Age ≥18 years at screening Clinical diagnosis of T1D for ≥2 years prior to screening On MDI therapy* for ≥2 years prior to screening Subject has been followed and treated by investigator for at least ≥3 months prior to screening and has undergone local educational therapeutic programmes -
Subject is using:
IS-CGM for ≥3 months with daily average of ≥5 scans with sensor readings >70% of time over the previous month prior to screening Or, RT-CGM for≥3 months with a frequency of sensor use >70% of the time over the previous month prior to screening
Glycosylated hemoglobin (HbA1c) of ≥8.0% (64 mmol/mol) at screening Subject is willing to take or switch to Humalog (insulin lispro injection) or Novolog (insulin aspart) Minimum daily insulin requirement of ≥8 units and maximum of 250 units per day Subject is willing to upload data from the study pump and metre (subject must have internet access and computer system that meets the requirements for uploading study pump data at home) Subject is willing and able to provide informed consent comply with all study procedures and wear all study devices, as required during the study
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Untreated Addison’s disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis Use of pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin, SGLT2 inhibitors at screening Renal failure, defined as creatinine clearance <30 mL/min Subject is planning to switch from IS-CGM to RT-CGM during the 6-month study phase History of hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices Women of childbearing potential who are pregnant at screening or plan to become pregnant during the study period Females who are sexually active and able to conceive not using an effective method of contraception and not agreeing to continue using an effective method of contraception for the duration of the study Unresolved adverse skin conditions in the area of sensor placement (eg, psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) Active participation 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 enrolment into the study Current abuse of illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine) Subject has any other disease or condition that may preclude the patient from participating in the study Subject is legally incompetent, illiterate or vulnerable person Research staff involved with the study
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