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                    <p class="art-type" id="articleinfo">Research Article</p>
		    <p class="art-title">Substantial and Sustained HbA1c reductions in Australian Insulin Pump Services for Adults with Type 1 Diabetes. Benefit also evident for Older and High HbA1c Subjects</p>
		    <p class="art-author"><?php $authors="Daniel A Calandro<sup>1,2*</sup>, Andrzej S Januszewski<sup>1,2*</sup>, Kaya K Cuper<sup>2,3</sup>, Marilyn Burgess<sup>2</sup>, Jodie Horsburgh<sup>2</sup>, Margaret Loh<sup>4</sup>, Kathleen  Steele<sup>4</sup>,  Elizabeth  Mulrooney<sup>4</sup>, Fiona Weedon<sup>5</sup>, Brenda Cayzer<sup>5</sup>, Balasubramanian  Krishnamurthy<sup>4</sup>, Richard J MacIsaac<sup>2,4</sup>, Glenn M Ward<sup>2,4</sup>, David N O'Neal<sup>2,4,5</sup>and Alicia J Jenkins<sup>1,2,4</sup>"; echo (stristr($authors,$coauthor))?str_replace($coauthor,"<a href='".$extpath."authors/".$courl."' target='_blank'>".$coauthor."</a>",$authors):$authors; ?></p>
<p class="art-affl"><sup>1</sup>NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia<br/>
			<sup>2</sup>Department of Medicine, University of Melbourne, Fitzroy, VIC, Australia<br/>
			<sup>3</sup>Lake Forest College, Lake Forest, IL, USA<br/>
			<sup>4</sup>Department of Endocrinology and Diabetes, St Vincent's Hospital, Melbourne, VIC, Australia<br/>
			<sup>5</sup>Mercy Hospital, Werribee, VIC, Australia</p>
		    <p class="art-aff"><b>*Corresponding authors: <?php $corresponding_author="Daniel A Calandro"; echo ($coauthor!="" && $coauthor==$corresponding_author)?"<a href='".$extpath."authors/".$courl."' target='_blank'>".$coauthor."</a>":$corresponding_author;?></b>, NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia,<br/>
<b>Andrzej S Januszewski</b>, Department of Medicine, University of Melbourne, Fitzroy, VIC, Australia

E-mail: <a href="mailto:andrzej.januszewski@ctc.usyd.edu.au">andrzej.januszewski@ctc.usyd.edu.au</a></p>
<p class="art-aff"><b>Received:</b>  August 28, 2016
<b>Accepted:</b>   October 17, 2016
<b>Published:</b> October 21, 2016</p>
<p class="art-aff"><b>Citation:</b> Calandro  DA,  Januszewski  AS,  Cuper KK, et al. Substantial and Sustained HbA1c reductions in Australian Insulin Pump Services  for  Adults  with  Type  1  Diabetes.  Benefit  also  evident  for  Older  and  High  HbA1c Subjects. <i>Madridge J Diabetes</i>. 2016; 1(1): 23-28.doi: <a href="https://doi.org/10.18689/mjd-1000104">10.18689/mjd-1000104</a></p>
 
<p class="art-aff"><b>Copyright:</b> &copy;   2016 The Author(s). This work is  licensed  under  a  Creative  Commons  Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p>
<p><a href="<?php echo $extpath;?><?php echo $jres['journal_link'];?>/mjd-1000104.pdf" class="btn btn-danger pull-right" target="_blank">Download PDF</a></p>
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<div class="articlecontent">
<p class="art-para"><b>Keywords:</b> HBA1c; Type 1 Diabetes; Insulin Pump; Exogenous Insulin.</p>
<p class="art-subhead" id="intro">Introduction</p>
<p class="art-para">People with Type 1 diabetes (T1D) can choose to deliver their essential exogenous insulin by multiple daily insulin injections (MDI) or by continuous subcutaneous insulin infusion  (CSII)  /  pump  therapy.  Unfortunately,  cost  and  logistic  considerations  of  CSII  therapy  still  remain  as  barriers  to  many  patients  <a href="#1" id="ref1">[1</a>,<a href="#2" id="ref2">2]</a>,  with  approximately  10%  of  Australia's &asymp;122,000 people with T1D using insulin pumps. Whilst flexibility and quality of  life  for  people  with  T1D  are  extremely  important,  many  healthcare  and  funding  agencies regard glycaemic control as the outcome of primary importance. </p>

