ENGR0011 Sanchez 4:00
R05
THE DIABETIC DILEMMA
Jake Muldowney (jjm147@pitt.edu)
ETHICAL DILEMMA
I am a bioengineer assisting with a long-term study
testing the functionality of a new closed-loop continuous
glucose monitor and insulin pump system. My job is to
interview patients to determine if they would make good
candidates for the study, and recruit them if I deem this to be
the case. The patients and their parents or guardians must sign
an informed consent form, confirming that they are aware of
the medical risks associated with the study. Things are going
very well and we anticipate a breakthrough, however, very
few new candidates seem to be prepared to take part in the
study. My superiors are encouraging me to recommend
participation to newly-diagnosed diabetics, who are just
getting used to managing the disease and are rarely considered
ready for pumps, let alone integrated pump and continuous
glucose monitor systems.
The study could have a positive impact on the quality of
life of the candidates, and will likely promote advances in my
research. However, there is a chance that patients could
encounter psychological distress. Studies have shown that,
post-diagnosis, diabetics often go through periods of denial
and low self-esteem, and diabetics switching to the insulin
pump experience feelings of being overwhelmed by
additional changes. I must therefore weigh the value of my
own research and the chance of helping a large group of
diabetics against the chance of causing undue psychological
distress to a group of test candidates.
POSSIBLE BENEFITS
New participants in the study can only accelerate the pace
of the critical research in which I am involved. Successful,
replicable and mass-producible implementation of a closedloop system would mean a huge improvement of quality of
life of all diabetics. Closed loop systems are on track to
provide immediate relief to the psychological pressures of the
disease, taking much of the responsibility of a diabetic and
automating it. In addition, the algorithms that could be
developed from this research could be used in implantable
devices or artificial pancreas solutions, which could serve as
a sort of “cure”, completely alleviating all symptoms of
diabetes.
The quality of life of the original test candidates is also a
concern. In the long term, learning how to use the most
modernized systems early on in treatment would give newly
diagnosed diabetics a much higher degree of control over their
situations. Furthermore, they would never experience any of
the more traditional phases of treatment, which are generally
less effective than the new closed loop systems.
University of Pittsburgh, Swanson School of Engineering
2014-10-28
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I have noticed that both in my life and in those I work
with that diabetes treatment typically follows a progression,
beginning with closely scheduled insulin shots and careful
carbohydrate counting, maintaining a specific diet and
following a strict medication regimen. This regimen involves
both a short and long acting form of insulin NovoLog and
NPH, respectively. This plan results in a total of
approximately 6 shots a day. From there, diabetics often move
to a Lantus or Levemir regimen. Lantus and Levemir are two
very similar forms of very long acting insulin, typically
requiring one shot per day of each. In addition to this, dietary
restrictions are loosened somewhat, with the contingency that
carb counting continues and a shot of short acting insulin is
taken with each consumption of food to keep blood glucose
under control. The next level, just before the application of
CGMs, is the use of an insulin pump. These devices typically
require an infusion set to be changed every 3-7 days in a short,
at-home procedure. However, that is the only injection
required, as the pump leaves a cannula inside the body and
delivers a steady drip of insulin, with the ability to deliver
larger amounts of insulin, known as boluses, to deal with
meals and high blood glucose caused by outside factors.
Compared to the early steps in the traditional
progression, new systems have been shown to reduce average
blood sugars. These averages are determined by taking a 3month mean blood sugar, called the A1c index. Patients on
pumps and CGMs typically carry an A1c around 1 full point
below their injection-treated counterparts. This reduction of
average blood sugar helps avoid many of the long-term risks
of diabetes, including an extremely increased likelihood of
both kidney failure and glaucoma. Therefore, new patients
starting on these systems stand to gain both in the short and
long term.
After weighing all these potential gains, I look to the
other side of the issue, and the risks posed to these test
candidates.
ASSOCIATED RISKS
Like many chronic diseases, Type 1 Diabetes has both an
immediately apparent physical element and an aspect of
psychological stress. New diabetics often struggle with
feelings of denial and anger in the early stages of the disease
[1]. Furthermore, over the course of 10 years, diabetics
showed an increased trend towards low self-esteem,
diminished self-worth, and feelings of reduced sociability
compared to patients with acute disorders and diseases. In
addition, studies have shown that young and newly-diagnosed
diabetics typically have a 10% increased chance for
developing depression.
Jake Muldowney
Diabetes also has severe ramifications on the families of
the newly diagnosed. Studies have shown that between 22%
and 28% of parents and guardians experience symptoms of
post-traumatic stress disorder within 6 weeks of the diagnosis
of their child. Other studies show that the presence of a
support structure, especially from parents, is instrumental in
maintaining psychological health in newly diagnosed
diabetics. Diabetics lacking a support system at home
experience increased anxiety, more reduced self-esteem, and
a higher likelihood of both depression and suicide ideation
[1].
