EJINME-03039; No of Pages 6

European Journal of Internal Medicine xxx (2015) xxxxxx

Contents lists available at ScienceDirect

European Journal of Internal Medicine

journal homepage: www.elsevier.com/locate/ejim

Original article

Management of patients with type 2 diabetes and multiple chronic conditions: A Delphi
consensus of the Spanish Society of Internal Medicine
Javier Ena a,, Ricardo Gmez-Huelgas b, Demetrio Snchez-Fuentes c, Miguel Camafort-Babkowsk d,
Francesc Formiga e, Alfredo Michn-Doa f, Emilio Casariego g,
the Working Group of Diabetes and Obesity of Spanish Society of Internal Medicine
SEMI Diabetes and Obesity Working Group
a
Internal Medicine Department, Hospital Marina Baixa, Alicante, Spain
b
Internal Medicine Department, Hospital Regional Universitario, FIMABIS, Mlaga, Spain
c
Internal Medicine Department, Hospital Nuestra Seora de Sonsoles, vila, Spain
d
Geriatric Unit, Internal Medicine Department, Hospital Clnic, University of Barcelona, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
e
Geriatric Unit, Internal Medicine Department, Hospital Universitari Bellvitge, IDIBELL, Barcelona, Spain
f
Internal Medicina Deparment, Hospital de Jerez de la Frontera, Universidad de Cdiz, Cdiz, Spain
g
Internal Medicine Department, Hospital Lucus Augustis, Lugo, Spain

a r t i c l e i n f o a b s t r a c t

Article history: Aims: To develop consensus-based recommendations for the management of chronic complex patients with type
Received 14 June 2015 2 diabetes mellitus using a two round Delphi technique.
Received in revised form 28 September 2015 Methods: Experts from the Diabetes and Obesity Working Group (DOWG) of the Spanish Society of Internal Medi-
Accepted 19 October 2015 cine (SEMI) reviewed MEDLINE, PubMed, SCOPUS and Cochrane Library databases up to September 2014 to gather
Available online xxxx
information on organization and health care management, stratication of therapeutic targets and therapeutic ap-
proach for glucose control in chronic complex patients with type 2 diabetes mellitus.
Keywords:
Risk assessment
A list of 6 recommendations was created and rated by a panel of 75 experts from the DOWG by email (rst round)
Glycated hemoglobin and by open discussion (second round). A written document was produced and sent back to DOWG experts for clar-
Nursing home ication purposes.
Institutionalization Results: A high degree of consensus was achieved for all recommendations summarized as 1) there is a need to re-
Long-term care design and test new health care programs for chronic complex patients with type 2 diabetes mellitus; 2) therapeutic
Terminal care targets in patients with short life expectancy should be individualized in accordance to their personal, clinical and
social characteristics; 3) patients with chronic complex conditions and type 2 diabetes mellitus should be stratied
by hypoglycemia risk; 4) age and specic comorbidities should guide the objectives for glucose control; 5) the risk of
hypoglycemia should be a key factor when choosing a treatment; and 6) basal insulin analogs compared to human
insulin are cost-effective options.
Conclusion: The assessment and recommendations provided herein represent our best professional judgment based
on current data and clinical experience.
2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

1. Introduction
The prevalence of diabetes continues to increase around the world
and more people with diabetes are suffering from chronic conditions.
A national survey conducted in Spain between 2009 and 2010 showed
an overall prevalence of diabetes mellitus adjusted for age and sex of
Abbreviations: CCM, Chronic Care Model; CGW, Core Working Group; DOWG,
Diabetes and Obesity Working Group; NPH, Neutral Protamine Hagedorn; SEMI, Spanish
Society of Internal Medicine; T2DM, type 2 diabetes mellitus.
Corresponding author at: Internal Medicine Department, Hospital Marina Baixa,
Alicante, Spain. Tel.: +34 966859957.
E-mail address: ena_jav@gva.es (J. Ena).
13.8%; however, in subjects aged 75 years or older, the prevalence of di-
abetes mellitus was 37.4% [1].
Diabetes mellitus is often associated with other chronic conditions in
Western Europe. In the ObEpi survey, such comorbidities included obe-
sity, 43.1%; high blood pressure, 59.1%; dyslipidemia, 59.9%; myocardial
infarction or angina pectoris, 9.7%; revascularization, 7.8%; heart failure,
7.4%; sleep apnea, 8.3%; and osteoarthritis, 10.7% [2]. Other chronic clus-
ters associated with type 2 diabetes are cognitive impairment and de-
pression [3,4], and diverse types of neoplasms such as prostate, breast,
liver, pancreas, bladder and colon cancer [5]. Moreover, the presence
of multiple chronic conditions is intimately related to polypharmacy
and inappropriate therapies with considerable impact on the elderly
health [6].