<p class="art-para">A meta-analysis of randomised controlled trials, not clinical practice audits, of CSII vs. MDI reported that relative to MDI use, CSII therapy lowers HbA1c levels by a mean of 0.25% (2.7mmol/mol) in adults with T1D <a href="#3" id="ref3">[3]</a>. Published CSII outcomes in Australia include: results of a user survey by the Australian Institute of Health and Welfare (AIHW) <a href="#1" id="ref1">[1]</a>, a small follow-up study of CSII use in a rural setting in Infu Systems Asia <a href="#4" id="ref4">[4]</a>, an audit of one tertiary referral clinic  <a href="#5" id="ref5">[5]</a>,  and  national  diabetes  conference  abstracts  re  early  pump  experiences  <a href="#6" id="ref6">[6</a>,<a href="#7" id="ref7">7]</a>.  We  now report results of a quality assurance (QA) audit of CSII clinical outcomes from three linked  Victorian  (Australia)  services  with  some  endocrinologists,  diabetes  educators  and  dietician staff in common. These clinics are all bulk-billing (i.e. covered by the national health scheme and at no out-of-pocket cost to patients). The time-frame relates to when CSII use was  not  associated  with  real-time  continuous  glucose  monitoring  (CGM)  use,  which  may  further improve glycaemic control beyond insulin pump alone, but are self-funded.</p>

<p class="art-subhead" id="method">Methods</p>
<p class="art-para"><b>Subjects and CSII Services</b><br/>
Adults  with  T1D  who  commenced  CSII  therapy  during  or  after  2003  at  one  of  three  collaborating services (in an Insulin Pump Clinic in the University of Melbourne, Department of Medicine St. Vincent's Hospital; a clinic run by St. Vincent's (Public) Hospital Department of  Endocrinology  and  Diabetes,  Melbourne;  and  a  clinic  at  the  Werribee  Mercy  Hospital  Diabetes  Service).  Follow-up  was  up  until  mid-2011.  The  University  of  Melbourne  based pump  clinic  provides  a  service  to  other  endocrinologists  to  initiate and stabilise adults on CSII therapy using a shared care model,  in  which  once  stabilised  the  patients  return  to  the  sole  care of their referring endocrinologist or have an annual follow-up  visit  only.  This  service  provides  pre-  and  post-pump  start  support.  Pump  initiations  as  a  day  or  overnight  patient  are  usually performed by the St Vincent's or Werribee public hospital teams  or  by  admission  to  a  nearby  private  hospital.  The  two  public  hospital  clinics  provide  full  CSII  pre-education,  CSII  initiation and follow-up for their own patients, who are usually seen in outpatients about every three months, and more often during  the  pump  stabilisation  phase.  Consultations  are  an  admixture   of   small   group   and   individual   education,   with   carbohydrate counting being assessed, and if necessary taught, pre-CSII initiation. For inclusion in this audit subjects had to have been on CSII therapy for at least three months.</p>
<p class="art-para">Of the 103 T1D adults commencing CSII use adequate data  for  inclusion  were  available  for  77  subjects.  Twenty-six  subjects  could  not  be  included  due  to  either  uncertainty  about  their  insulin  pump  start  date  (n=6),  and/or  a  missing  age of T1D diagnosis (n=17), and/or inability to obtain both baseline and follow-up biochemical measures (n=19). </p>

<p class="art-para"><b>Data collected</b><br />
Age,  diabetes  duration,  weight  and  height  and  blood  pressure  were  recorded  from  medical  records.  Laboratory  tests were performed by NATA accredited public hospital or private pathology laboratories and results obtained by review of  (paper  or  electronic)  medical  records,  or  via  contact  with  the pathology laboratories or treating physician. Data related to hypoglycaemia and hospital admissions were not collected.</p>
<p class="art-para"><b>Statistics</b><br/>Data were recorded in MS Excel (2007) and de-identified data  analysed  to  provide  descriptive  statistics.  Statistical  significance  was  taken  at  p<0.05.  The  nadir  (lowest  HbA1c  since CSII commencement), time taken to achieve it and first time at or since CSII commencement that a patient achieved a HbA1c level below 7% were identified for each patient. The mean annual HbA1c for each patient was calculated from his or her HbA1c values measured each year post-CSII initiation. The  mean  value  for  the  entire  group  or  subgroup  for  each  year was then calculated as the mean of the individual means. Using the same (annual mean of available measures) method we  calculated  the  annual  means  for  blood  lipids,  urinary  albumin/creatinine ratio (ACR). As they were measured more frequently  we  calculated  blood  pressure  and  weight (measured at the clinics) at 4-monthly intervals for up to two years  (as  data  were  sparse  thereafter).  For  comparisons  of  continuous  variables  between  two  groups  unpaired  t-tests  were utilized, and ANOVA with Tukey post-hoc tests. </p>


