InPenTM User Experience

In patients with insulin dependent diabetes mellitus, glycemic control is
influenced by numerous factors, such as insulin dosage, insulin absorption,
timing, physiological/ lifestyle factors such as exercise, food intake, sleep,
hormones and illness. These factors may contribute to significant variability
in insulin requirements, which makes self-management of diabetes challenging.
For people with diabetes who take insulin, missing an insulin dose may be a
frequent occurrence. Until recently, there has been no objective way to know in
patients on MDI therapy whether they have actually taken a dose. Therefore,
clinicians rely on patient self-reports of insulin administration and must make
changes in the insulin regimen with the presumption that the patient is taking
their insulin as prescribed. This presumption may lead to over or under
treatment, particularly if non-adherence is frequent. Recently, using novel
Bluetooth-enabled insulin pen cap technology, non-adherence to insulin in
patients with type 1 diabetes and type 2 diabetes was recorded for 24% of bolus
insulin administration and 36%of basal insulin administration.
CGM improves a patient*s ability to get rapid and accurate glucose readings,
however patients are still required to make hundreds of decisions a day with
little guidance on what to eat, what to dose, when to dose, and how to manage
activities such as exercise.
The InPen system integrated with real-time CGM (rtCGM) will provide the patient
with intelligent automation, detection, insights, and recommendations that will
enable them to make informed diabetes management decisions.

The purpose of this study is the evaluation of InPen* with InPen* 2.0 app and
Guardian* 4 system in adult patients with type 1 diabetes for the design of a
future study.

This study is a multi-center, single arm, pilot study in 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 subject.
The study consists of a run-in (phase 1) and study phases 2, 3 and 4

Phase 1:
Enrollment (Visit 1) and Screening/Start Run-in (baseline/Visit 2) The purpose
of the run-in phase is to collect data for two weeks while subjects are on
their current MDI therapy. Blinded CGM will be utilized to collect the baseline
CGM data. Baseline Hba1c will also be collected. Subjects will use the devices
below for blinded CGM:
- Guardian* 4 Sensor
- Guardian* Link 3 transmitter

Phase 2 (Visit 3):
All subjects will utilize a smart bolus insulin pen injector (InPen*) and app
with dose calculator (InPen* 2.0 app), and will continue their own
self-monitoring of blood glucose (SMBG), intermittent scanning CGM (iscCGM) or
real-time CGM (rtCGM) for two weeks.

Phase 3 (Visit 4):
Subjects will have an on-site or remote follow-up visit after Phase 2 (4 weeks
from start/baseline). Subjects will continue on the InPen and InPen app for
another two weeks incorporating HCP recommendations during the follow-up visit.
Blinded CGM will be utilized for all subjects.

Phase 4 (Visit 5):
After four weeks of study phase, HbA1c will be collected, all subjects will
stop their own iscCGM or rtCGM and will use the devices below (Visit 5):
- InPen* and InPen* 2.0 app
- Guardian* 4 system
o Guardian* 4 sensor
o Guardian* 4 transmitter
o Guardian* Clinical app

After two weeks on the system subjects will connect with the study center for
an office or remote visit (Visit 6).

All subjects will utilize the InPen* system for four weeks and then exit from
the study (Visit 7). At the study exit at Visit 7, HbA1c is collected.

The data collected in this pilot study has the potential to facilitate the
development and availability of improved Medtronic devices that may provide
significant benefits to patients in the future. In light of this, we believe
that the overall future potential benefits to the general population of
patients with diabetes outweigh any risk to subjects who choose to participate
in the investigation.