© 2012 Expert Reviews Ltd
James M Hempe2,
Vivian Fonseca3 and
1School of Public Health and Tropical
Medicine, Tulane University,
1440 Canal Street, New Orleans,
LA 70112, USA
2Research Institute for Children,
Children’s Hospital New Orleans,
200 Henry Clay Avenue, New Orleans,
LA 70118, USA
3School of Medicine, Tulane University,
1430 Tulane Avenue, New Orleans,
LA 70112, USA
*Author for correspondence:
Tel.: +1 504 988 6548
Fax: +1 504 988 3783
Hypoglycemia is an acute complication of diabetes that increases morbidity, mortality and
economic costs of diabetes. It presents major clinical problems for the management of Type 2
diabetes as this disease represents the great majority of all diabetes cases. Hypoglycemia makes
it difficult for some individuals to achieve good glycemic control, reduces quality of life and
increases the burden of diabetes to healthcare systems. Understanding hypoglycemia risk factors
can help patients with Type 2 diabetes to correct and avoid hypoglycemia. Recently, an increased
risk of hypoglycemia with intensive glycemic control has been identified as an important problem
in optimally controlling blood glucose levels in patients with Type 2 diabetes.
Keywords: economic burden • glucose control • hypoglycemia • insulin • Type 2 diabetes mellitus
Economic burden of
hypoglycemia in patients with
Type 2 diabetes
Expert Rev. Pharmacoeconomics Outcomes Res. 12(1), 47–51 (2012)
period of 5 years in the ADVANCE study .
Although severe hypoglycemia is uncommon
in Type 2 compared with Type 1 diabetes, epi-
sodic frequencies are similar in insulin-treated
patients with Type 2 diabetes for >5 years and
Type 1 patients for <5 years . The annual
prevalence of severe hypoglycemia reached 15%
among insulin-treated Type 2 diabetes . This
suggests that hypoglycemia becomes a more fre-
quent clinical problem for patients with Type 2
diabetes as they approach the insulin-deficient
end of the diabetes spectrum .
Furthermore, milder hypoglycemic events
associated with tight glycemic control can occur
so frequently over time that they cause unpleas-
ant neuroglycopenic and autonomic symptoms
, increase the risk of accidents or injuries [16,17],
create fear and anxiety [15,17,18], and ultimately
result in poor glycemic control. Recurrent hypo-
glycemia episodes may produce hypoglycemia
unawareness and subsequently severe hypo-
glycemia, permanent neurologic injury or even
death. Taken together, these observations indi-
cate that recurrent hypoglycemia can lead to a
rebound state of hyperglycemia, which increases
the risk of diabetes complications, hastens pro-
gression to adverse clinical outcomes, and ulti-
mately leads to increased healthcare costs and
poorer long-term quality of life.
Type 2 diabetes accounts for approximately
90–95% of all cases of diabetes in the USA.
Diabetes and its acute and chronic complications
are significant causes of morbidity and mortality
in the USA. It is now well established that inten-
sive glycemic control reduces the risk of diabetic
microvascular complications in both Type 1 and
2 diabetes [1–4]. It may also reduce the risk of
macrovascular events [2,5–7]. However, the use
of intensive glycemic management regimens
to achieve glycated hemoglobin (A1C) <6.5%
remains controversial compared with somewhat
higher A1C levels (e.g., A1C <7.5%), due to lack
of proven benefit and potential risks, including
severe hypoglycemia [2,5–8].
Hypoglycemia is a common side effect of anti-
hyperglycemic therapy in diabetes. It is also a
primary obstacle to good glycemic control, as
noted in recent large randomized clinical tri-
als evaluating the benefits of intensive glyce-
mic control in Type 2 diabetes (UKPDS ,
ACCORD , VADT  and ADVANCE [3,10]).
The episodes of hypoglycemia are much less fre-
quent in patients with Type 2 than Type 1 dia-
betes. Only 2.5% per year reported substantive
hypoglycemia among patients on monotherapy
for 6 years from diagnosis in UKPDS . In
the ACCORD study, the annual incidence of
hypoglycemia was 3.14 and 1.03% in the inten-
sive treatment and standard glycemia groups,
respectively . A total of 44.7% reported
minor hypoglycemia and 2.1% reported severe
hypoglycemia events during a median follow-up
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Expert Rev. Pharmacoeconomics Outcomes Res. 12(1), (2012)
Intensive management of glycemic control while avoiding hypo-
glycemia represents a significant challenge to clinicians over a
patient’s lifetime of Type 2 diabetes. It is therefore important that
clinicians evaluate the risk of hypoglycemia in diabetes patients
before initiating aggressive glycemic control and take steps to
correct factors that exaggerate risk. The aim of this review is to
assess the economic burden of hypoglycemia based on published
studies on Type 2 diabetes, many of which only included patients
using insulin for their diabetes.