<p class="art-subhead" id="result">Results</p>

<p class="art-para"><b>Subjects</b><br/>Clinical  and  biochemical  characteristics  are  shown  in  Table 1. Baseline characteristics of the 26 subjects for whom insufficient  data  were  available  to  enable  inclusion  in  the audit did not differ significantly from the 77 subjects described in Table 1. There was a wide range of age and T1D duration at the time of CSII commencement (Table 1 and Figure 1), and there were more female than male subjects commencing CSII. The group was relatively free of vascular complications, with only  two  patients  having  increased  albuminuria,  and  four  subjects having proliferative diabetic retinopathy. No subjects had known cardiovascular disease.</p>

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<p class="art-para">All  but  three  subjects  (who  used  a  twice  daily  insulin  injection regimen) were using a basal bolus MDI regimen pre-CSII  therapy,  usually  basal  flat  profile  insulins  of  Lantus  or  Levemir  and  a  rapid  acting  insulin  such  as  Novorapid  or  Humalog or Apidra. Whilst not recorded for each subject, in our  clinic  the  average  daily  insulin  dose  reduction  for  CSII  therapy  is  approximately  20  -  25%  from  that  used  when  on  MDI.  All  insulin  pumps  were  acquired  via  private  health insurance.  Common  indications  for  CSII  therapy  were  to  improve   glycaemia,   including   reducing   risk   of   severe   hypoglycaemia, for some women to improve glycaemia pre-pregnancy,  and  to  improve  lifestyle  flexibility.  All  subjects  obtained their pump consumables via the Australian National Diabetes  Services  Scheme  (NDSS).  No  subject  was  regularly  using continuous glucose monitoring.</p>

<p class="art-para"><b>HbA1c</b><br/>
There  were  no  statistically  significant  differences  in  CSII  benefit based on HbA1c levels by gender.</p>
<p class="art-para"><b>Greater  HbA1c  reductions  in  CSII  subjects  starting  with  higher HbA1c levels</b><br/>
<p class="art-para">The  mean&plusmn;SD  HbA1c  for  the  entire  group  fell  from  7.8&plusmn;1.2%    (62&plusmn;13mmol/mol)    to    a    nadir    of    6.7&plusmn;0.8%    (50&plusmn;9mmol/mol),  p<0.001,  over  a  mean&plusmn;SD  of  17&plusmn;  20  months.  In  contrast,  in  a  reference  group  of  49  MDI  users  (from the same clinical services) of similar age, sex, BMI and diabetes  duration,  mean&plusmn;SD  HbA1c  over  39.7&plusmn;31.7  months  did  not  change  significantly  from  8.0&plusmn;1.4%  (64&plusmn;15mmol/mol) to 7.8&plusmn;1.2% (62&plusmn;13mmol/mol), p=0.20).</p>
<p class="art-para"> The  subjects  HbA1c  response  with  CSII  therapy  was  evaluated  based  on  their  starting  HbA1c  level.  There  was  a  negative univariate correlation between pre-CSII HbA1c level and the HbA1c drop at the HbA1c nadir (r=-0.76; p<0.0001). There was also a positive univariate correlation between pre-CSII  HbA1c  level  and  the  value  of  the  HbA1c  nadir  (r=0.42,  p<0.0001), both regardless of the time the nadir was reached. As  shown  in  Figure  2,  there  were  significant  relationships  between the tertile of HbA1c at CSII commencement and the size of HbA1c levels reduction.</p>


<div class="art-img">
<img src="<?php echo $imgpath;?>images/mjd-104-f002.gif" class="img-responsive center-block"/></div>

