Smart MDI Study (CIP343) | NCT06645834

NCT06645834

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital		Antwerp			Belgium
Hospital Universitaire Bruxelles Erasme

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases