InPen User Experience

This study is a multi-center, single arm study in insulin-requiring adult subjects with type 1 diabetes treated with MDI (basal and bolus) therapy.

The total study duration will be approximately 10 weeks long for each participant.

The study consists of a run-in (phase 1) and study phases 2, 3 and 4.

Phase 1:

The purpose of the run-in phase is to collect baseline HbA1c and blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current MDI therapy.

Phase 2:

All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose calculator (InPen™ Diabetes Management App), and will continue their own SMBG, iscCGM or RT-CGM for two weeks.

Phase 3:

Subjects will continue on the InPen and InPen App for another two weeks utilizing the HCP insights gained during the titration follow-up visit.

Phase 4:

All subjects will utilize the InPen™ system consisting of:

• InPen™ and InPen™ Diabetes Management App
• Guardian™ 4 system (RT-CGM)
• Guardian™ 4 sensor
• Guardian™ 4 transmitter
• Guardian™ 4 app

Inclusion criteria

• 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)

Exclusion criteria

• 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 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 legally incompetent, illiterate or vulnerable person.
• Research staff involved with executing the study.