Smart MDI Study (CIP343)

Inclusion Criteria:

1. Subject is age 2 years or older at time of screening.

2. Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on abasal/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 GlucoseMonitoring (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 locallyat 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 Internetaccess.

9. Subject or parent(s)/legal guardian(s) is willing and able to provide writteninformed consent, comply with all study procedures and wear all study devices, asrequired during the study.

Exclusion Criteria:

1. Subject is using a Medtronic InPen™ for at least 3 months prior to screening.

2. Subject has untreated/unstable Addison's disease, growth hormone deficiency,hypopituitarism or definite gastroparesis, untreated coeliac disease, untreatedthyroid disorder, or poorly controlled asthma, per investigator judgment.

3. Subject is planning to initiate or change to another glucose modifying therapy (forexample pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin or SGLT2inhibitors).

4. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8weeks from time of screening visit, or plans to take any oral, injectable, or IVglucocorticoids 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 orperformed 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 devicein 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 fromparticipating in the study, per investigator judgment.

10. Subject is a woman of child-bearing potential who has a positive pregnancy test atscreening 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 avulnerable person.

13. Subject is a member of the research staff involved with executing the study.