Smart MDI Study (CIP343)

NCT06645834 | Completed FDA Device

• 1 other identifier: CIP343
• Study Type: interventional
• Target: 179
• Locations: 6 countries
• Sites: 18

Brief 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 market access and therapy adoption of the Smart MDI system.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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.

  6-month study period

Secondary Outcomes (3)

• Secondary Endpoint 1

  6-month study period

• Secondary Endpoint 2

  6-month study period

• Secondary Endpoint 3

  6-month study period

Study Arms (2)

Treatment

OTHER

Subjects will start using the Smart MDI system consisting of the InPen™ System and Simplera™ System.

Device: Smart MDI System

Control

NO INTERVENTION

None -Subjects will continue their own MDI therapy

Interventions

Smart MDI System DEVICE

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

Treatment

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (18)

Antwerp University Hospital

Antwerp, Belgium

Location

Hospital Universitaire Bruxelles Erasme

Brussels, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHU Liege

Liège, Belgium

Location

General University Hospital

Prague, Czechia

Location

IKEM

Prague, Czechia

Location

CHRU de Brest service diabetologie endocrinologie

Brest, France

Location

Center for DIABeCare, Hospices Civils de Lyon

Lyon, France

Location

CHU Nimes

Nîmes, France

Location

Hospital Rangueil

Toulouse, France

Location

Zentrum fur digitale Diabetologie Hamburg

Hamburg, Germany

Location

Hannoversche Kinderheilanstalt

Hanover, Germany

Location

MVZ Stoffwechselmedizin Leipzig

Leipzig, Germany

Location

University of Bari Aldo Moro

Bari, Italy

Location

ASST Spedali Civili Brescia

Brescia, Italy

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Uddevalla Hospital

Uddevalla, Sweden

Location

Hogsbo Narsjukhus

Västra Frölunda, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not Applicable, No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: December 6, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); FR (4); CZ (2); DE (3); BE (4); SE (3)