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Journal ArticleDOI

Patient/disease features and glycemic targets in type 2 diabetes: Where do we stand?

11 Jan 2016-Acta Diabetologica (Springer Milan)-Vol. 53, Iss: 4, pp 673-675
TL;DR: This work proposed a way to score individual PDFs and investigated the distribution of such scores in a real-life clinical set, addressing the need of a patient-centered approach for the management of hyperglycemia in individuals with type 2 diabetes.
Abstract: Once again in 2015, the ADA and the EASD have opportunely pointed the need of a patient-centered approach for the management of hyperglycemia in individuals with type 2 diabetes (T2DM) [1]. A HbA1c cut off \\7 % has been suggested with more or less stringent targets to be individually pursued according to patient/disease features (PDFs), including: (a) risks associated with hypoglycemia; (b) disease duration; (c) life expectancy; (d) comorbidities; (e) vascular complications; and (f) patient’s attitude. Since the ADA/EASD made clear that scale for such approach ‘‘is not designed to be applied rigidly but to be used as a broad construct to guide clinical decision making,’’ many clinicians will appreciate to be told how to measure the above-mentioned PDFs. We addressed this issue by firstly proposing a way to score individual PDFs and then investigating the distribution of such scores in a real-life clinical set. Data from 400 consecutive out-patients with T2DM attending two research-based hospitals in Central-Southern Italy, ‘‘Casa Sollievo della Sofferenza,’’ Scientific Institute in San Giovanni Rotondo (SGR, n = 200) and ‘‘Sapienza’’ University Policlinico Umberto I Hospital in Rome (Rome, n = 200) were collected. Each of the six ADA/EASD suggested PDF was scored equal to 0 (good), 1 (intermediate) or 2 (poor). Scoring criteria (Table 1) were pre-specified in a collaborative fashion by all authors and then used independently by four authors who are experienced diabetologists (i.e., taking care of[20 patients/week since 10–35 years; AP, SDC in SGR; MF, SM in Rome). Within each hospital, concordance between scores attributed to each single PDF in each patient was observed in more than 95 % cases. In the absence of agreement, the final score was attributed upon confrontation between the two examiners. Mean values attributed to each single PDF were summed to obtain the total individual PDFs score. Patients’ clinical features are summarized in Table 2. Median value of individual PDFs score was 6, with only one patient scoring 0 and no patients scoring 11 or 12. Patients were then grouped according to score 0–2, (n = 41, 10.2 %), 3–4 (n = 85, 21.2 %), 5–6 (n = 136, 34.0 %), 7–8 (n = 111, 27.8 %) and 9–10 (n = 27, 6.8 %), arbitrarily defined as ‘‘very good,’’ ‘‘good,’’ ‘‘intermediate,’’ ‘‘poor’’ and ‘‘very poor,’’ respectively. According to ADA/EASD patient-centered approach, which patients should be targeted to an intensive anti-diabetes therapy (HbA1c\\ 7 %)? Probably, only those with ‘‘very good’’ or ‘‘good’’ PDFs scores? If so, more than twothirds of our patients should be targeted to more relaxed attempts (HbA1c\\ 7.5 % or more). In fact, the majority of study patients had a score ranging from ‘‘intermediate’’ to ‘‘very poor,’’ while only 31.4 % show a ‘‘very good’’ or ‘‘good’’ score. A similar conclusion could have been drawn according to a totally independent ADA suggestion, Managed by Antonio Secchi.

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Summary

  • Once again in 2015, the ADA and the EASD have opportunely pointed the need of a patient-centered approach for the management of hyperglycemia in individuals with type 2 diabetes (T2DM) [1].
  • A HbA1c cut off \7 % has been suggested with more or less stringent targets to be individually pursued according to patient/disease features (PDFs), including: (a) risks associated with hypoglycemia; (b) disease duration; (c) life expectancy; (d) comorbidities; (e) vascular complications; and (f) patient’s attitude.
  • Since the ADA/EASD made clear that scale for such approach ‘‘is not designed to be applied rigidly but to be used as a broad construct to guide clinical decision making,’’ many clinicians will appreciate to be told how to measure the above-mentioned PDFs.
  • Scoring criteria (Table 1) were pre-specified in a collaborative fashion by all authors and then used independently by four authors who are experienced diabetologists (i.e., taking care of[20 patients/week since 10–35 years; AP, SDC in SGR; MF, SM in Rome).
  • Within each hospital, concordance between scores attributed to each single PDF in each patient was observed in more than 95 % cases.
  • In the absence of agreement, the final score was attributed upon confrontation between the two examiners.
  • Mean values attributed to each single PDF were summed to obtain the total individual PDFs score.
  • Patients’ clinical features are summarized in Table 2.