<p class="art-para">As shown in Figure 2, the higher the mean HbA1c at CSII commencement,  the  larger  the  drop  in  HbA1c  (p<0.0001),  with   all   groups   reaching   similar   HbA1c   nadirs,   ranging   between a mean of 6.3% (45mmol/mol) and 7.0% (53mmol/mol).The highest HbA1c group tended to take longer to reach their   HbA1c   nadir,   but   the   time   differences   were   not   statistically significant. </p>
<p class="art-para"><b>Similar HbA1c reductions on CSII across age groups</b><br/>
As shown in Figure 3, all tertiles based on patient age at CSII  initiation  dropped  their  HbA1c  levels  significantly  from  baseline. </p>

<p class="art-para">There  were  no  statistically  significant  differences  in  age  related  starting  HbA1c  level,  HbA1c  reduction,  nadir  HbA1c  or  time  taken  to  achieve  HbA1c  nadir,  though  the  oldest group tended to take longer to reach their HbA1c nadir.</p>

<div class="art-img">
<img src="<?php echo $imgpath;?>images/mjd-104-f003.gif" class="img-responsive center-block"/></div>

<p class="art-para"><b>Inverse relationship between diabetes duration and HbA1c reduction with CSII</b><br/>
Whilst there was not major difference in HbA1c improvement related to gender and age at CSII commencement T1D duration was  related  to  HbA1c  benefit.  Participants  with  shorter  T1D  duration (&#8804; 12 years at CSII commencement) achieved a larger drop  in  HbA1c  (1.8  &plusmn;  1.4%)  vs.  those  with  intermediate  T1D  duration  (12-20  years)  (0.9  &plusmn;  0.8%,  p=0.007)  vs.  those  with  longer (>20 years)T1D duration (1.0 &plusmn; 1.0%, p=0.02).</p>

<p class="art-para"><b>Achievement of HbA1c<7% (53mmol/mol)</b><br/>
Pre-CSII  use,  only  19%  of  subjects  had  a  HbA1c<7%  (53mmol/mol),    whereas    69%    achieved    an    HbA1c<7%    (53mmol/mol)  on  CSII  at  least  once  during  follow-up.  The  percent with HbA1c<7% (53mmol/mol) at years one through four on CSII therapy were 40%, 44%, 40%, 46% (in 73, 57, 48 and 39 subjects) respectively, which was significantly greater than that at baseline. At baseline 16 subjects had HbA1c<7%. The  number  reaching  this  HbA1c  target  for  the  first  time  at  year  1  and  year  2  were  21  and  3  respectively.  The  number  achieving HbA1c<7% for the first time in years 3 and 4 were only one each year. Only two new subjects reached this target in year 5, only one in year 6 and none reached this target for the first time in years 7 and 8.</p>

<p class="art-para"><b>HbA1c levels over time on CSII</b><br/>
Mean HbA1c of the group pre-CSII commencement and for the first two years after CSII initiation and for up to eight years, are shown in Figure 4. </p>
<p class="art-para">Panel A shows the mean group HbA1c data for the first two years at &asymp;4-month intervals post-CSII commencement, with the lowest HbA1c being at 8-12 months. Panel B shows the  data  at  annual  intervals  for  up  to  eight  years  post-CSII  commencement.  The  lowest  annual  HbA1c  (relative  to  MDI  therapy)  for  the  whole  group  was  at  year  1,  a  mean  fall  of  0.6%  (7mmol/mol)  from  pre-CSII  levels.  Mean  HbA1c  levels  tended to increase thereafter, with the difference (albeit with lower subject numbers) at year 5 and afterwards being lower, but  not  statistically  significantly  different,  from  that  prior  to  CSII commencement.</p>
<div class="art-img">
<img src="<?php echo $imgpath;?>images/mjd-104-f004.gif" class="img-responsive center-block"/></div>

<p class="art-para"><b>Durability of HbA1c reduction over time by age group</b><br/>
When   mean   annual   HbA1c   levels   post-CSII   were   compared  based  on  age  group  (shown  in  Figure  5).  There  were no significant differences between age groups.</p>

<div class="art-img">
<img src="<?php echo $imgpath;?>images/mjd-104-f005.gif" class="img-responsive center-block"/></div>

<p class="art-para"><b>Durability of HbA1c reduction over time by starting HbA1c level</b><br/>
The  changes  in  HbA1c  over  time  when  subjects  were  divided  by  baseline  HbA1c  tertile  are  shown  in  Figure  6.  Subjects  with  the  highest  starting  HbA1c  tended  to  have  higher HbA1c levels over time, but these differences did not reach statistical significance</p>