The economic burden of hypoglycemia in Type 2
Diabetes affected 25.8 million Americans in 2010 . The
estimated total cost of diabetes was US$174 billion in 2007 ,
including US$116 billion in medical expenditures and US$58 bil-
lion in reduced national productivity. The economic burden of
diabetes will continue to increase as the epidemic of diabetes rises.
Hypoglycemia is an acute complication of diabetes. Although
the treatment for hypoglycemia is not as costly as those treat-
ments for other complications such as cardiovascular disease, the
cost of hypoglycemia is considerable because it can happen so
frequently and sometimes seriously to both affect daily life and
cause morbidity and even death.
Calculating the cost of hypoglycemia is a complex issue that
involves direct and indirect costs associated with each episode
and depends on how frequently episodes happen. Direct medical
cost varies depending on the severity of the hypoglycemic episode
that ranges from negligible (e.g., resolved by snacking) to severe
(e.g., requiring emergency care or hospitalization). Cost estimates
differ from country to country and between different healthcare
systems, based on the quality of service and the extent of treat-
ment. The estimate of the cost of hypoglycemia in Type 2 diabetes
also depends on the frequency of episodes. It is difficult to assess
the absolute rate because of the lack of consensus of classification
of hypoglycemia and under-reported self-treated episodes. Few
studies have assessed the cost of hypoglycemia in Type 2 diabetes.
Since there is no published report regarding the costs of mild-
to-moderate hypoglycemia, the costs were only calculated for
episodes of hypoglycemia severe enough to have required use of
medical resources. O’Brien et al. reported the average direct medi-
cal cost as US$188 (in 1996 US$) per episode of hypo glycemia
that had used medical resources in the USA . Mean cost per
episode among patients with Type 2 diabetes using insulin was
calculated using claims data, with an estimate of US$1049 per
episode between 2001 and US$4004 in a southeastern US man-
aged care plan , and US$1186 (range: US$181–4924) per epi-
sode between 1992 and 1998 in a large US mid-western health
A cost-of-illness ana lysis based on an incidence methodology
was used to estimate the total cost of hypoglycemia (defined as
episodes requiring assistance from another person, medical per-
sonnel or not) in Type 2 diabetes and extrapolate to a national level
in Sweden [23,24]. Three levels of episodes were assessed based on
health resources used, which were mild (assistance from another
person but no medical attention), moderate (medical attention but
no hospitalization) and severe (leading to hospitalization). Direct
and indirect costs per event of mild, moderate and severe hypo-
glycemia were estimated to be €26 and €37, €335 and €45, and
€2807 and €1111, respectively. Investigators further assumed that
the rate of hypoglycemia frequency was 0.09 events per patient-
year, and that there were 300,000 patients with Type 2 diabetes
in Sweden. In this scenario, it was extrapolated that 26,942 hypo-
glycemic events would occur annually in Swedish patients with
Type 2 diabetes. The total cost of hypoglycemia was estimated
to be €4,250,000 (€14 per patient with Type 2 diabetes) per year
in Sweden, of which moderate episodes contributed the largest
proportion. Similarly, in a French study, the medical cost of a
single hospitalized hypoglycemia event was FF14,000 (US$2100)
in 1992, with a mean length of stay of 6.6 days .
Rhoads et al. analyzed the claims of 2664 employees of five
large US companies with Type 2 diabetes patients who were on
insulin from 1999 to 2001 . The annualized medical expendi-
tures directly related with hypoglycemia diagnosis were US$3241.
In Germany, the total annual medical cost of severe hypo glycemia
amounted to US$44,338 per 100,000 inhabitants for Type 2 dia-
betes patients from a comprehensive population-based ana lysis
between 1997 and 2000 .
Ambulance and hospital expenses represent the great majority
of the costs in medical care utilization and expenditures related
to hypoglycemia [21,28]. Several studies estimated the frequency of
hypoglycemic events using records from ambulance and hospital
accident and emergency department records. For example, the
National Hospital Ambulatory Medical Care Survey reported
that hypoglycemia accounted for approximately 5.0 million emer-
gency visits nationwide between 1993 and 2005, an average of
380,000 visits/year in the USA, of which 25% resulted in hospital
admissions . The visit rate per 1000 diabetic subjects was 34
(95% CI: 30–37). However, actual expenditures associated with
these events were not estimated. A population-based study on the
use of health service resources analyzed the frequency of severe
hypoglycemia requiring emergency treatment and estimated
direct total relevant costs in the UK . The study documented
all episodes of hypoglycemia between June 1997 and May 1998
that required emergency treatment from primary care, ambu-
lance, hospital accident and emergency departments or inpatient
care in Tayside, Scotland: a community of 367,051 people, includ-
ing 8655 diabetes patients. They identified 244 cases of severe
hypoglycemia, of which 57% were in patients with Type 2 dia-
betes. The estimated direct cost of treating severe hypoglycemia
due to Type 2 diabetes was GBP£7.4 million per year in the UK
based on diabetes prevalence figures in the Tayside study [29,30].
