Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study

This is an interventional treatment trial for Type1diabetes focused on measuring Pump therapy, Multiple Daily Injections (MDI), Decision Support System (DSS) Read More

Inclusion Criteria:

1. The subject has documented Type 1 Diabetes Mellitus, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 3 months prior to study enrolment ( Part A of the study) or at least 6 months (Part B of the study)
2. Insulin dose requirement is equal or above 0.5/unit/kg
3. The subject age is ≥ 6 years and below 30 years at the time of enrolment
4. A1c < 10%
5. The subject uses multiple daily injections to deliver insulin and wish to switch to pump therapy (Part A of the study) or the subject uses pump therapy for at least 3 months and is willing to switch to multiple daily injections for the study period (Part B of the study)
6. The subject is willing to follow study instructions
7. Subject is available for entire study duration

Exclusion Criteria:

1. Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety, or that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency).
2. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or paraenteral glucocorticoids up to 7 days
3. Subject has known allergy to medical grade adhesives
4. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or receipt of any investigational medical product within 1 month prior to screening (visit1)
5. Female subject of child-bearing potential who have a positive pregnancy test at screening, is pregnant, breast-feeding, or planning to become pregnant within the planned study duration (or is not using adequate contraceptive methods)
6. Subject diagnosed with current eating disorder such as anorexia or bulimia
7. Subject has a history of one or more episodes of Diabetes Keto-acidosis requiring hospitalization within a 3 months prior to screening
8. Subject has visual impairment or hearing loss, which in the Investigator's opinion, may compromise patient ability to perform study procedures safely (child and parent should be evaluated as a unit)