UAE Ministry of Health and Prevention (MoHAP) - UAE Actiste User Experience Pilot

Participation Information Sheet

Introduction

The Actiste Device Management Service (ADMS) provides help to persons with diabetes to
effectively manage their blood glucose levels in an optimal way. ADMS combines an all-in-one
unified and integrated diabetes self-management service which includes the Actiste Device
(providing the functions of a glucometer and an insulin pen to be used in conjunction with
associated consumables) and a smartphone App for sharing of data and information. Thanks
to immediate transfer of digital data through ADMS it gives your healthcare provider the
possibility to access your real-time blood glucose levels and the number of insulin injections
and dosages over time. This enables continual data monitoring with opportunities for
improved diabetes management and proactive action from your healthcare provider when
needed.

The Actiste Device is a unified diabetes self-management device, designed and developed on
Brighter’s extensive and unique Intellectual Property. The Actiste Device reduces the number
of steps required to administer insulin by 67%, with all the functions – lancet, blood glucose
monitor, insulin pen and log – integrated into one device. The Actiste Device integrates 10 test
strips for blood glucose monitoring, a compartment for needles and lancets while
automatically logging time stamped blood glucose values and actual injected insulin
volumes. Data sharing is guaranteed through an embedded, permanently connected global
mobile communication module for independent and secure transfer of the logged data to The
Benefit Loop.

Purpose of the study

• The primary aims of the study are to demonstrate: (1) that ADMS is an effective tool
for persons managing diabetes treated with insulin and who are living in the UAE; and
(2) that persons managing diabetes (and their health care providers) are of the view
that ADMS is feasible and acceptable to them.

• The evaluation of the Participants perspective will be undertaken through a survey at

the beginning and the end of the study which will focus on their experience with using
ADMS, clinical effectiveness and impact on diabetes management (glucose control
and compliance).

• The secondary aims of the study are to evaluate the importance of this new
technology service from a MoHaP and national strategic perspective using
questionnaires.

• We want the feedback of Participants who are diabetic on the functionality and user-
friendliness of the Actiste Device and the supporting services, the quality of service
provided by our customer service team.

• We want the feedback of Participants who are health care providers on the
practicality of ADMS in monitoring their patient's diabetes management and the
quality of service provided by our customer service team.
Patient Participants targeted for study

• Persons Age >18 – 65 years.

• Persons with Type 2 diabetes treated with insulin manufactured by Sanofi basal
insulin ± oral hypoglycaemic agents.

• Persons who are familiar with using Self-Monitoring of Blood Glucose devices.

• Persons who have the ability to read and comprehend the questionnaire in Arabic or
English, according to judgement by the diabetes nurse or the treating physician.

• Persons who have access to and know how to use a smartphone (iOS or Android) and
has the ability to use ADMS properly from a technical perspective

Participants invited to participate In the study

Participants who are healthcare providers will be invited to participate in the study from
MoHAP/Brighter. Such healthcare providers will thereafter select suitable patient participants
to participate in the study from their patients.

Method of Study

• The Participant will be asked to use ADMS for 3 months.

• Before and after the study period they will be asked to answer questions related to
their experiences of conventional diabetes management compared to ADMS.

Expected side effects of the study

The study does not include a specific drug experience and does not interfere with the
treatment prescribed for any Participant by his treating team and therefore there are no
expected complications for the study.

Personal data of Participants involved in the study

Please note that the data collected will remain confidential and will be used for statistical and
educational purposes and for internal analysis only by MoHAP and Brighter. The data will not
be used for any other purpose. Your privacy will be maintained and respected in all presented
results.

Patient Participants

If you are a patient of a health care provider and you decide not to take part in the Actiste
User Experience Pilot, this will not affect your diabetes management care plan in any way.