGM or CGM arm) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L). The endpoint will be assessed for non-inferiority with an absolute margin of 7.5% time in target range.
Measured: 6-month study period
Secondary outcomes (3)
Secondary Endpoint 1
Mean HbA1c at the end of the 6-month study phase, non-inferiority test with an absolute margin of 0.4% HbA1c.
Measured: 6-month study period
Secondary Endpoint 2
% of Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]) during the study phase, simple superiority test.
Measured: 6-month study period
Secondary Endpoint 3
Mean HbA1c at the end of the 6-month study phase, simple superiority test.
Measured: 6-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start6 Dec 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects must successfully complete the run-in phase by demonstrating tolerance to sensor wear and compliance with study procedures prior to being randomized for the study phase, in which subjects will either be using the InPen™ with InPen™ App and Simplera™ system (Treatment Arm = T) or will continue under their MDI therapy with CGM (Control Arm = C) for another 6 months.
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645834
- Sponsor's protocol ID
- CIP343
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart MDI Randomized Controlled Trial in Subjects With Type 1 Diabetes (Smart MDI Study)
- ClinicalTrials.gov ID
- NCT06645834
- Acronym / sponsor ID
- CIP343
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 17 Oct 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 the study is to evaluate the effectiveness of the Smart MDI system with InPen™ and Simplera™ in comparison with Multiple Daily Injection (MDI) therapy with intermittent scanning or real-time Continuous Glucose Monitoring (isCGM/CGM) over 6 months duration in people with type 1 diabetes to support the market access and therapy adoption of the Smart MDI system.
Detailed description
This is a post-market, prospective, open-label, multi-center, randomized controlled trial in adult and pediatric subjects with type 1 diabetes.
The study consists of a run-in phase of 3 weeks and a study phase of 6 months.
The purpose of the run-in phase is to collect baseline HbA1c and CGM data while subjects are on their current therapy.
During the 6-month study phase, subjects will be randomized to continue with their current therapy or to start using the Smart MDI system.
Approximately 140 subjects with type 1 diabetes aged 2 years and older will be enrolled in the study at up to 20 investigational centers in Europe to achieve approximately 112 subjects randomized and completing the 6-month study phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible subjects must successfully complete the run-in phase by demonstrating tolerance to sensor wear and compliance with study procedures prior to being randomized for the study phase, in which subjects will either be using the InPen™ with InPen™ App and Simplera™ system (Treatment Arm = T) or will continue under their MDI therapy with CGM (Control Arm = C) for another 6 months.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: Smart MDI SystemSubjects will start using the Smart MDI system consisting of the InPen™ System and Simplera™ System. |
| Control | No intervention | –None -Subjects will continue their own MDI therapy |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is age 2 years or older at time of screening.
- Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥ 6 months prior to screening.
- Subject has a clinical diagnosis of type 1 diabetes for ≥ 12 months.
- Subject is on MDI therapy with intermittent scanning or Continuous Glucose Monitoring (isCGM/CGM) ≥ 3 months prior to screening.
- Subject has high compliance with sensor wear, per investigator assessment.
Key exclusion criteria (13 listed)
- Subject is using a Medtronic InPen™ for at least 3 months prior to screening.
- Subject has untreated/unstable Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, untreated coeliac disease, untreated thyroid disorder, or poorly controlled asthma, per investigator judgment.
- Subject is planning to initiate or change to another glucose modifying therapy (for example pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin or SGLT2 inhibitors).
- Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study chronically.
- Subject has renal failure (stage 4 and above) defined by creatinine clearance of \<30 ml/min, as assessed by Local Lab test ≤ 6 months before screening or performed at screening at Local Lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
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 |
|---|---|---|
| Smart MDI SystemThe Smart MDI system consists of the InPen™ system and Simplera™ system. The InPen™ system includes a reusable smart bolus insulin pen injector with Bluetooth combined with the InPen™ app to help users take insulin doses. And InPen™ app which communicates with the InPen™ injector and compatible continuous glucose monitoring (CGM) devices to collect and display information on insulin delivered by the injector as well as current and past glucose values. The Simplera™ system consists of a disposable integrated sensor-transmitter platform (Simplera™ Sensor) and the Simplera™ app which receives data from the Simplera™ sensor via Bluetooth Low Energy (BLE) radio signal | Device | Treatment |
Primary outcome
Primary Endpoint
Time frame: 6-month study period
The primary endpoint is the between-treatment (Smart MDI system arm vs MDI + isCGM or CGM arm) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L). The endpoint will be assessed for non-inferiority with an absolute margin of 7.5% time in target range.
3 secondary outcomes
Secondary Endpoint 1
Time frame: 6-month study period
Secondary Endpoint 2
Time frame: 6-month study period
Secondary Endpoint 3
Time frame: 6-month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart MDI System in people with Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 18 sites in 6 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 9 inclusion and 13 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: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Belgium, France, Germany, Sweden, Czechia and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 6-month study period). 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 9 Dec 2025.