While the initial stresses of developing diabetes are
unavoidable, there is another set of issues surrounding pump
usage, especially in new diabetics. The reason for concern
when considering jumping straight to insulin pump use,
especially in tandem with a CGM, is the additional
psychological stress and day-to-day changes caused by these
devices. While using the pump means less shots, it also adds
the element of always being attached, physically, to a device.
While insulin injections can be performed discreetly within
the confines of one’s home, or in a restroom, a pump and the
associated infusion site on the body can never be ignored.
When a priority of many diabetics is to “Not be treated
differently than others” [2], a constantly present reminder of
their difference is never welcome.
An additional layer of stress is added by the presence of
a continuous glucose monitor in the closed-loop system.
CGMs consist of another attached, “always on” device,
another subcutaneous, sometimes painful needle, and a
nonstop flow of information. While the closed loop would
handle a large amount of this information, the newness of the
technology involved and the restrictions of the study would
require a test candidate to use a CGM with predictive and
reactive alarms. Predictive alarms look at trends and changes
in BG over the past short period of time to predict
hypoglycemic and hyperglycemic excursions, or low and high
blood sugars, respectively. Reactive alarms are the second
line of notification, alerting the user if their blood glucose has
gone beyond normal levels. The constant stream of
information and presence of several attached devices, as well
as the stress associated with simply being diagnosed with the
disease, could very well overwhelm a child or young adult
that could be considered for candidacy [3].
Furthermore, both the disease itself, the insulin pump,
and CGM systems all require training periods of between one
week and several months. Overlapping these periods could
cause stress for both the new diabetic and their caretaker, as
they struggle to absorb information from several sources and
acquire an understanding usually developed over several
years in a matter of months.
The huge amount of emotional and mental stresses
associated with diabetes, in addition to the stresses of
beginning insulin pump use and those associated with
continuous glucose monitoring, could very well combine and
cause severe emotional distress or even psychological damage
in a child. This is a risk that must be weighed heavily against
any possible advantages associated with new treatment
options.
ETHICAL ANALYSIS
According to Canon 1, subsection A of the
Bioengineering Society of America Code of Ethics, [4] it is of
paramount importance to consider the long-term
ramifications of my research as it pertains to public health.
Canon 2, subsection B of the same doctrine states that I must
also therefore consider the consequences of my work and how
it will affect availability of healthcare in the future. My
research seeks to notably improve the quality of diabetes care,
which would have a major positive effect in the long term.
Furthermore, the alleviation of issues associated with the
early stages of diabetes treatment would help ward against
future complications. Canon 2, subsection 1 of this doctrine
calls attention to my responsibility to those involved in the
study. It asks me to weigh the chance of improved physical
health against the possibility of psychological distress and
other emotional issues that could arise.
On the other hand, that same responsibility to those
involved in the study mandates that I act in their best interests.
When the psychological health of a young person is at risk,
one must immediately take pause and determine if continuing
the course of action would benefit or harm the child in
question. The fact that the possible ramifications could be so
severe prevents me from simply continuing with the study as
my employer recommends, and I instead turn to several case
studies.
CASE STUDY 1: THE BRIDGE COLLAPSE
AND DUTY TO WARN
The first case study I find seems only tangentially related
to the biomedical engineering profession. It deals with a
suspension bridge in California, which collapsed with 40
people on it, killing and injuring several. It looks at the extent
to which California Attorney General’s Opinion Number 85208 can be applied to a situation. This opinion states that a
registered engineer hired to investigate a situation has a duty
to warn the building’s occupants if they face serious risk due
to an observed hazard. While newly diagnosed diabetics are
not buildings, the doctrine can logically be extended to cover
my research candidates. It seems that I have a duty to warn
these patients of possible compounding of psychological
threats. However, further reading shows that when the issue
was taken to court, “The court ruled against the plaintiffs,
stating, ‘Mere knowledge of danger to the individual does not
create an affirmative duty to protect.’” [5] Therefore, my
course of action is once more decided largely by my own
opinion, with this case study offering no concrete details
favoring either side of my own dilemma, but rather new
elements supporting each possibility.
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Jake Muldowney
control if the ethical dilemma surrounds a major failure.
Having worked my way through these steps and determined
my course of action, I then plan my final actions to resolve
the diabetic dilemma.
CASE STUDY 2: PATIENT RECRUITMENT
This study, from the Stanford Biodesign Ethics portal,
deals with issues of a subordinate bioengineer having doubts
about the candidacy of several individuals his superiors are
recommending for research. The parallels between this and
my own situation are obvious, so I begin analyzing the case.
The fictional study in question is using possibly unsound data
to determine candidacy of patients for a cardiovascular study.
