INFUSYSTEMS ASIA. INFUSYSTE
INFUSYSTEMS ASIA - INFUSYSTEMS ASIA - INFUSYSTEMS ASIA - INFUSYSTEMS ASIA - INFUSYSTEMS ASIA - INFUSYSTEMS ASIA - INFU
Vol.5 no.2 2010
Continuous subcutaneous Insulin
Infusystems AsIA
Infusion (CsII) use and 2492 Walnut Avenue, Suite 130
Tustin, Ca., 92780, USA
accessibility issues in vision Email: infuasia@yahoo.com
eDItORIAL BOARD
impaired people with diabetes editor in Chief
J-L. Selam (USA)
Lorraine marom, Rn, mn, CDe, nPc Associate editor
D. Selam (USA)
Southern Health, Dandenong Hospital, Australia Board members
Fergus Cameron (Australia)
Arthur Charles (USA)
Neale Cohen (Australia)
Kyung Ah Han (Korea)
T
ype 1 diabetes affects approximately 140,000 Australians, with an Ryuzo Kawamori (Japan)
Bruce King (Australia)
incidence rate of 3.2% per year (1). Approximately 4% of Australians
Kisho Kobayashi (Japan)
with Type 1 diabetes currently use Continuous Subcutaneous Insulin Boniface Lin (Taiwan)
Infusion (CSII) with much higher usage in paediatric clinics (2). David McIntyre (Australia)
Mitsuyoshi Namba (Japan)
David O'Neal (Australia)
Whilst many advances have been made in diabetes management and in laser Carmel Smart (Australia)
therapy and vitreoretinal surgical techniques for sight-threatening retinopa- Hiroshi Uchino (Japan)
thy, vision loss in diabetes is still common (3).
PuBLIsHeR
Publiscripts
This article discusses insulin pump access issues for severely visually 2492 Walnut Avenue, Suite 130
impaired people with Type 1 diabetes and suggests solutions. Tustin, Ca., 92780, USA
Tel: +1 949 910 0991
In addition to the author’s clinical practice experience, a literature review of Fax: +1 949 429 2160
www.publiscripts.com
Ovid MEDLINE and CINAHL databases and the Internet was performed,
and identified two articles regarding CSII suitability for visually impaired
people with diabetes (4, 5). Both involved the AFB TECH Company that ana- sPOnsOReD By
lyzes device interfaces and makes recommendations to industry for making medtronic Diabetes
their product accessible to vision impaired and blind people. The organisation
reviewed interface design of insulin pumps on the American market in 2004
COntents
. Continuous subcutaneous Insulin Infusion (CsII) use and accessibility issues in vision
impaired people with diabetes
.......................................................................................................................................................................................... 9
. Highlights of the 3rd AttD meeting
........................................................................................................................................................................................ 12
Page 10 Vol.5 no.2 2010
2004 2008
Animas IR 1000 Animas IR 2020
Disetronic D-TRONplus Disetronic Accu-chek Spirit
Disetronic H-TRONplus Insulet Omnipod (unavailable in Australia)
Minimed 508 Medtronic Minimed Paradigm 515
Minimed Paradigm 511 SOOIL Diabecare IIS
Minimed Paradigm 512
Smith’s Medical Deltec Cozmo
SOOIL DANA Diabecare II
table 1: Insulin pumps assessed by AFB TECH Company in 2004 and 2008.
and 2008 that includes the pumps, rienced multi-disciplinary team. the accessibility issues reported.
shown in Table 1 (listed alphabeti- Many hospital clinics and Diabetes The author invites collaboration
cally) most of which are currently or Centres recommend pre-pump edu- with interested colleagues in the
recently available in Australia with cation and assessment of suitability region.
the exception of Insulet Omnipod. for pump therapy although suitabil-
ity criteria varies considerably Burton et al (4) recommended
At both time points, all insulin between different settings. A recent changes for improving insulin pump
pumps were determined as not publication by the Victorian CSII design so as to improve accessibili-
being readily accessible to visually Group (6) provides comprehensive ty for diabetic patients with vision
impaired or blind people. This is not guidelines and recommends that loss:
surprising, as insulin pumps were clinical assessment should include a
never designed for this group of review of complication status and 1. Speech output and audio tones
people. Specific problematic design management, particularly those that should identify and indicate exactly
features are summarised in Table 2. will impact on the ability to safely what has occurred and what needs
use an insulin pump such as visual to be done.