<div class="art-img">
<img src="<?php echo $imgpath;?>images/mjd-104-f006.gif" class="img-responsive center-block"/></div>

<p class="art-para"><b>Other clinical variables</b><br/>
Weight,  blood  pressure,  lipid  levels,  and  urine  ACR  (described  pre-CSII  therapy  in  Table  1)  did  not  change  significantly  over  follow-up.  (Data  not  shown).  Only  two  subjects had increased albuminuria pre-CSII therapy and we are unable to report their change over time as follow-up urine ACR data were not available. </p>

<p class="art-subhead" id="discussion">Discussion</p>
<p class="art-para">In  three  linked  Victoria,  Australia  diabetes  services,  77  subjects, predominantly females, had adequate clinical and biochemical  data  from  pre-  and  post-CSII  initiation  for  (a  paper-based) Quality Assurance audit. There was a wide range of age, T1D duration and HbA1c levels at CSII initiation. Whilst there  were  no  major  differences  in  HbA1c  improvement  related  to  gender  or  age  at  CSII  commencement,  diabetes  duration   and   starting   HbA1c   were   associated   with   the   subsequent change in HbA1c levels. Mean&plusmn;SD HbA1c levels prior  to  CSII  commencement  was  7.8&plusmn;1.2%  (62&plusmn;13mmol/mol),  with  only  19%  of  subjects  on  MDI  achieving  the  recommended  HbA1c  target  of  less  than  7%  (53mmol/mol)  on  MDI.  During  follow-up  (range  0.33-8)  years  on  CSII,  the  HbA1c  nadir  was  6.7&plusmn;0.8%  (50&plusmn;9mmol/mol),  within  the  recommended  target  HbA1c&lt;7%  (53mmol/mol),  achieved  a  mean of 17 months after CSII commencement. Over 40% of subjects  achieve  and  maintain  a  HbA1c&lt;7%  (53mmol/mol)  for up to four years and 69% achieve a HbA1c&lt;7% (53mmol/mol)  at  least  once  during  follow-up.  Most  subjects  first  reached  a  HbA1c&lt;7%  within  the  first  1  or  2  years  of  CSII  commencement.  With  longer  duration  of  CSII  use,  HbA1c  levels tended to rise from the nadir, but remained significantly below  pre-CSII  levels  for  four  years.  Whilst  all  tertiles  of  starting HbA1c reached a nadir HbA1c of 7% (53mmol/mol) or  below,  the  subjects  with  higher  HbA1c  levels  on  MDI  achieved larger HbA1c reductions on CSII therapy than those with better HbA1c levels at CSII commencement. Participants with shorter T1D duration (&#8804; 12 years at the time of CSII commencement)  also  achieved  a  larger  drop  in  HbA1c  than  those with longer diabetes duration. This may relate to lower rates  of  impaired  hypoglycaemia  awareness  in  those  with  shorter T1D duration, though we did not assess this.</p>

<p class="art-para">The majority of patients were using MDI therapy, usually with   long   acting   relatively   peak-less   insulins   (Lantus   or   Levemir)  once  or  twice  a  day,  with  a  rapid  acting  insulin  (Novorapid  or  Humalog  or  Apidra)  pre-meal.  Their  mean  HbA1c  (7.8%  (62mmol/mol))  on  MDI  therapy  was  slightly  better  than  the  national  average  of  8.1%  (65mmol/mol)  for  Australian adults with Type 1 diabetes<a href="#8" id="ref8">[8]</a>. None of our subjects discontinued CSII, in keeping with low national rates of pump cessation (about 1.5%) <a href="#1" id="ref1">[1]</a>.</p>


<p class="art-para">According  to  Australian  reports  (AIHW,  2012)  based  on  NDSS data, almost half of CSII users are below 25 years of age <a href="#1" id="ref1">[1]</a>. As reflected by Table 1 and Figure 1 we had a wide age range  of  subjects  commencing  CSII  therapy,  with  a  mean  diabetes duration at CSII commencement of 17 years, with a wide range (1 - 43 years), with few (4.7%) starting CSII within the first two years of their diabetes diagnosis. We recommend that    clinicians    do    not    limit    their    consideration    or    recommendation of pump therapy to their younger diabetes patients  as  our  data  and  experience  support  that  older  subjects achieve similar glycaemic outcomes. </p>