http://dx.doi.org/10.1016/j.ejim.2015.10.015
0953-6205/ 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Please cite this article as: Ena J, et al, Management of patients with type 2 diabetes and multiple chronic conditions: A Delphi consensus of the
Spanish Society of Internal..., Eur J Intern Med (2015), http://dx.doi.org/10.1016/j.ejim.2015.10.015
2 J. Ena et al. / European Journal of Internal Medicine xxx (2015) xxxxxx

Clinical practice guidelines are usually focused on a single condition
although some of them can provide recommendations for diabetes care
in specic populations [7,8]. Nevertheless, most clinical practice guide-
lines do not consider the underlying scientic evidence, the patient
goals at short- and long-term, or the applicability of the recommenda-
tions for patients with multiple chronic conditions [9].
Patients with multiple chronic conditions account for most outpa-
tient visits and hospitalizations in the general internal medicine depart-
ments. Therefore, in order to elaborate a series of recommendation for
the management of patients with type 2 diabetes and multiple chronic
conditions, a group of experts from the Spanish Society of Internal Med-
icine (SEMI) carried out a literature review using a Delphi technique to
examine an integrated approach for the management of patients with
multiple diseases, from a clinical and public health perspective.
2.3. Delphi surveyrst round
These six statements were proposed for their acceptance by 75 In-
ternal Medicine specialists, selected among the most active members
of the DOWG, having the adequate background and proved expertise
in the topics under discussion. The participation was unrewarded. In
September 2014, according to the Delphi method, the survey was ini-
tially performed through a web platform. Participants should anony-
mously answer the questionnaire scoring the statements in a 5-point
Likert scale (from 1: totally disagree to 5: totally agree). For the analysis
of the consensus, median percentages were considered after clustering
the 5 points into three groups: 1 + 2 disagreement, 3 neither agreement
nor disagreement, 4 + 5 agreement.

Methods 2.4. Delphi surveysecond round

2.1. Study design In the second stage, all 75 specialists were invited to participate in a
plenary session held in Seville in October 17th, where each panelist
We used the Delphi technique, dened as a systematic method of so- from the core working group presented a summary of the literature re-
licitation and collation of the informed judgment on a particular topic view as well as the results of the rst ballot. Then, a second round of
[10]. anonymous voting started during the meeting using an electronic sys-
tem (Televoter LOGOS Av Com s.r.l. Faenza, Italy).
2.2. Participants A minimum agreement of 75% was needed to reach a consensus.

Initially, two project coordinators dened three conceptual points of

debate: (1) organization and health care, (2) stratication of therapeu- 2.5. Post-meeting assessment of draft statements
tic targets and (3) therapeutic approach for the management of chronic
complex patients with type 2 diabetes. Subsequently, six panelists were In January 2015, a document summarizing the consensus statement
independently selected among the SEMI active members, based on their and the main issues raised in the group discussion that followed the pre-
adequate background and proven expertise in the topics reviewed. sentations of each panelist in the plenary session of Seville was drafted
These eight members formed the core working group. and sent to all participants for review and approval. The nal statement
Panelists searched MEDLINE, SCOPUS and Cochrane Library data- document collects recommendations which represent the best criteria
bases from January 1966 to September 2014 using the following search of the consensus panel, based on their expertise and the relevant litera-
criteria chronic disease, comorbidity, diabetes mellitus, disease manage- ture revised.
ment, elderly, end of life care, glycated hemoglobin, health care, hypoglyce-
mia, institutionalization, long-term care, nursing home, quality-adjusted
life years, risk assessment, terminal care, type 2 diabetes mellitus. Results
After a careful review of the literature identied, the panelists pro-
posed two statements per each area of debate, summarizing controver- 3.1. Delphi surveyrst round
sial or unsolved questions related to the topics to be discussed. The
topics and statements proposed for discussion were: In the rst ballot performed online, all 6 statements, evaluated by a
total of 55 participants (73% of the selected specialists), reached and
Organization and health care for patients with type 2 diabetes and
widely surpassed the minimum percentage needed for consensus
multiple chronic conditions
(Fig. 1).
1 The current health care process needs to be redesigned to adequately
manage chronic patients with multiple diseases.
2 For hospitalized patients with short life expectancy, health care proto-
cols allowing the individualized treatment of type 2 diabetes are needed.