Insulin pumps are a state-of-the-art acuity.
tool for diabetes management. 2. Visual displays should incorpo-
People living with visual impair- Research has demonstrated success- rate high contrast, large font and
ment or blindness may also wish to ful outcomes of CSII use in differ- reverse contrast polarity (white text
use insulin pumps when optimal ent patient groups, such as those on a black background).
glycaemia is difficult to achieve with eating disorders, however,
using MDI, but this is currently not research is lacking in the area of 3. Control buttons should be easy to
safe. It is likely to be particularly CSII and vision impairment. identify and use by touch.
challenging and dangerous if Although none of the currently
patients previously established on available insulin pumps are entirely 4. Operating manuals should meet
CSII, become significantly vision programmable non-visually, we large print standards and be avail-
impaired. know that there are people with low able in Braille. Insulin pumps
vision using insulin pumps. The should have the ability to be pro-
Self-management of diabetes is degree of visual impairment in this grammed with a personal computer
considered an essential pre requisite population has not been reported using compatible screen-reader and
for successful initiation and contin- and serious health consequences magnifier software.
uation of CSII therapy with an expe- could result from CSII use due to
Vol.5 no.2 2010 Page 11
Battery Most pumps have a simple battery replacement procedure. The low battery warning is not suit-
replacement able for visually impaired people.
Cannula insertion No pump currently available in Australia has automatic cannula insertion. The Insulet Omnipod
provides automatic cannula insertion by remote control.
Control buttons Raised and textured buttons are tactilely located but are too close together or too flush with
the panel.
Display Apart from the Animas 2020 that has a high level of resolution, contrast and colour, font size is
information too small and display contrast colour is poor.
Documentation Printed materials do not meet large print standards [7] and are not available in Braille or as
recorded voice.
Filling and The low reservoir warning is not accessible to vision impaired people. Complexity varies with
replacing reservoir each pump and no pre-filled insulin reservoirs are available in the 2008 models.
Menu navigation No pump has speech output for menu navigation, programming and alarm/alert messages.
The Insulet Omnipod has a separate remote control panel, but no speech output, for menu
navigation and programming that could reduce some access issues.
Software Diabetes management software for personal computers is not compatible with screen-reader
and magnifier software often used by vision impaired people.
table 2: Adapted from Barton et al Are Current Insulin Pumps Accessible to Blind and Visually Impaired People? (2008).
Insulin pump therapy cannot cur-
rently be recommended for people References 5. uslan, m., Burton, D., Chertow,
with severe visual impairment as B., & Collins R. Accessibility of
pump use in this group could poten- 1. Diabetes Australia Victoria Insulin Pumps for Blind and
tially result in serious, life-threaten- (DAV). Retrieved October 23, 2009 Visually Impaired People. Diabetes
ing consequences. As yet there are from www.diabetesvic.org.au Technology & Therapeutics. 2004;
no guidelines reporting the level of 6(5): 621-634.
vision impairment that is generally 2. Juvenile Diabetes Research 6. Victorian CsII Working Party.
compatible with independent and foundation (JDRf). Retrieved Guidelines for Continuous
safe pump use. October 23, 2009 from subcutaneous Insulin therapy
www.jdrf.org.au/living-with-dia- (CsII) Pump therapy. Retrieved
Current research has identified and betes/what-is-type-1-diabetes November 21, 2009 from
made recommendations for impor- www.diabetesccre.unimelb.edu.au
tant design features that could make 3. shotliff, K., & Duncan, G. in
insulin pumps accessible for vision- shaw, K., & Cummings, m. 7. Kitchel, J.e. Large Print:
impaired people. Diabetes Chronic Complications. Guidelines for Optimal Readability
2005, 1-19. and APHont a font for low vision.
As diabetic retinopathy is a com- Retrieved 21 December 2009 from
mon cause of vision loss, pump 4. Burton, D., uslan, m., www.aph.org/edresearch/lpguide.ht
companies should design insulin Blubaugh, m., & Clements, C. Are m
pumps with features that can be Current Insulin Pumps Accessible
accessed by visually impaired or to Blind and Visually Impaired
blind people. People? Diabetes Technology &
Therapeutics. 2008; 3(3): 613-618.
Page 12 Vol.5 no.2 2010
Highlights of the 3rd AttD meeting
Laure Rocher (1), fabrice Lagarde (2), Pauline schaepelynck (1)
(1) Service de Nutrition-Endocrinologie-Maladies Métaboliques, CHU-
Hôpitaux Sud, Marseille, France
(2) Service de médecine A, Centre Hospitalier, Montargis, France
intensification of treatment. quality of life was improved in all
Counter-regulation and thus studies, and 93% of the patients
The 3rd meeting of ATTD responses to hypoglycemia is lost. preferred the pump. What remains
(Advanced Technologies and An important issue is the evaluation to be clarified is the indications and
Treatments for diabetes) was held in of the relationship between severe the cost/efficacy ratio.
