Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
179 participants
INTERVENTIONAL
2024-12-06
2025-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Subjects will start using the Smart MDI system consisting of the InPen™ System and Simplera™ System.
Smart MDI System
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
Control
None -Subjects will continue their own MDI therapy
No interventions assigned to this group
Interventions
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Smart MDI System
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
Eligibility Criteria
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Inclusion Criteria
2. Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥ 6 months prior to screening.
3. Subject has a clinical diagnosis of type 1 diabetes for ≥ 12 months.
4. Subject is on MDI therapy with intermittent scanning or Continuous Glucose Monitoring (isCGM/CGM) ≥ 3 months prior to screening.
5. Subject has high compliance with sensor wear, per investigator assessment.
6. Subject has a Glycosylated hemoglobin (HbA1c) ≥ 8% (64 mmol/mol) as assessed locally at time of screening visit.
7. Subject is willing to take or switch to one of the InPen-compatible insulin types, NovoRapid™, Fiasp™, Humalog™ and Lyumjev™.
8. Subject or parent(s)/legal guardian(s) has a compatible mobile phone with Internet access.
9. 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.
Exclusion Criteria
2. 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.
3. 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).
4. 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.
5. 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.
6. Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
7. 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.
8. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
9. Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
10. 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.
11. Subject is a woman who is breastfeeding.
12. Subject or parent(s)/legal guardian(s) is legally incompetent, illiterate or a vulnerable person.
13. Subject is a member of the research staff involved with executing the study.
2 Years
ALL
No
Sponsors
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Medtronic Diabetes
INDUSTRY
Responsible Party
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Locations
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Antwerp University Hospital
Antwerp, , Belgium
Hospital Universitaire Bruxelles Erasme
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
CHU Liege
Liège, , Belgium
General University Hospital
Prague, , Czechia
IKEM
Prague, , Czechia
CHRU de Brest service diabetologie endocrinologie
Brest, , France
Center for DIABeCare, Hospices Civils de Lyon
Lyon, , France
CHU Nimes
Nîmes, , France
Hospital Rangueil
Toulouse, , France
Zentrum fur digitale Diabetologie Hamburg
Hamburg, , Germany
Hannoversche Kinderheilanstalt
Hanover, , Germany
MVZ Stoffwechselmedizin Leipzig
Leipzig, , Germany
University of Bari Aldo Moro
Bari, , Italy
ASST Spedali Civili Brescia
Brescia, , Italy
Sahlgrenska University Hospital
Gothenburg, , Sweden
Uddevalla Hospital
Uddevalla, , Sweden
Hogsbo Narsjukhus
Västra Frölunda, , Sweden
Countries
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Other Identifiers
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CIP343
Identifier Type: -
Identifier Source: org_study_id
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