Stratication of therapeutic targets in patients with type 2 diabetes

and multiple chronic conditions
3 For diabetic patients with multiple chronic conditions, stratication
based on the risk of hypoglycemia is essential for the overall assess-
ment of the patient.
4 If patients with short life expectancy are excluded, a specic control
target must be established for diabetic patients with multiple chron-
ic conditions, based on their age and comorbidities.

Therapeutic approach for patients with type 2 diabetes and multiple

chronic conditions
5 The risk of hypoglycemia should be a key factor when choosing ap-
propriate drugs to control blood glucose in elderly patients with ad-
vanced comorbidities. Fig. 1. Results of rst-round of the Delphi survey. Percentage of voters scoring the six state-
6 Basal insulin analogs are cost-effective options compared to human ments who were divided into three groups: 1 + 2 disagree, 3 neither agree nor disagree
insulin. (NA/ND), 4 + 5 agree.

Please cite this article as: Ena J, et al, Management of patients with type 2 diabetes and multiple chronic conditions: A Delphi consensus of the
Spanish Society of Internal..., Eur J Intern Med (2015), http://dx.doi.org/10.1016/j.ejim.2015.10.015
 J. Ena et al. / European Journal of Internal Medicine xxx (2015) xxxxxx
3.2. Delphi surveysecond round
According to the methodology of the project, a new questionnaire
should have been prepared in order to redene the statements not hav-
ing reached the agreement in the rst ballot to be voted during the
meeting plenary session. Due to the results obtained, the core working
group decided to pose the same questionnaire to vote after the presen-
tation and debate of the topics. Hence, the six statements were again
anonymously voted during the plenary session by 58 attendees (77%
of the selected specialists) (Fig. 2). Considering the percentages of
agreement (points 4 + 5), all six statements remained well over the re-
quired 75%. Three statements (2, 3 and 4) had a better score and the
other three (1, 5 and 6) had a slightly lower score (Fig. 3).
Discussion
We used a Delphi method to obtain consensus for best practices on a
range of topics related to the management of patients with type 2 diabe-
tes and multiple chronic conditions. The following provides a descrip-
tion of the presentations made on the topics for discussion.
4.1. The current health care process needs to be redesigned to adequately
treat chronic patients with multiple diseases
The Chronic Care Model (CCM) is a systematic approach designed in
1996 with the aim of improving the care of chronically ill patients. It ad-
vocates in favor of a productive interaction between trained health care
providers and actively informed patients. More than a reproducible spe-
cic intervention, CCM is a reference point in which various worldwide
organizations base their strategies and programs for improving the sys-
tem of chronic illness care. It has six major components: health care or-
ganization, community resources, patient self-management support,
clinical information systems, delivery system design and decision sup-
port [11,12].This literature review has been complex due to the variabil-
ity and inaccuracy in the multimorbidity denitions, type of programs
and results considered. We have identied a huge number of different
programs based on the CCM. Each program has its specic characteris-
tics, considering the country, community and health system idiosyncra-
sy; although they have common points, including most of the
aforementioned and other actions such as stratifying the population
by level of risk and focusing the actions on the most vulnerable people,
performing comprehensive integrated patient's assessments and per-
sonalized care plans, promoting the involvement of multidisciplinary
teams and fostering the continuity of care and transition management.
Fig. 2. Results of second-round of the Delphi survey. Percentage of voters scoring the six
statements who were divided into three groups: 1 + 2 disagree, 3 neither agree nor dis-
agree (NA/ND), 4 + 5 agree.
Please cite this article as: Ena J, et al, Management of patients with type 2 diabetes and multiple chronic conditions: A Delphi consensus of the
Spanish Society of Internal..., Eur J Intern Med (2015), http://dx.doi.org/10.1016/j.ejim.2015.10.015
3
Fig. 3. Percentages of participants who agreed on the six statements in the rst- and sec-
ond-round.
However few studies have rigorously evaluated the effectiveness of