After reading a synopsis, I am asked a few questions. The
most hard-hitting of these are, “What should you do in your
interaction with each patient as you are left to explain the
protocol and have the informed consent forms signed?” and
“What should you say to the patients who ask you whether
you think they should join this double-blind placebocontrolled study?”[6].
I realize that to successfully follow Canon 3 of the NSPE
code of ethics, namely “Engineers shall avoid the use of
statements containing a material misrepresentation of fact or
omitting a material fact” [7], I must fully inform the test
subjects of both the possible risks and associated benefits of
joining the study before I can offer an informed consent form.
I therefore resolve to offer a full explanation, similar to the
ones present earlier in this report, to all candidates after
informing them of the nature of the study and before offering
them an informed consent form and asking for their
participation. This allows me to continue my research and
maintain compliance with engineering ethics. Before I move
on, however, one more case study catches my eye. Not
because it applies particularly well, or offers insight into my
own scenario, but because it offers a very useful method for
analyzing any ethical dilemma.
CONCLUSION
After referring to several psychological papers, two
codes of ethics, several ethical case studies, a “Coping with
Diabetes” book and my own personal experiences as a
diabetic, I have reached a decision. I will continue to offer
newly diagnosed diabetics the opportunity to participate in
this program. However, to maintain ethical propriety, I will
also inform them of the risks involved. They will therefore be
fully briefed on all aspects of the situation before they come
to a decision to sign an informed consent form or decline to
participate. This solution will uphold all aspects of two
canons of ethics for engineers, and furthermore, assuages any
feelings of doubt or guilt I would have about the situation. It
offers a win-win resolution, where the real winners are the
researchers and diabetics of the future.
REFERENCES
[1] National Collaborating Centre for Women’s and
Children’s Health (2004) “Type 1 Diabetes: Diagnosis and
Management of Type 1 Diabetes in Children and Young
People”
PubMed
Health
(online
article)
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0015995/
[2] H. Chase et. al. “Psychological Aspects of Insulin Pump
Use”
(book
chapter)
http://www.ucdenver.edu/academics/colleges/medicalschool
/centers/BarbaraDavis/Documents/bookinsulin_pump/pump14.pdf
CASE STUDY 3: ETHICS GUIDE FOR
UNDERGRADUATE RESEARCH
[3] L. Messer “Who Should Use Continuous Glucose
Monitoring”
(book
chapter)
http://www.ucdenver.edu/academics/colleges/medicalschool
/centers/BarbaraDavis/Documents/bookinsulin_pump/pump15.pdf
The webGURU Guide for Undergraduate Research
offers a 6 step process for analyzing and resolving ethical
issues [8]. Step 1 is determining the action or inaction that is
the cause for concern. Here the issue is as stated in the
opening section of the paper. Step 2 is determining who is
affected by the situation. In this situation, those affected are
the young test candidates and their families. Step 3 is
determining how they would be affected by the scenario.
These potential effects have also been outlined earlier in the
paper, and include the positive physical aspects and potential
negative mental effects. The next step is looking at legal
ramifications of the issue. The entire situation is legally
aboveboard. Step 5 asks me to look at actions that may be
taken, and their potential consequences. Analyzing my
possible courses of action yields one option that appears better
than the rest: Inform the potential candidates of all the
associated risks, and then leave it to the candidates and their
parents to determine what they would like to do. The final step
does not heavily apply to the situation, and focuses on damage
[4] Biomedical Engineering Society (2004) “BMES Code of
Ethics”
(web
article)
http://ethics.iit.edu/ecodes/?q=node/3243
[5] J. Kardon (2010) “Bridge Collapse and the Duty to
Warn” Online Ethics Center (web article)
http://www.onlineethics.org/Resources/Cases/24355.aspx
[6] Stanford University “Case 13- Patient Recruitment”
Stanford Biodesign (web article)
http://biodesign.stanford.edu/bdn/ethicscases/13patientrecrui
tment.jsp
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Jake Muldowney
[7] National Society of Professional Engineers (2007)
“NSPE Code of Ethics for Engineers” (web article)
http://www.nspe.org/resources/ethics/code-ethics
[8] webGURU (2010) “Sometimes Silence is Golden” (web
article) http://www.webguru.neu.edu/professionalism/casestudies/sometimes-silence-golden
ADDITIONAL SOURCES
Personal experience: Nine years of life with diabetes and
constant consumption of diabetes research and treatment
related media gives me a large amount of foreknowledge of
the topic at hand.
Children’s Hospital Of Philaelphia (2005) “Manual for New
Diabetics” (print book)
ACKNOWLEDGEMENTS
I would like to thank my floormates for reading through my
work, my family for constant emotional support, and my
friends for helping me stay motivated. I would also like to
thank Dr. Budny and Dr. Sanchez for showing me what it
means to be an engineering student. Finally, I would like to
thank Dan McMillan, my writing instructor, for being the
unseen, shadowy hand that guides the development of my
writing.
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