Smart MDI Study (CIP343)

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.

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.