this approach and their results suggest that interventions improve
some outcomes [1315].
Despite the scant evidence on the effectiveness of the current pro-
grams in multimorbidity patients, we consider reasonable the need of
redesigning the health care process by coordinating professionals and tai-
loring the care to the patients' goals. Any reform should start with a pilot
phase and be carried out following a plandocheckact (PDCA) model
which enhances the continuous and dynamic process of improvement
[16].
4.2. For hospitalized patients with short life expectancy, health care proto-
cols allowing the individualized treatment for type 2 diabetes are needed
The possibility of T2DM patients being institutionalized is high. Differ-
ent studies show a prevalence of 2630% diabetics in geriatric residences
[17].
Institutionalized T2DM patients differ from community diabetics in
their higher risk of comorbidities as well as other complications such
as functional disabilities, cognitive impairment, hypoglycemia, malnu-
trition, fall as well as other problems related to the geriatric syndrome.
This situation makes the treatment and care of these patients difcult
which often leads to frailty and reduced life expectancy [18].
Nursing homes and hospitals seem to be the ideal setting for opti-
mizing the most appropriate treatment for any individual patient. In
residents with diabetes it is important to address the prevention of hy-
poglycemia, metabolic complications, infections and hospitalizations, as
well as the introduction of end-of-life care in a timely manner [19]. This
approach should vary based on life expectancy once a detailed assess-
ment of the patient's overall condition has been done. In patients with
a chronic complex status and a life expectancy lower than 612 months,
the aim should be to avoid symptomatic hyperglycemia (N 270 mg/dl)
and minimize hypoglycemia while reducing most concomitant drugs
[20]. On the other hand, chronic complex T2DM patients at the end of
life, but with a higher life expectancy, should be carefully assessed to de-
termine comorbidities, functional and cognitive status and frailty [21].
Interventions must focus on the needs of this population, prioritizing
the patients' quality of life [22]. The diabetes control may be less strin-
gent (HbA1c 7.58.5%) while it is important to maintain a proper hydra-
tion and protein intake, monitor diabetes-related complications and
rationalize the pharmacotherapy considering the risk/benet balance
[23,24].
In conclusion, therapeutic measures for institutionalized patients
with short life expectancy must be individualized in accordance with
their personal, clinical and social characteristics.
4 J. Ena et al. / European Journal of Internal Medicine xxx (2015) xxxxxx
4.3. For diabetic patients with multiple chronic conditions, stratication of
the hypoglycemia risk is essential for the overall assessment of the patient
Again, this literature search has been difcult due to the variability, in-
accuracy of denitions on multicomorbidity and the lack of specic scales
for assessing the risk of hypoglycemia in complex chronic patients.
Age and multicomorbidities are closely related, especially in the
T2DM population. Elderly patients with multiple conditions may fall
within the frailty denition, which increases the risk of physical and
cognitive impairment and death. It is known that elderly patients are
at an increased risk of hypoglycemia [25], an important risk factor for
morbidity and mortality, which is associated with reduced quality of
life, increased health care costs, and poor adherence to treatment [26].
Other factors associated with hypoglycemia in T2DM are the nutritional
status, cognitive function, self-care ability and medications. Therefore, it
is important to develop tools to measure frailty, to identify variables as-
sociated with hypoglycemia as well as risk predictors, in order to help in
the decision-making process concerning clinical management, dis-
charge plan, and follow-up of patients [27,28].
In this context, the Multidimensional Prognostic Index (MPI) has
been constructed upon the information obtained from a Comprehensive
Geriatric Assessment (CGA) that included clinical, functional, cognitive,
nutritional, and social parameters, and was validated for stratifying hos-
pitalized elderly patients into groups at various risks of mortality [25]. A
recent study has concluded that stratifying elderly diabetic patients
using the MPI can be useful for identifying patients at risk who may