Bale, Switzerland 10-12 February hypoglycemia and mortality rates
2010. (this was one of the a-posteriori R. HenRy (usA) presented the
question of the ACCORD and “new treatment for type 2 dia-
first session: glycemic control VADT studies). Indeed, severe betes”.
in type 2 diabetic patients hypoglycemias increase with: The SGLT2 receptor inhibitors
- age: symptoms threshold is 3.6 allow 90% of glucose be reab-
s. Amiel (uK) gave a lecture on mmol/l and cognitive dysfunction sorbed in the first segment of the
“hypoglycemia in type 2 diabetes: threshold is 2.6 mmol/l in young renal proximal tubules. SGLT1
what is the problem?”. adults. With age, the two thresholds governs the reabsorption of the
Hypoglycemia risk depends on type tend to get closer to each other; remaining 10% in the distal seg-
and duration of diabetes, and treat- - aggravation of insulin deficiency, ment of the proximal tubule.
ment. Hypoglycemia frequency in and glucagon deficiency; SGLT2 inhibition induces an
insulin-treated type 2 diabetes is - other commorbidities and their increase of glycosuria, a reduction
not very well known. Severe hypo- treatments; of blood glucose, an improved
glycemia prevalence in insulin- - intensive insulin therapy, if insulin sensitivity and a reduction
treated type 2 subjects of the inadapted. of the hepatic glucose production.
UKPDS study is certainly underes- The human model for this inhibi-
timated. Some studies (Leese, B. BODe (usA) presented a lec- tion was the familial glycosuria due
Diabetes Care, 2003; Donnelly, ture on “experience with treatment to a recessive mutation of the
Diab. Med., 2005) suggest that of type 2 diabetes using CSII”. In SGLT2 gene. Those rare patients
severe hypoglycemias may be rela- the USA, 37000 type 2 patients are have a 10-130 g/day glycosuria
tively frequent in such patients. In on a pump (Medtronic data, a man- with normoglycemia and no renal
an epidemiologic study (Amiel, ufacturer who owns 78% of the insufficiency. A phase 2 study with
Diabetologia, 2007), the risk of pump market). 4.5 million patients Dapaglifozin (List, Diabetes Care,
hypoglycemia is clearly different are on insulin, including 31% on 2009) showed in 390 patients an
whether patients that have recently multi-injections. Over 80% of improved HbA1c, a reduced FBG
began insulin are type 1 or type 2. patients only inject insulin at home. and an even more important reduc-
In the first two years of insulin ther- In the literature on CSII vs multi- tion of post prandial BG after 12
apy, type 2 diabetic patients have injections, two rather large studies weeks of treatment. The patients in
the same hypoglycemia risk than did not find any difference in A1c the highest dose subgroup also lost
those who have similar HbA1c and levels (Raskin, Diabetes Care 2003; weight (lowest dose 2.5 mg, highest
treated with sulfonylureas. Herman, Diabetes Care 2005), dose 50 mg). But the weight
Hypoglycemia risk increases after 5 three similar studies found that the returned to baseline after the study.
years of diabetes, and the frequency pump was superior to multi-injec- This effect is not insulin dependent.
of hypoglycemia increases with tions in reducing HbA1c. However, Blood pressure dropped too.
Vol.5 no.2 2010 Page 13
Adverse events included some gen- ment of obesity”. This is an attempt elevated) and of cellular apoptosis
ital and urinary infections, a few to involve all players e.g. fat tissue, was pointed out.
polyuria, no nycturia, few renal intestine, pancreas, neuroendocrine
side effects and few hypo- feed back etc. Several combina- m.KOsIBOROD (usA) reminded
glycemias. However, the long term tions of drugs are currently evaluat- us the U shape of mortality where
effects on kidney and bone require ed: GLP1 and YY peptide, hypo and hyperglycemias are asso-
a follow-up. Oxyntomodulin, Amylin and ciated with an increased mortality
- The glucokinase projects: The Metreleptin (targeting hypothala- in ICU, but the lack of evidence of
glucokinases are located in pan- mus and fat tissues), Amylin, a causal relationship multicentric
creas, liver and other neuroen- Metreleptin and YY peptide. randomized studies (Louvain Study
docrine tissues. Human models are and NICE-SUGAR study) have
MODY 2 and neonatal diabetes, A symposium sponsored by Roche evaluated the effect of a conven-
that have an inhibitory mutation of was devoted to “the decisional tools tional vs. intensified glycemic risk
glucokinase. Glucokinase activa- to improve diabetes”: Home blood (Finfer, NEJM 2009; Van den
tors increase kinases affinity and glucose monitoring, log book, Berghe JCEM, 2009). BG levels at
thus increase phosphorylation of memory meters, continuous glu- admission and its variations over
glucose by the beta cells , increase cose monitoring, pumps with bolus the first 24h are predictors of mor-
insulin secretion and reduce hepatic calculators, telemedicine etc. In tality. 78% of diabetic patients and
glucose production. Piragliatine brief, better to be proactive than 26% of non diabetic ICU patients
(Roche) is currently evaluated in a reactive! have a BG level > 140–180 mg/dl.