A study of primary care healthcare resource use reported that
the mean number of visits to a nurse or physician in the UK for
mild/moderate and severe hypoglycemia was 11.5 and 13.2 vis-
its, respectively, per patient with Type 2 diabetes over a 6-week
period. The investigators calculated that the approximate cost of
mild/moderate hypoglycemia ranged from GBP£92 if all consul-
tations were with a practice nurse to GBP£287.5 if all consulta-
tions were with a general practitioner . Corresponding figures
were GBP£105.6 and GBP£330 for severe hypoglycemia .
Liu, Zhao, Hempe, Fonseca & Shi
One major measure of indirect costs is the reduced working
capacity. The episode evaluated was the most severe hypoglycemic
episode in the previous 3 months and patients with both Type 1
and 2 diabetes were included in the study. One episode of hypo-
glycemia resulted in the loss of 3.1 productive days on average
per patient with Type 2 diabetes in the UK [30,31]. Respondents
had to have had at least one nonsevere hypoglycemic episode
during the previous month to be included in the study. Hours of
lost work only included episodes that resulted in missing work
time. Respondents of an internet multicountry survey reported
8.3–15.9 h of lost work time per nonsevere hypoglycemia episode
per month if any, depending on the residents and the time/place
of the episode . In detail, lost work time due to episodes dur-
ing working hours was 10.2 h in the USA, 11.4 h in the UK,
8.3 h in Germany and 8.9 h in France; lost work time due to
episodes outside of working hours was 11.1, 15.1, 9.2 and 12.4 h,
respectively; and lost work time due to nocturnal episodes was
14.3, 14.2, 12.5 and 15.9 h, respectively. Corresponding lost pro-
ductivity was estimated to range from US$15.26 to US$93.47
among employees using insulin for whom medical records were
available in the study. In the study by Rhoads et al., employees
with hypoglycemia used on average 8.7 more short-term disability
days (STD) per year than persons without hypoglycemia .
Most STD days started in the week after a hypoglycemia diagno-
sis, with the incidence of STD increased to 4.69%, which indi-
cated a relative risk of fivefold after excluding hospital discharge
diagnoses of hypoglycemia.
Notably, the indirect cost may be much greater due to the long-
term negative impact of recurring hypoglycemia on glycemic
control, adverse clinical outcomes and reduced quality of life.
Davis et al. also reported the mean utility score of 0.77 (standard
deviation [SD]: 0.17) in patients (Type 2 diabetes) with noctur-
nal events, 0.65 (SD: 0.33) with mild/moderate events and 0.53
(SD: 0.38) with severe events, according to the self-completed
survey in the UK . Episodes of severe hypoglycemia may cause
anxiety, depression and fear of hypoglycemia, which may stymie
efforts to maintain near-normal long-term glycemic levels. Severe
hypoglycemia may be associated with the onset of diabetes com-
plications. A post hoc study using ADVANCE data examined
the association between severe hypoglycemia and the risks of
macro-/micro-vascular events and death . A strong associa-
tion was found, with adjusted hazard ratios of 2.88 (95% CI:
2.01–4.12) for macro vascular events, 1.81 (95% CI: 1.19–2.74)
for microvascular events and 2.69 (95% CI: 1.97–3.67) for all-
cause death. Higher risks were also found for nonvascular events
(e.g., respiratory, digestive and skin conditions) associated with
hypoglycemia. Whether or not hypoglycemia is the cause of these
clinical events, these findings indicate increased healthcare utili-
zation and costs and poorer quality of life among these patients
(i.e., those with hypoglycemia) with Type 2 diabetes.
Hypoglycemia has a substantial adverse impact on mortality,
morbidity and quality of life in ways that markedly increase the
economic burden of healthcare on human societies. The financial
costs of hypoglycemia include direct medical costs but also indi-
rect costs associated with inability to work, which adds to the total
adverse economic impact of hypoglycemia on diabetes outcomes.
At present, hypoglycemia remains a major limiting factor to the
use of optimal glycemic control for diabetes management, partic-
ularly for patients with Type 1 diabetes and those with advanced
Type 2 diabetes as they progress toward the insulin-deficient stage
of the disease. Since a primary cause of hypo glycemia is due to
either insulin therapy or to insulin secretagogues such as long-
acting sulfonylureas, efforts to avoid exposure to hypoglycemia
remain a top priority.
