Impact of a built-in insulin calculator feature on diabetes control * Pilot study

Intensive insulin therapy is designed to provide an adequate amount of basal
(long-acting) and bolus (short-acting) insulin to ensure that a patient remains
within their designated blood glucose targets, without frequent hyper and
hypoglycaemic excursions.
In order to achieve these goals, it is important to establish the correct
insulin dose to be taken before each meal. This calculation needs to take into
consideration a number of factors, including blood glucose levels, insulin/CHO
ratio, insulin duration and CHO intake. As a result it is often difficult for
patients to calculate their required dose using manual bolus calculation
methods.
The FreeStyle InsuLinx Blood Glucose Monitoring System, with its built-in
insulin calculator, allows information on insulin/CHO ratio, insulin duration
and target ranges to be set for each patient by the HCP, making the process of
calculating pre-meal insulin doses simpler. This in turn could help to improve
overall glycaemic control.

The objective of this pilot study is to evaluate the impact of the FreeStyle
InsuLinx on glycaemic control.

Following consent, screening and enrolment, subjects will complete a baseline
phase of 14 days. During this time subjects will wear a masked FreeStyle
Navigator to collect continuous glucose data and use the built-in meter to test
their blood glucose (BG). Subjects will also complete a study diary for the
first 5 days of this period, in which they will record their basal insulin,
food intake and how they calculate insulin dosing.
Following this 14 day masked period subjects will visit the clinic where they
will be randomised with stratification by site into one of 2 groups for the
next 59 days.
o The control group (16 subjects) will use a FreeStyle Freedom Lite meter for a
59 day period. For the last 14 days subjects will wear a masked CGM whilst
continuing to use the FreeStyle Freedom Lite meter to monitor BG.
o The intervention group (32 subjects) will use the FreeStyle InsuLinx meter
with the insulin calculator in either Easy or Advanced mode, subject to the
Healthcare Professional*s (HCPs) recommendation. For the last 14 days subjects
will wear a masked CGM, whilst continuing to use the FreeStyle InsuLinx.
For both groups, subjects will complete 3 questionnaires (DTSQ, HFS, + DDS)
prior to any other study activities at baseline (visit 2) and visit 5. During
visit 6 subjects in the intervention group will be required to complete a
FreeStyle InsuLinx user questionnaire. HbA1c will be measured at screening
(visit 1), baseline (visit 2) and visit 6.

Allocation of subjects will be permuted by block randomisation, stafiied by
clinical site. This will ensure a balanced number of subjects are allocated to
each groupacross each site, while maintaining random allocation.

The intervention group will be required to complete a 59 day period (day 15-74)
using FreeStyle Insulinx Blood Glucose Monitoring System with built-in insulin
calculator.

All subjects will be required to:
Visit the study centre 6 times over the study duration of 74 days.
Participate in 2 phone calls from the study nurse or doctor about their progrss
in the study.
Complete 2 x 14 day CGM phases using FreeStyle Navigator
Use the FreeStyle InsuLinx or FreeStyle Freedom Lite for the last 59 days of
the study, including during the second CGM phase.

Risks of using blood glucose meters:

Glucose testing on the FreeStyle InsuLinx and FreeStyle Freedom Lite will
require about 4 drops (less than 1/100 teaspoon) of blood per day (1 drop per
test). The risks are the same as the subjects' current blood glucose testing.
It may hurt when the lancet goes into the skin; this could produce bruising and
a small scar, which could last for several weeks, plus there is a low risk of
infection. There are similar small risks associated with the collection of
blood samples for the laboratory tests, plus dizziness. The amount of blood
taken for this test will be approximately 1 teaspoon.

Risks of using FreeStyle Navigator:
The FreeStyle Navigator System uses a delivery unit that places the sensor * cm
(or 1/5 inch) into the skin. The subject may experience some mild or moderate
symptoms associated with the sensor insertion or the adhesive used to keep the
sensor in place. These include redness, swelling, rash, itching, bruising, pain
and bleeding; there is also a low risk of infection.

During the study subjects will also be asked to complete a 5 day patient diary
during both CGM phases and complete 3 questionnaires about thier diabetes and
treatment at visits 2 and 5.

The benefit of participating in the study is that the subjects may gain a
better understanding of how to manage their blood glucose, and improve control,
therefore minimising risk of future complications.