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. [1]
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 [2], and how to
manage activities such as exercise.

The InPen* system integrated with real-time CGM (RT-CGM) 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 to evaluate the user experience of InPen* with
InPen Diabetes Management App and Guardian * 4 system in adult patients with
type 1 diabetes for the design of a future pivotal study.

Study Design 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. See
Figure CIP page 12.

Phase 1: Enrollment (Visit 1) and Screening/Start Run-in (baseline/Visit 2) 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. Blinded CGM using the Guardian* Sensor 3 and Guardian* Link 3
transmitter will be utilized to collect the baseline CGM data for all subjects
for two weeks.
Study Phases Phase 2 (Visit 3):
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 (Visit 4):
Subjects will have an on-site or remote follow-up (titration) visit after Phase
2 (4 weeks from start/baseline). Subjects will continue on the InPen and InPen
App for another two weeks utilizing the HCP insights gained during the
titration 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 SMBG, iscCGM or RT-CGM and will use the devices below (Visit 5):
* InPen* and InPen* Diabetes Management App
* Guardian* 4 system (RT-CGM)
o Guardian* 4 sensor
o Guardian* 4 transmitter
o Guardian* 4 app

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

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

Run-In Period: 2 weeks

Visit 1 (Office): Consent only


Visit 2 (Office): Screening/Baseline (including baseline demographics and
HbA1c) and Start Run-In
o Eligibility has been confirmed (Visit 1 and 2 may be combined if eligibility
criteria are met)
o Collect baseline HbA1c
o Dispense study devices and blinded CGM diary
o Start blinded CGM (Guardian* Sensor 3 and Guardian* Link 3 transmitter)

Study Period: 8 weeks
*
Visit 3 (Office): Phase 2, Day 14 after Visit 2 (window of +4 days)
o End blinded CGM
o Collect blinded CGM Diary
o Dispense study devices
o Start InPen and InPen Diabetes Management App (subject*s will replace their
own rapid acting insulin pen for the InPen)
*
Visit 4 (Office/Remote): Phase 3, Day 14 after Visit 3 (window of +4 days)
o Dispense study devices and blinded CGM Diary
o Review Insight Report
o Start blinded CGM (Guardian* Sensor 3 and Guardian* Link 3 transmitter) with
subjects continuing their own SMBG, iscCGM or RT-CGM system
*
Visit 5 (Office): Phase 4, Day 14 after Visit 4 (window of +4 days )
o End blinded CGM
o Collect blinded CGM Diary
o Collect HbA1c
o Continue InPen* with InPen Diabetes Management App and start Guardian* 4
system (subject*s will stop their own SMBG, iscCGM or RT-CGM)

Visit 6 (Remote): Phase 4, Day 14 after Visit 5 (window of +4 days )
o Review Insights Report
*
Visit 7 (Office): End of Study, Day 28 after Visit 5 (window of +4 days)
o Collect HbA1c
o Return study devices

The data collected 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.