need individualized treatment [29].
In spite of the scarcity of data, the available evidence shows that a
global evaluation of multimorbid elderly patients could help us in
selecting those that could benet from a tailored treatment, reducing
or avoiding the risk of hypoglycemia.
4.4. If patients with short life expectancy are excluded, a specic control tar-
get must be established for diabetic patients with multiple chronic condi-
tions, based on their age and comorbidities
The morbi-mortality results obtained from several interventional
studies suggest that aggressive glucose management is not always ben-
ecial [30]. This has lead to a change in the paradigm the lower, the
better. In 2009, ADA Standards of Medical Care in Diabetes recom-
mended less stringent HbA1c goals for patients with specic character-
istics, such as limited life expectancy, extensive comorbid conditions or
a history of severe hypoglycemia [20]. In 2011 and for the rst time, the
Spanish Society of Diabetes (SED) published recommendations which,
taking into account the available evidence, suggested the individualiza-
tion of treatment based on the characteristics of each patient [31]. Now-
adays, it is broadly accepted that the objectives of glucose control
should consider patient frailty and the presence of comorbidities [32,
33]. The most recent joint proposal of the American Diabetes Associa-
tion (ADA) and the European Association for the Study of Diabetes
(EASD) establishes specic recommendations for different diabetic pop-
ulations, including but not limited to comorbidities, disease duration,
vascular complications, risk associated with hypoglycemia or age [30].
The literature search made in this context has shown the scarcity of
clinical trials focused on multimorbid T2DM patients. Hence, our argu-
ments should be based on the main good clinical practices (GCP) [27,
3436], as well as the specic recommendations for elderly patients [31,
3739].
4.5. The risk of hypoglycemia should be a key factor when choosing medica-
tions for blood glucose control in elderly patients with advanced
comorbidities
The revised guidelines emphasize the need of individualizing goals
and treatment strategies according to patients' characteristics such as
age, risk of hypoglycemia, life expectancy, advanced complications or
Please cite this article as: Ena J, et al, Management of patients with type 2 diabetes and multiple chronic conditions: A Delphi consensus of the
Spanish Society of Internal..., Eur J Intern Med (2015), http://dx.doi.org/10.1016/j.ejim.2015.10.015
comorbid conditions [27,3133]. However there are few guidelines ad-
dressing the management of specic comorbidities, especially in the el-
derly population, who represent the majority of chronic complex patients.
The presence of long-term comorbidities is associated with
polypharmacy and higher risk of undesirable effects. In the treatment
of elderly diabetics with comorbidities, short life expectancy or frailty,
the choice of glucose lowering regimens should search for improving
the quality of life and ensuring the patient's safety, minimizing the
risk of adverse effects [36]. Hypoglycemia is regarded as an independent
risk factor for adverse outcomes in elderly T2DM patients [26]; it may
lead to lethal arrhythmias, falls caused by dizziness, confusion, or infec-
tion as a consequence of aspiration during sleep. Hence, in patients at
risk, the selection of hypoglycemic agents should favor those with less
risk of precipitating such event [27].
Chronic kidney disease, highly frequent in T2DM, increases the risk
for hypoglycemia. When choosing hypoglycemic agents, a dose reduc-
tion of drugs with renal excretion must be considered as well as a thor-
ough assessment of their contraindications. In patients with severe
hepatic disease, the use of sulfonylureas or insulin secretagogues can in-
crease the risk of hypoglycemia. On the other hand, hypoglycemia may
exacerbate myocardial ischemia and may cause lethal arrhythmias [40],
thus, drugs with these adverse effects should be avoided in patients
with coronary artery disease. In patients with heart failure, glitazones
are contraindicated and secretagogues should be used with caution
due to the risk of hypoglycemia.
In conclusion, there is sufcient evidence that the risk of hypoglyce-
mia and related-complications, especially in elderly patients with long-
term comorbidities, should condition the choice of an appropriate hypo-
glycemic treatment.
4.6. Basal insulin analogs are cost-effective options compared to human