5 days study. This compound has a The recommended glycemic target
quick action on diabetes parame- second session: “Blood glucose in ICU is 140–180 mg/dl. The val-
ters, but with a fair tolerance monitor in intensive car units” ues 110-140 mg/dl are “accept-
(headaches) and generates hypo- able”. Values above 180 or below
glycemias at high doses. G. VAn Den BeRGHe reminded 110 mg/dl carry too much risk.
us that mortality in ICU was
P. HOme (uK) reviewed “the increased when blood glucose nor- H. De VRIes (netherlands)
long-acting insulin analogs”. He malities were ignored, and ques- insisted that “glycemic variability
reported on the studies comparing tioned the direct effect of glucose plays a role in mortality too”. The
glargine, detemir and NPH. He pro- or insulin. It seems that the combination of hyperglycemia and
vided the web address of the increased mortality was dependent high variability (e.g. > 80 mg/dl/h)
English 2008 guidelines in type 2 on glucose values since insulin is associated with increased mortal-
diabetes (www.nice.org.uk). He therapy without good blood glu- ity. Hypoglycemias prolong ICU
was reassuring on the carcinogenic- cose results has no positive effect, duration. Hypoglycemia risk
ity of glargine. Very long acting whether strict blood glucose con- increase with the reduction of
analogs are currently in phase 1 at trol improves cardiac and renal enteral or parenteral nutrition with
Lilly and 2-3 at Novo Nordisk function. The role of Caspase 3 no adjustment of insulin.
(SIBA-Degludec and SIAC- (that increases when glucose values Hypoglycemia risk also increases
Degludec plus). Duration of action are
is > 24h (BEGIN and BOOST stud-
ies).
L. BJeRRe KnuDsen
NEW WEBSITE
(Denmark) presented the
“Liraglutide properties”. This com-
@
pound has a 97% homology with
www.publiscripts.com where you will find information on how to:
human GLP1, resists to DPP4,
induces rare nauseas (2%), has a . register your email address online to receive future issues of our
cardio-protective effect and reduces publications
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Finally, J. sKyKeR (usA) made
a review on “multihormonal treat-
Page 14 Vol.5 no.2 2010
with renal dysfunction, sepsis, the patient to figure out insulin variations.
inotropic or vasopressive drugs. doses and to make treatment deci-
sions. A. PInKOs from the FDA, con-
session: “mathematical models cluded the sessions, requesting fur-
and algorithms” f. Papadia presented the results of ther studies…
a gastric electrostimulation system
Such models will hopefully allow (Tantalus) to improve HbA1c in session: prandial insulin:
to “close the loop”. R. Hovorka obese diabetic subjects with a BMI options for optimization
presented the Model Predictive 105mg/d or post
quent. The system, the size of half glucose monitoring prandial BG was > 200mg/dl (2.9%
of a pump adhesive, raised the local of patients). The study evaluated
temperature to 38°5C. The battery - V. sKLADneV (Australia) pre- the number of C-sections and of
has a life duration of 7 days for 5 sented the HYPOMON: detection macrosomias, fetal hyperinsulinism
injections/day. of hypoglycemias by recognition of using c-peptide, and neonatal
stress physiological signals (heart hypoglycemias. All these parame-
- H. IyeR (India) presented the rate, sweating…). Studies are in ters seemed to be correlated with
IN105 oral insulin. The goal of this progress. blood glucose values, even when
oral insulin is to control post-pran- not much elevated. Indeed, C-sec-
dial glycemia. IN105 is a stable - y. mAyZeL (Israel) presented tion risk appeared for FBG >
oral insulin with a metabolic activi- the GLUCOTRACK, a combina- 80mg/dl, 1h – 75g glucose BG 134
ty close to insulin, a minimal mito- tion of ultrasound, thermic and mg/dl, 2h BG 110mg/dl. Risks
genic activity this derivative of electromagnetic technologies. Each increase linearly for rising blood
LYS B-29 containing alkyl PEG technology provides a blood glu- glucose values. 76% of the patients
has essentially a liver action. The cose reading but is limited by inter- that were not diabetic during preg-
first results look promising. ferences, different for each technol- nancy had FBG
communication on utilization of device is clipped on a finger. 85mg/dl, 1h -75g > 150mg/dl and
halozymes to improve insulin Calibration is made before and 50 2h 75g > 124 mg/dl. The authors
absorption. This technique uses minutes after breakfast. proposed as diagnostic criterias:
