InPen User Experience

Korábbi kezelés

• 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.

Más betegség

• Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.

Egyéb

• Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
• Women who are breastfeeding.
• Subject is legally incompetent, illiterate or vulnerable person.
• Research staff involved with executing the study.

• Subject is aged 18-75 years at time of screening
• Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥1 year prior to screening
• Subject has a clinical diagnosis of type 1 diabetes for 1 year prior to screening
• Subject has a Glycosylated hemoglobin (HbA1c) less than 10% as assessed by local lab \<15 days prior to screening or at time of screening visit
• Subject is on MDI therapy with
  • SMBG,
  • Continuous Glucose Monitoring (CGM), or
  • Intermittent Scanning CGM (iscCGM)
• Subject is willing to upload data from a BG meter, must have internet access and a compatible computer system that meets the requirements for uploading data at home.
• Subject is willing and able to sign and date informed consent, comply with all study procedures, and wear all study devices, as required during the study.
• Subject is willing to take or switch to one of the following insulins:
  • Humalog™\* (insulin lispro injection)
  • NovoLog™\* (insulin aspart)