VIENNA, February 20, 2018 /PRNewswire/ --
Usage of DexCom CGM
reduced the incidence of hypoglycaemic events by 72%
for high risk individuals with
type 1 diabetes on multiple daily
injections (MDI) of insulin
DexCom, Inc. (Nasdaq: DXCM), has today released the findings of
the HypoDE study, a multi-centre, randomised controlled trial (RCT)
which was discussed on Friday 15th February at ATTD. The
study found that the use of Dexcom continuous glucose monitoring
(CGM) reduces the frequency and severity of hypoglycaemic events
among high-risk individuals with type 1 diabetes treated with
multiple daily injections (MDI) of insulin.
(Logo:
http://mma.prnewswire.com/media/553571/Dexcom_Logo.jpg )
Hypoglycaemia remains a key limiting factor in achieving optimal
glycaemic control in people with type 1 diabetes, and the vast
majority of these individuals are treated with MDI globally. These
results represent a breakthrough for individuals with type 1
diabetes and impaired hypoglycaemia awareness, demonstrating the
potential of Dexcom CGM to help avoid low glucose levels and severe
hypoglycaemic events, which were reduced by over two-thirds in the
study.
During the HypoDE study, participants also achieved a more
stable glucose profile using Dexcom CGM and therefore reduced their
glycaemic variability, a risk factor for hypoglycaemia.
"We looked at individuals with impaired hypoglycaemia awareness
(IHA) and severe hypoglycaemia (SH), high risk groups which have
often been excluded from clinical trials to date," said
Lutz Heinemann, Investigator,
Science Consulting in Diabetes. "We found that the Dexcom CGM
system reduces hypoglycaemic events through the availability of low
glucose alarms and use of trend information, which enables
individuals to proactively respond to falling or near-low glucose
values. This is especially helpful to patients with IHA, or other
patients at night when they are most vulnerable to potentially
dangerous hypoglycaemic events."
The study included 149 randomised participants and was conducted
in three phases: baseline phase, therapy phase and follow-up phase.
141 people participated in the follow-up phase between March 2016 and January
2017.
Primary Outcome
- Incidence of hypoglycaemic events decreased by 72% for
participants in the rtCGM group (incidence rate ratio 0·28, [95% CI
0·20-0·39], p<0·0001).
Secondary Outcomes
- In the Dexcom CGM group, the number of nocturnal hypoglycaemic
events over 28 days was reduced from an average of 2.3 events at
baseline to 1 event at follow-up, versus an increase of 2.4 to 2.7
in the control group.
- Dexcom CGM reduced the rate of SH by approximately 50% when
compared to the control group.
- Dexcom CGM use improved glucose control; the CGM group saw a
reduction in glycaemic variability to 34.1%, from 39.3% at
baseline.
John Lister, General Manager,
Dexcom EMEA, said: "We are committed to enhancing people's quality
of life with CGM technology that provides peace of mind with
real-time, accurate results. We're pleased the findings demonstrate
that usage of Dexcom CGM technology reduces the frequency and
severity of hypoglycaemic events, which can be distressing for the
patient and their family; and can help people to achieve a more
stable blood glucose profile, which can reduce the risk of
associated health complications."
For more information on the study, please visit The Lancet
Journal here:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30297-6/fulltext.
Methodology
The HypoDE study was a multi-centre, randomised, open label
parallel study conducted at 12 diabetes practices in Germany. Eligible participants had type 1
diabetes and a history of impaired hypoglycaemia awareness and/or
severe hypoglycaemia (SH) during the previous year. All
participants wore a blinded rtCGM system (Dexcom G4®
PLATINUM with software 505) for 28 days and were then randomised to
26 weeks of unblinded rtCGM using Dexcom G5 Mobile or
self-monitoring of blood glucose (SMBG). The control group wore a
blinded rtCGM system (Dexcom G4 PLATINUM with software 505) during
the follow-up phase (weeks 22 to 26). The primary outcome was the
difference of low glucose events, defined as spending at least 20
minutes in a glucose range ≤3·0 mmol/L (≤54 mg/dL). The trial is
registered with ClinicalTrials.gov: NCT02671968.
About DexCom, Inc.
Founded in 1999, DexCom, Inc. has corporate offices in
San Diego, California, EMEA
headquarters in Edinburgh,
Scotland and users in 39 countries around the world. At
Dexcom, we are transforming diabetes care and management by
providing superior continuous glucose monitoring (CGM) technology
to help people with type 1 diabetes and healthcare professionals
better manage diabetes. Since our inception, we have focused on
better outcomes for patients, caregivers, and clinicians by
delivering solutions that are best in class-while empowering our
community to take control of diabetes. For more information on
Dexcom CGM, visit www.dexcom.com/global.