hyaluronidase, the first genetically FBG: 92mg/dl, 1h -75 g 180 mg/dl,
produced enzyme for improving session: management of 2h- 75g: 153 mg/dl, with one value
insulin absorption. The enzyme diabetes during pregnancy defining diabetes. The HAPO study
first dissociates insulin hexamers, was followed by the NFMU study
after diffusing through the SC tis- - m. HOD (Israel) revisited the which confirmed the link between
sue, then operates by convection. diagnostic and classification crite- glycemia and the risks of dystocia,
Lispro is 50% more rapid when ria and noted that it took 46 years C-section and pre-eclampsia. The
associated with hyaluronidase in before a consensus could be authors wanted the glycemic
healthy volunteers during an eug- obtained. He reminded us that the thresholds to be correlated with an
lycemic clamp. The phase 2 studies O’Sullivan criteria was not corre- increased risk of complications
are in progress on type 1 diabetic lated with pregnancy outcomes but rather than with the values the most
. Evaluating investigational medications from
pharmaceutical companies on diabetic subjects under FDA-approved study protocols.
. For Phase 1-4 Clinical Trials
. Tel: +1 714 734 7944
. Website: www.uciinc.net
Page 16 Vol.5 no.2 2010
frequently observed in a popula- that maternal risk for a given post- The two other publications
tion. As an example, 11% of preg- prandial glycemic level. When (Crowther, New England JM 2005,
nant women have a FBG>90 mg/dl. maternal glycemia is increased by a and London, New England JM
This threshold identifies 17% of factor 2, fetal risk is increased by 2009) unfortunately did not define
macrosomias. 38% of the popula- 17. Finally, it seems that glycemic glycemias in the control group.
tion has fasting blood glucose val- holters are not discriminatory for Therefore, the question is which
ues between 80 and 89 mg/dl and low glycemic values. glycemic objectives and which
have only 10% of macrosomias. parameter to measure (HbA1c?
49% of the population has FBG 126 mg/dl, or during pregnancy are gestational only mimic glycemic normal val-
random BG > 200 mg/dl or a diabetes (90%) type 2 diabetes ues. Continuous glucose monitor-
HbA1c > 6.5%. (6%) type 1 diabettes (3%) other ing has limited usage, is costly and
diabetes(1%). Only 32% of diabet- does not correlate with obstetrical
- L. JOVAnOVIC (usA) defend- ic women have their pregnancy risk. There is no study on glycemic
ed the “utility of continuous glu- programmed. 5600 publications variation during pregnancy except
cose monitoring during pregnan- including 434 clinical cases were the ARTAL study (AJOG 1993) on
cy”. Continuous glucose monitor- devoted to gestational diabetes in 154 patients hospitalized during the
ing has shown to patients and their 2009, but only a few studies have last month of pregnancy. In this
doctors that pregnant women were been devoted to treatment. study, glycemic variability was
not as compliant as expected and Langer (American Journal associated with an increased risk of
that many hyperglycemias were Obstetrics Gynecology, 2005) in a complications. It is difficult to pro-
ignored. There is a lag time retrospective study found a signifi- vide a uniform definition of a so-
between capillary post-prandial cant difference between treated and called good glycemic control for
peaks (60 min) and post-prandial untreated patients, with 17 vs 7% recommendations since it varies
interstitial peaks (72 min). Glucose macrosomias, 23% vs 7% perinatal with the complication that needs to
monitoring is very useful when complications, and 16% vs 7% of be prevented.
steroids are necessary to accelerate dystocias in the untreated and treat-
fetal maturity and in twin pregnan- ed groups respectively. There was t. BAtteLInO concluded the
cies where the fetal weight criteria no significant differences in terms meeting. The next meeting will be
is not available. She reminded that of neonatal hypoglycemia, hyper- held in London in 2011.
fetal risk increases more rapidly bilirubinemia and chord C-peptide.
Medtronic Diabetes is the world leader
in insulin pump therapy and continuous
glucose monitoring.
We are rmly committed to helping people
living with diabetes live healthier lives
by providing superior technology and
responsive customer support.
To learn more about Medtronic Diabetes,
please visit one of our websites:
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