<p class="art-para">Whilst lower HbA1c levels are associated with lower risk of diabetic vascular complications <a href="#9" id="ref9">[9]</a>, reduced risk of infection <a href="#10" id="ref10">[10]</a>, improved  wound  healing  <a href="#11" id="ref11">[11]</a>  and  better  intellectual  function  and mental well-being <a href="#12" id="ref12">[12]</a>, it should not be the sole reason for CSII  use  or  for  judging  its  benefit.  In  a  survey  of  CSII  users  in  Australia  88%  chose  CSII  to  improve  glucose  control,  and  67%  also desired it for better lifestyle and quality of life <a href="#1" id="ref1">[1]</a>. We did not survey quality of life in our subjects, but their ongoing use of CSII suggests  their  balance  of  benefits  and  advantages  of  CSII  use  were favourable. In other pump studies, including our own, CSII use was associated with improved quality of life <a href="#13" id="ref13">[13</a>-<a href="#18" id="ref18">18]</a>.</p>

<p class="art-para">In  our  clinical  audit  subjects  achieved  a  mean  HbA1c  reduction of 1.1% (12mmol/mol), with more than a doubling of   subjects   achieving   a   HbA1c<7%   (53mmol/mol),   the   generally  recommended  target  in  clinical  practice,  however  we acknowledge that HbA1c targets should be individualised <a href="#19" id="ref19">[19]</a>.  For  example,  for  elderly  people,  patients  with  reduced  hypoglycaemia  awareness,  or  those  living  alone,  a  higher  HbA1c target may be prudent. On average the HbA1c levels and  reductions  observed  are  greater  than  those  reported  in  recent studies <a href="#3" id="ref3">[3</a>,<a href="#20" id="ref20">20]</a>. In Sweden 10 clinics conducted a similar audit on patients with Type 1 diabetes with a mean HbA1c of 8.4% (68mmol/mol) and reported a mean HbA1c reduction of 0.5%   (5mmol/mol)   after   1-year   of   CSII   use   <a href="#20" id="ref20">[20]</a>.   These   differences  likely  reflect  patient  selection  and  differences  in  clinical practice. That all subjects in our study reached similar HbA1c  nadirs  irrespective  of  their  starting  HbA1c  level  may  reflect patient preference so as to limit their hypoglycaemia risk and frequency, which we did not record due to challenges in   the   accuracy   of   data   collection,   effects   of   impaired   hypoglycaemic  awareness,  which  is  not  uncommon  in  T1D,  and the absence of continuous glucose monitoring use.</p>

<p class="art-para">Analysis of our patients' HbA1c results by tertiles of age at CSII  commencement  revealed  similar  HbA1c  benefit  between  age groups, with similar time taken to reach their HbA1c nadir. Similarly, Matejko <i>et al</i>. reported that CSII users aged&#8805;50 years, achieved  similar  HbA1c  benefit  as  those  <50  years  <a href="#21" id="ref21">[21]</a>.Our  outcomes  support  that  adults  with  T1D  of  all  ages  should  be  considered  for  CSII  therapy.  We  did  find  that  shorter  T1D  duration subjects achieved greater HbA1c reductions with CSII use, which may relate to less impaired hypoglycaemia awareness, which is more likely with longer diabetes duration, but we did not  record  hypoglycaemia  awareness.  Our  results  and  that  of  other investigators, such as Matejko, dispel the not uncommon notion that youth perform better than more mature adults with regard to glycaemic benefit with pump use in spite of differences in the hormonal milieu and lifestyle. However, we recognise that self-selection bias is present. Our audit is not able to discern the effects of education and time spent with the diabetes care team that  would  have  been  given  to  those  subjects  starting  CSII  therapy,  nor  assess  whether  the  clinician  time  spent  differed  between age groups or by starting HbA1c level.</p>

