Automated insulin delivery for young children with diabetes via Android
app
International clinical trial shows life-changing positive effects for
children and their families

Date:
January 26, 2022
Source:
Universita"t Leipzig
Summary:
Families with young children who have type 1 diabetes use insulin
pumps that require a lot of effort to operate. Scientists have
shown in a clinical trial that automated insulin delivery is safe
and effective even at the age of one to seven years.



FULL STORY ========================================================================== Families with young children who have type 1 diabetes use insulin pumps
that require a lot of effort to operate. Scientists from all over Europe, including researchers from Leipzig University Hospital, the only site
involved in Germany, have shown for the first time in a clinical trial
that automated insulin delivery is safe and effective even at the age
of one to seven years.

The data was recently published in the journal New England Journal
of Medicine.


========================================================================== Managing insulin-dependent diabetes in young children is a major
challenge. In Germany, people mostly use insulin pumps for controlling
blood glucose levels.

In combination with continuous glucose monitoring under the skin, this
is called sensor-augmented pump therapy. The parents are responsible
for manually dosing the insulin and adjusting the elevated blood
glucose. This often requires correction, especially at night. Automated
insulin delivery systems are available for older children and adolescents,
but not for young children.

This age group has the highest day-to-day variability in terms of insulin requirements and cannot respond independently to blood glucose. Prolonged periods of elevated blood glucose levels can have a negative impact on
brain development and intelligence quotient.

An automated insulin delivery system developed at the University of
Cambridge has now been tested on 74 children aged one to seven years
and their families from seven paediatric diabetes centres in the UK,
Austria, Luxembourg and Germany. Leipzig University Hospital was the
only German site involved in the international consortium. Professor
Roman Hovorka from the University of Cambridge has developed an Android
app -- CamAPS FX -- for managing blood glucose levels in young children
with type 1 diabetes, which automatically adjusts the insulin dose when combined with an insulin pump and continuous glucose monitoring.

More effective than standard therapy for young children The approach
employs a so-called hybrid closed-loop system, in which the parents still
have to deliver insulin at mealtimes, but at all other times the algorithm automatically controls the amount of insulin depending on the child's
glucose levels. According to the study data, the system was safe and
more effective than the standard therapy used in this age group. Parents reported finally being able to sleep through the night again without
having to react to elevated or low blood sugar levels. During the night,
blood glucose levels remained in the target area for more than 80 per
cent of the time.

PD Dr. med. Thomas Kapellen, head of this study at the diabetes centre
at Leipzig University Hospital's paediatrics department, examined ten
children aged four to seven years. "Nine of them are continuing to use
the system after the end of the large-scale study, currently as part of
a follow-up observation in real life," said the paediatric diabetologist.

Two hours per day more than before in the desired blood sugar range All
74 young children who took part in the study used the sensor-augmented
mode -- the previous standard therapy -- for 16 weeks, and then the
automated hybrid closed-loop system for 16 weeks. When using the CamAPS
FX app, their blood sugar was in the target range for almost three
quarters of the day. In total, this amounted to 125 minutes longer per
day than with the previous standard therapy. This meant that the study participants spent less than a quarter of the day, 22.9 per cent, above
the blood glucose target range. In contrast, there was no difference
in hypoglycaemia between the two groups. The app also reduced the mean
blood glucose level. When using the new system, the children's metabolic control was thus significantly improved and within the desired range.

"The app is CE-certified, but at present is not yet covered by health
insurance in Germany. Since it is currently the only CE-certified system
in the world for children aged one year and up, I hope that it will be
approved very soon and the costs then covered by the health insurance
funds in Germany," said Dr Thomas Kapellen.

========================================================================== Story Source: Materials provided by Universita"t_Leipzig. Note: Content
may be edited for style and length.


========================================================================== Journal Reference:
1. Julia Ware, Janet M. Allen, Charlotte K. Boughton, Malgorzata E.

Wilinska, Sara Hartnell, Ajay Thankamony, Carine de Beaufort,
Ulrike Schierloh, Elke Fro"hlich-Reiterer, Julia K. Mader, Thomas
M. Kapellen, Birgit Rami-Merhar, Martin Tauschmann, Katrin Nagl,
Sabine E. Hofer, Fiona M. Campbell, James Yong, Korey K. Hood,
Julia Lawton, Stephane Roze, Judy Sibayan, Laura E. Bocchino,
Craig Kollman, Roman Hovorka.

Randomized Trial of Closed-Loop Control in Very Young Children
with Type 1 Diabetes. New England Journal of Medicine, 2022; 386
(3): 209 DOI: 10.1056/NEJMoa2111673 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2022/01/220126144158.htm

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