Translator Android handheld device Insulin pump CGM sensor

Translator
CGM sensor
Android handheld device
Insulin pump
Welcome to the Artificial Pancreas Group
Newsletter for Winter 2014/2015. We have
once again had a busy, exciting and
successful year and we hope you will enjoy
reading about some of our activities.
First we would like to take the opportunity
to express our thanks to the many
volunteers who have given up their time to
help in the studies.
Without you there
would be no research and no progress.
We are truly grateful to you.
We wish you all a healthy and prosperous
year for 2015.
Studies in Young People
We completed an in hospital study with 2-6 year old children
where we looked at glucose control on two overnight visits: one
with diluted insulin
and one visit with standard insulin.
The
diluted insulin was well tolerated by the little children and the
results of the study have been accepted for publication by BMJ
Diabetes Research and Care.
As many of you know, we are now running a study where we are
controlling glucose overnight at home for 3 months using a small
tablet computer. This study will be completed early in 2015 with
children from Leeds, London and Cambridge. The early data
looks promising with improvements in blood glucose levels
(HbA1c) after using closed loop for 3 months overnight.
We have also completed a study where the algorithm was
contained in an android phone. The glucose was controlled by
the phone for 7 days and nights. We are preparing the data
analysis now and we are hoping to have the opportunity to
present this study at the American Diabetes Association later
next year.
Lastly, we are conducting an overnight hospital study testing the
Cambridge algorithm with a Medtronic pump and sensor. So far,
we have studied 4 out of 12 subjects so hopefully will finish this
study early in 2015.
Adult Studies
Earlier this year, we published two closed-loop home studies in
adults (aged 18 years and older) with type 1 diabetes. These
were the first home studies in the world to be performed outside
of the hospital setting where participants were free to perform
their daily activities without the need for supervision or remote
monitoring.
In one study, 24 participants from three UK centres (Cambridge,
London and Sheffield) spent four weeks at home using a closedloop system combined with real-time CGM overnight, and four
weeks using real-time CGM alone. Participants spent a greater
amount of time overnight with glucose levels within the target
range (3.9 and 8.0 mmol/l) during closed-loop, compared to realtime CGM alone. The average glucose levels overnight were
also reduced without causing any further increase in the risk of
hypoglycaemia. Participants were asked how they got on using
the closed-loop system at home and its impact on their quality of
life through questionnaires and telephone interviews.
The
majority were very positive in their experience and feedback,
although there were issues with device reliability and connectivity
which need further improvement.
In the other study, 17 participants from the UK, Austria and
Germany used closed-loop day and night at home for 1-week,
and another week using real-time CGM alone. The proportion of
time spent with normal glucose, within the target range of 3.9 and
10.0 mmol/l, was significantly improved during closed-loop.
Lower average glucose levels without increase in time spent
hypoglycaemic were also achieved during closed-loop, compared
to real-time CGM alone.
In a separate study, an automated closed-loop system prototype
was developed and assessed in the hospital research facility for
one night. Participants' glucose values were in target for 75% of
the time overnight during closed-loop with no hypoglycaemia.
Results from research facility and home studies have thus far
provided encouraging evidence that closed-loop systems may
potentially be able to transform clinical outcome and the quality of
life of people with type 1 diabetes.
Hospital Studies
In people with type 2 diabetes who are on insulin, glucose levels
can be difficult to manage when they are unwell and admitted to
hospital.
A closed-loop system may improve diabetes control
compared with currently used treatments in hospital such as
insulin sliding scales.
We recently started a new study in
Addenbrooke's Hospital, where we recruit patients in the general
wards with insulin-treated type 2 diabetes. In this study they will
be randomly selected, either to receive 3 days of fully automated
closed-loop insulin delivery, or to continue with their usual
diabetes treatments in hospital.
The aim is to compare the
amount of time spent with normal glucose and average glucose
levels in hospital, between the two groups. A total of 40 patients
will be enrolled into the study, and the results will be reported
once the study is completed.
Pregnancy Studies
We have previously tested the closed-loop system in early and
late pregnancy and under stressful conditions including high
carbohydrate meals and exercise in hospital. The system is able
to safely and effectively adapt to the changing conditions of
pregnancy in a hospital setting.
We are currently conducting the first home trials of overnight
closed-loop insulin delivery during pregnancy. In the current
study.
We are aiming to recruit approximately 16 pregnant
women from Addenbrooke’s Hospital Cambridge, Ipswich
Hospital, the Norfolk and Norwich University Hospital and King’s
College London Hospital. In this study, each woman wears the
closed-loop system overnight for 28 nights and the CGM and
pump alone (open loop) for a further 28 nights.
We are
comparing the amount of time women spend with target blood
sugars (3.5-7.8mmol/L) in closed and open loop. We are also
learning about women’s thoughts and feelings about using the
device and the impact that the closed-loop insulin delivery has on
their quality of life.
We are aiming to have results available in the second half of
2015 before starting a study of day and night closed-loop during
pregnancy.
We are also planning a larger clinical trial using
closed-loop throughout pregnancy.
User Group
The User Group continues to meet once or twice a year and
provides invaluable feedback and advice on our studies.
Participants either have diabetes themselves or care for
someone with diabetes, so they have plenty of experience to
help us with the design of studies and the issues our research
should be addressing.
If you are interested in joining this group in the future, please
contact
the
Study
[email protected]
Coordinator
Josephine
Hayes
on
Our future plans
Because of the encouraging results from our studies so far, we
are now ready to conduct larger studies involving more people
from across the UK and in the USA.
The next study which we intend to start in 2015 will test the
closed-loop system combined with a pump suspend feature in
adults and children for a period of three months, day and night in
their own homes.
Eight centres in Britain and America will
participate, each one recruiting between 5 and 20 participants.
From that study we aim to find out whether the system will
improve
glucose
control
and
reduce
the
incidence
of
hypoglycaemia.
Another area which we wish to investigate is the period
immediately following a type 1 diabetes diagnosis in young
people aged between 10 and 18 years. We would like to see
whether the use of the closed-loop system from diagnosis
onwards might help to improve glucose control and reduce
possible complications.
design.
This study is in the early stages of
Our team
Dr Roman Hovorka
Director of Research
Professor David Dunger
Consultant Paediatrician
Dr Mark Evans
Consultant Physician
for Adult Studies
Dr Carlo Acerini
Consultant Paediatrician
Dr Helen Murphy
Consultant Physician
for Pregnancy Studies
Hood Thabit
Study Clinician
Martin Tauschmann
Study Clinician
Zoe Stewart
Study Clinician
Sankalpa Neupane
Study Clinician
Janet Allen
Research Nurse
Marianna Nodale
Research Assistant
Gosia Wilinska
Data Analyst
Sam Goode
Administrative Assistant
Josephine Hayes
Study Coordinator
Yue Ruan
PhD Student
Acknowledgements
The following organisations have kindly supported and
funded our research and made it possible for our work to
continue:
Cambridge
Biomedical Research Centre
National Institute of Health, USA
University of Cambridge
Wellcome Trust-MRC Institute of Metabolic Science
Addenbrooke's Hospital
Metabolic Research Laboratories, Level 4, Box 289
Hills Road, Cambridge CB2 0QQ
For more information on our current or
future studies, please contact one of the
study team
Adult studies
Dr Hood Thabit
Tel: 01223 769074
email: [email protected]
Paediatric studies
Dr Martin Tauschmann
Tel 01223 769066
email: [email protected]
Pregnancy studies
Dr Zoe Stewart
Tel: 01223 769069
email: [email protected]

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