<p class="art-para">The weight, blood pressure and lipid levels of our patients did  not  change  significantly  over  time.  The  average  lack  of  weight change with CSII use is in keeping with prior reports. <a href="#22" id="ref22">[22]</a>. Whilst the reduction in insulin dose on CSII vs. MDI therapy may be  associated  with  reduced  appetite,  others  may  gain  weight  due  to  the  greater  flexibility  of  food  intake  and  lower  HbA1c  reducing  (calorie  losing)  glycosuria.  Whilst  better  glycaemic  control  is  usually  associated  with  improved  lipid  levels,  there  were no significant changes. We did not fully record use of and/or changes in diet and lipid or blood pressure medications. Dahl-J&oslash;rgensen <i>>et al</i> reported reductions in albuminuria with CSII use <a href="#23" id="ref23">[23]</a>, likely related to better glycaemia. There was no change in ACR in our subjects, though all but two had normal levels, and we   acknowledge   that   the   urine   ACR   is   a   screening   test.   Epidemiologic studies, such as the Swedish Diabetes Registry v] have  demonstrated  lower  vascular  complication  and  mortality  rates with CSII use than with MDI use, which may relate to better HbA1c  levels,  and  potentially  (not  reported)  also  to  lower  glycaemic variability and lower exogenous insulin doses.</p>

<p class="art-para">Study  limitations  include  incomplete  follow-up  of  all  subjects  commencing  CSII.  Since  undertaking  this  audit  an  electronic data-base has been adopted, so completeness and follow-up of future audits will likely be better and less labour intensive. It is likely that the CSII users received more time and education for the clinicians than those subjects continuing on MDI.  We  did  not  record  clinician  time  to  achieve  the  CSII-related  improved  glucose  control,  but  in  a  subsequent prospective  study  we  demonstrated  that  it  is  significantly  longer  for  nurses,  but  similar  for  doctors  and  dietitians  to  support  CSII  than  MDI  users  <a href="#2" id="ref2">[2]</a>.  As  is  common  in  our  clinic  and  in  that  of  many  of  our  colleagues,  the  majority  of  our  pump users were female; hence the relatively small number of males  evaluated  does  not  enable  robust  comparison  of  potential gender differences in responses. Similarly, very few subjects  had  chronic  diabetes  complications;  hence  we  are  unable to discern if their metabolic responses differed and if this had any effect on their chronic complications. As this is an audit of clinical practice rather than a randomised controlled trial, there may be a (self-) selection bias of pump users being more motivated or more affluent than the general population of  adults  with  Type  1  diabetes.  A  strength  is  that  this  audit represents  'real-world'  clinical  practice  at  different  clinical  sites and with several years of follow-up.</p> 

<p class="art-para">In  conclusion,  we  have  demonstrated  in  our  clinical  practices  that  adult  men  and  women  with  Type  1  diabetes  across  a  wide  range  of  age,  diabetes  duration  and  initial  HbA1c  levels  do  well  with  CSII  use,  with  sustained  HbA1c  reductions and no changes in weight, blood pressure, lipids or urine ACR over time. HbA1c reductions were greater in those starting  CSII  therapy  with  the  highest  HbA1c  level  and  with  shorter   diabetes   duration,   and   were   similar   and   well-maintained in all age groups.</p>

<p class="art-para"><b>Acknowledgements:</b> Authors   thank   all   medical   clinic,   hospital  and  pathology  laboratory  staff  for  assistance  with  data retrieval and their input into patient care.

<p class="art-para"><b>Authors Disclosure Statement:</b> KKC was supported by a travel grant  from  Global  Links,  USA.  AJJ  and  DNO  have  received  honoraria  from  and  conducted  (investigator  and  industry  initiated)  trials  from  Medtronic  and  Sanofi-Aventis,  Animas,  Novo and Eli Lily. AJ is on Advisory Boards for Medtronic and Abbott and DNO is on an Advisory Board for Abbott.RJM has received  honoraria  for  lectures  from  Eli  Lilly,  Novo  Nordisk,  Sanofi-Aventis,  Astra  Zeneca,  Merck  Sharp  &  Dohme,  Bayer  and Norvartis and travel support from Novo Nordisk, Sanofi-Aventis,  Boehringer  Ingelheim  and  Astra  Zeneca.  He  has  received  research  grants  from  Novo  Nordisk  and  Servier,  conducted  industry  initiated  trials  for  Novo  Nordisk,  Bayer,  Johnson & Johnson, Astra Zeneca, Abbive and Versartis and on the Advisory Board for the Boehringer Ingelheim - Eli Lilly Alliance and Sanofi-Aventis.</p>

<p class="art-para"><b>Conflicts of Interest:</b> The authors report no conflicts of interest.</p>



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