insulin
The cost of the T2DM therapy has increased signicantly over the
last decade, partly because of the higher patient survival and an in-
creased willingness to use insulin due to the more convenient adminis-
trations the newer presentations offer as well as a better patient
education. Insulin analogs provide some advantages over human insu-
lin: fewer injections which favor treatment adherence, less fear of
dose adjustments, more exibility in the administration times and
user-friendly injection devices. In addition, the decrease in hypoglyce-
mia events and inpatient hospital costs has also a positive impact on
pharmacoeconomics [41]. Various studies have analyzed the cost-
effectiveness of insulin analogs compared with conventional insulin.
Cameron et al. [42] did not prove that the routine use of insulin analogs
was cost-effective in all diabetic patients, although their use may prove
to be cost-effective for those at high risk of hypoglycemia. For his side,
Davidson [43] shares this idea and concludes that insulin analogs only
provide benets in patients with nocturnal hypoglycemia.
The National Institute for Clinical Excellence (NICE) considers that
insulin glargine is likely to be cost-effective in subjects requiring more
than one dose of Neutral Protamine Hagedorn (NPH) insulin, in those
who require assistance with their insulin injections or in those present-
ing with NPH-related hypoglycemia [44]. Also, in Spain, a retrospective
cost-utility analysis performed from the perspective of the Spanish
Health System concluded that insulin glargine is more efcient, pro-
duces less hypoglycemic events and has a better control of HbA1C levels
than NPH insulin [45].
Based on the available data we consider that basal insulin analogs
should be considered cost-effective in T2DM complex patients where
hypoglycemia is associated with a high risk of complications.
4.7. Strengths and limitations
The Delphi method has shown its robustness in providing valid con-
sensus ndings. All six statements discussed reached a consensus. The
 J. Ena et al. / European Journal of Internal Medicine xxx (2015) xxxxxx
study sample had a high percentage of academically engaged specialists
in internal medicine whose opinions did not differ greatly from those of
specialists without academic involvement.
4.8. Conclusion
This expert panel has reached a consensus regarding the need for a
tailored health care process to treat patients with diabetes and chronic
diseases, the individualization of treatment for patients with short life
expectancy, the stratication of hypoglycemia risk in the overall assess-
ment, the addition of age and multiple chronic conditions as factors to
establish therapeutic targets, and the addition of the risk of hypoglyce-
mia as a key factor for selecting blood glucose lowering drugs. The as-
sessment and recommendations provided herein represent our best
professional judgment based on current data and expertise.
5. Learning points
There is a need for health services to conduct more research in pa-
tients with multiple chronic conditions and T2DM.
Underlying diseases, life expectancy and patient preferences should
be considered when selecting therapeutic targets for glucose control
in patients with type 2 diabetes mellitus and multiple chronic condi-
tions.
The use of therapies with low risk of hypoglycemia should be a
major consideration for selecting drug regimens.
Funding support
Boehringer Ingelheim and Lilly Laboratories Alliance. The funds facil-
itated the meeting of the panel of experts. Boehringer Ingelheim and
Lilly Laboratories Alliance had no role in the study design, or data collec-
tion, analysis and interpretation; or in the writing of the report or in the
decision to submit the article for publication.
Statement of human and animal rights
Non applicable
Conict of interests
The authors state that they have no conicts of interest
Acknowledgments
We acknowledge Roco Ibez and Arantxa Garca Boehringer
IngelheimLilly Alliance for supporting the initiative and to Maribel
Ruiz for the SEMI Working Group and meeting coordination. Medical
writing assistance has been provided by Dr. Eliana Mesa, from Anaile
MC, and funded by Boehringer IngelheimLilly.
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Please cite this article as: Ena J, et al, Management of patients with type 2 diabetes and multiple chronic conditions: A Delphi consensus of the
Spanish Society of Internal..., Eur J Intern Med (2015), http://dx.doi.org/10.1016/j.ejim.2015.10.015