RESPONSE TO COMMENT ON LITTLE ET AL.
Recovery of Hypoglycemia Awareness in
Long-standing Type 1 Diabetes: A
Multicenter 2 3 2 Factorial Randomized
Controlled Trial Comparing Insulin Pump
With Multiple Daily Injections and
Continuous With Conventional Glucose
Self-monitoring (HypoCOMPaSS).
Diabetes Care 2014;37:2114–2122
Diabetes Care 2014;37:e272–e273 | DOI: 10.2337/dc14-1947
We agree with Edelman (1) that the
HypoCOMPaSS protocol (2) does not re-
flect current routine clinical practice. It
was not our intention to replicate existing
suboptimal clinical practice with regard
to conventional multiple daily injection
(MDI) therapy and self-monitoring of
blood glucose (SMBG). Rather, the prem-
ise of our study focused on achievability
within routine care. We do not agree
that education, weekly telephone con-
tact, and monthly visits (as part of a tar-
geted 6-month intervention for those
with impaired awareness of hypogly-
cemia [IAH]) should be dismissed as
unachievable. We have shown the po-
tential for a .10-fold reduction in severe
hypoglycemia (SH)dincluding in those
patients not receiving more costly tech-
nological interventions (2). Moreover,
given increasing availability of bolus cal-
culators on both handheld glucometers
and cell phone apps, there is no reason
why access should be limited to those
using continuous subcutaneous insulin
infusion (CSII) or real-time continuous
glucose monitoring (RT-CGM).
Edelman highlights our intent to pro-
vide comparable education and support,
but emphasizes that “device and glu-
cose management education should dif-
fer for different devices” (1). This was
indeed the case, as detailed in our initial
protocol publication (3). Participants
randomized to CSII or RT-CGM attended
specific training sessions tailored to safe
and effective use, while those random-
ized to MDI or SMBG attended compa-
rable but distinct sessions also focused
on optimized use. All participants were
provided with clear and specific insulin
titration protocols, previously reported
in detail (3).
We question the assertion that there
was “lack of glycemic benefit observed
in the subjects who used pumps and
CGM” (1), as our goal was active insulin
titration to avoid biochemical hypogly-
cemia without worsening overall glyce-
mic control. This was rapidly achieved in
all groups within the first 4 weeks and
maintained throughout the randomized
controlled trial (2).
We accept that “consistency of use of
the CGM device is a known key determi-
nant for clinical benefit” (1) but do not
agree that there was lack of clinical ben-
efit in our study. RT-CGM was successful
in improving IAH and preventing SH, and
we observed that comparable benefits
could be accrued from optimized SMBG.
Of particular interest, although those
using RT-CGM for .50% of the time ap-
peared more successful in avoiding bio-
chemical hypoglycemia and achieving
best overall glycemic control, this did
not translate to greater improvement
in IAH and SH in this very high-risk
group.
1
Institute of Cellular Medicine, Newcastle University, Newcastle, U.K.
2
Wellcome Trust-MRC Institute of Metabolic Science Metabolic Research Laboratories, University of Cambridge, Cambridge, U.K.
3
School of Medicine and Biomedical Sciences, Sheffield University, Sheffield, U.K.
4
Peninsula College of Medicine and Dentistry, Plymouth, U.K.
5
Bournemouth Diabetes and Endocrine Centre, Royal Bournemouth Hospital, Bournemouth, U.K.
6
Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, Newcastle, U.K.
7
AHP Research, Hornchurch, U.K.
8
The Australian Centre for Behavioural Research in Diabetes, Diabetes AustraliadVic, Melbourne, Australia
9
Centre for Mental Health and Wellbeing Research, School of Psychology, Deakin University, Burwood, Australia
10
Centre for Postgraduate Medical Research and Education, Bournemouth University, Bournemouth, U.K.
Corresponding author: James A.M. Shaw, jim.shaw@ncl.ac.uk.
© 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit,
and the work is not altered.
Stuart A. Little,
1
Lalantha Leelarathna,
2
Emma Walkinshaw,
3
Horng Kai Tan,
4
Olivia Chapple,
5
Alexandra
Lubina-Solomon,
3
Thomas J. Chadwick,
6
Shalleen Barendse,
7
Deborah D. Stocken,
6
Catherine Brennand,
6
Sally M. Marshall,
1
Ruth Wood,
6
Jane Speight,
7,8,9
David Kerr,
10
Daniel Flanagan,
4
Simon R. Heller,
3
Mark L. Evans,
2
and James A.M. Shaw
1
e272 Diabetes Care Volume 37, December 2014
e-LETTERS – COMMENTS AND RESPONSES