A large body of information indicates that optimizing therapies
to mimic real-time plasma glucose fluctuations can minimize
the risk of hypoglycemia and still provide good glycemic control
. A current statement by the American Association of Clinical
Endocrinologists/American College of Endocrinology recom-
mends higher priority use of new drugs such as DPP-4 inhibitors
and long-acting GLP-1 analogs . Use of these agents is associ-
ated with a far lower risk of hypoglycemia because their effects
on insulin stimulation and glucagon suppression are glucose
dependent . Currently available GLP-1 agonists are exenatide
and liraglutide. DPP-4 inhibitors include sitagliptin, linagliptin
and saxaglipin, which are available on the US market. Based on
on going research with these two classes of agents, several new
agents (e.g., alogliptin) will soon be on the market.
Extensive treatment regimens have been developed targeting
hypoglycemia prevention in patients with insulin-deficiency dia-
betes. This includes new technology in both insulin delivery and
glucose sensing, novel glucose-monitoring strategies and better
patient education. Patient education includes instruction on how
to flexibly adjust insulin around changes in diet, exercise, alcohol
ingestion, lifestyle modification and other factors that influence
insulin requirements and sensitivity. Although most studies show
that continuous subcutaneous insulin infusion and glucose sensing
can reduce hypoglycemia in Type 1 diabetes, currently available
technology cannot regulate plasma insulin in ways that mimic
normal b-cell function. Complete protection against hypoglyce-
mia remains an elusive goal, especially in insulin-deficiency diabe-
tes patients with recurrent hypoglycemia. New treatment regimens
should be prescribed prudently, however, with less stringent A1C
goals for those patients with advanced age, longer duration of
diabetes, less insulin reserve and other comorbidities (e.g., renal
dysfunction or liver disease). A careful and informed approach to
hypoglycemia prevention can help patients maintain blood glucose
within a relatively narrow range that avoids adverse episodes of
both hypoglycemia and hyperglycemia. Success in these endeavors
will mean longer lives and improved quality of life.
Although studies on the pathophysiology of hypoglycemia have
helped to develop and exploit strategies to reduce the risk of
hypoglycemia without compromising good glycemic control,
details of the mechanisms that cause or control hypoglycemia
remain unclear. During the next 5 years, new agents that act
on glucose-dependent insulin secretion will offer more choices
Economic burden of hypoglycemia in patients with Type 2 diabetes
Expert Rev. Pharmacoeconomics Outcomes Res. 12(1), (2012)
for optimizing metabolic control in Type 2 diabetes patients.
Improved technology for the use of insulin therapy will give
clinicians more options for Type 1 diabetes that will help mini-
mize hypoglycemia risk. New information about glucose-sensing
networks and how they work will provide more opportunities
to clinically address recurrent hypoglycemia in patients with
insulin-deficiency diabetes. A significant current challenge is
translating basic research findings into clinical practice in order
to at least eliminate severe hypoglycemia. This may require new
ways of enhancing counter-regulatory defenses through devel-
opment of treatment regimens that influence glucose sensing or
cerebral and peripheral metabolic processes. Preventing recurrent
severe hypoglycemia should be a major goal of diabetes manage-
ment programs because it is perhaps the greatest current obstacle
to the delivery of optimal glycemic control for patients with
Type 1 or 2 diabetes.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any
organization or entity with a financial interest in or financial conflict with
the subject matter or materials discussed in the manuscript. This includes
employment, consultancies, honoraria, stock ownership or options, expert
testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Liu, Zhao, Hempe, Fonseca & Shi
• Hypoglycemia is a primary obstacle to good glycemic control. Frequent severe hypoglycemia adversely affects diabetes outcome and
quality of life, and is causing a tremendous economic burden to the healthcare systems in the emerging epidemic of Type 2 diabetes.
• Direct medical costs are measured based on medical care utilization and expenditures to treat hypoglycemia (from ~US$188 to
US$2100 per episode, depending on severity and extent of medical care); indirect costs are measured based on loss of productivity
when patients are absent from work (3 or 8.6 productive days per patient, ~US$3169 per patient per year, varying from country to
• Avoiding hypoglycemia remains a top priority in the treatment of Type 2 diabetes. Severe hypoglycemia can have many serious
consequences. Future research should focus on therapies that promote glucose-dependent insulin secretion. Healthcare systems should
be allowed to deliver more individualized care with better glycemic control for patients with Type 2 diabetes.
Papers of special note have been highlighted as:
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