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SHORT COMMUNICATION
Patient/disease features and glycemic targets in type 2 diabetes:
Where do we stand?
A. Pacilli
1
M. Fallarino
2
M. Massa
1
T. Filardi
2
S. De Cosmo
1
S. Morano
2
V. Trischitta
2,3
Received: 22 December 2015 / Accepted: 25 December 2015
Ó Springer-Verlag Italia 2016
Once again in 2015, the ADA and the EASD have
opportunely pointed the need of a patient-centered
approach for the management of hyperglycemia in indi-
viduals with type 2 diabetes (T2DM) [1]. A HbA
1c
cut off
\7 % has been suggested with more or less stringent tar-
gets to be individually pursued according to patient/disease
features (PDFs), including: (a) risks associated with
hypoglycemia; (b) disease duration; (c) life expectancy;
(d) comorbidities; (e) vascular complications; and (f) pa-
tient’s attitude. Since the ADA/EASD made clear that scale
for such approach ‘is not designed to be applied rigidly but
to be used as a broad construct to guide clinical decision
making,’ many clinicians will appreciate to be told how to
measure the above-mentioned PDFs. We addressed this
issue by firstly proposing a way to score individual PDFs
and then investigating the distribution of such scores in a
real-life clinical set.
Data from 400 consecutive out-patients with T2DM
attending two research-based hospitals in Central-Southern
Italy, ‘Casa Sollievo della Sofferenza,’ Scientific Institute
in San Giovanni Rotondo (SGR, n = 200) and ‘Sapienza’
University Policlinico Umberto I Hospital in Rome (Rome,
n = 200) were collected.
Each of the six ADA/EASD suggested PDF was scored
equal to 0 (good), 1 (intermediate) or 2 (poor). Scoring
criteria (Table 1) were pre-specified in a collaborative
fashion by all authors and then used independently by four
authors who are experienced diabetologists (i.e., taking
care of [20 patients/week since 10–35 years; AP, SDC in
SGR; MF, SM in Rome). Within each hospital, concor-
dance between scores attributed to each single PDF in each
patient was observed in more than 95 % cases. In the
absence of agreement, the final score was attributed upon
confrontation between the two examiners. Mean values
attributed to each single PDF were summed to obtain the
total individual PDFs score.
Patients’ clinical features are summarized in Table 2.
Median value of individual PDFs score was 6, with only
one patient scoring 0 and no patients scoring 11 or 12.
Patients were then grouped according to score 0–2,
(n = 41, 10.2 %), 3–4 (n = 85, 21.2 %), 5–6 (n = 136,
34.0 %), 7–8 (n = 111, 27.8 %) and 9–10 (n = 27,
6.8 %), arbitrarily defined as ‘very good,’ ‘good,’ ‘in-
termediate,’ ‘poor’ and ‘very poor,’ respectively.
According to ADA/EASD patient-centered approach,
which patients should be targeted to an intensive anti-dia-
betes therapy (HbA
1c
\ 7 %)? Probably, only those with
‘very good’ or ‘good’ PDFs scores? If so, more than two-
thirds of our patients should be targeted to more relaxed
attempts (HbA
1c
\ 7.5 % or more). In fact, the majority of
study patients had a score ranging from ‘intermediate’ to
‘very poor,’ while only 31.4 % show a ‘very good’ or
‘good’ score. A similar conclusion could have been drawn
according to a totally independent ADA suggestion,
Managed by Antonio Secchi.
S. De Cosmo, S. Morano and V. Trischitta have equally supervised
the study.
& A. Pacilli
pacillia@libero.it
1
Department of Medical Sciences, Scientific Institute ‘Casa
Sollievo della Sofferenza’’, S. Giovanni Rotondo, FG, Italy
2
Department of Experimental Medicine, ‘Sapienza’
University, Rome, Italy
3
Research Unit of Diabetes and Endocrine Diseases, Scientific
Institute ‘Casa Sollievo della Sofferenza’’,
S. Giovanni Rotondo, FG, Italy
123
Acta Diabetol
DOI 10.1007/s00592-015-0833-x

specifically devoted to elderly people ([65 years). In this
subgroup, the ADA recommends a level of HbA
1c
\ 7.5 %
rather than 7 % if patients are otherwise healthy with intact
cognitive and functional status, more relaxed targets are
indicated for elderly with comorbidities (HbA
1c
\ 8.0 %
or even \8.5 %) [2]. Of note, 255 (63.7 %) of our study
patients were in fact C65 years old, a finding which is
similar to that reported in larger epidemiological surveys,
and thus candidates, by the only virtue of age, to a relaxed
HbA
1c
target (\7.5 % or more). Such a proportion is
similar to that obtained by using the PDFs score (68.6 % of
our patients scored as ‘intermediate,’ ‘poor’ or ‘very
poor’ score), thus somehow validating the results obtained
by PDFs score and reinforcing the idea that, in our clinical
set, intensive anti-diabetes therapy is suggestible for a
minority of patients.
Are our findings interpretable in the context of meta-
analyses of trials addressing the impact of intensive glu-
cose lowering therapy on all-cause mortality which
showed, quite unexpectedly, no benefit at all? Probably
yes; in fact, among possible explanations of such coun-
terintuitive negative result is certainly—on one side—the
deleterious role of severe hypoglycemia [3, 4], which is
ineludibly associated with intensive anti-diabetes therapy,
but—on the other side—also the possibility that intensive
treatment should be limited to younger patients, with short
disease duration and lack of major chronic complications
and comorbidities, all patients whose PDFs score would
conceivably be defined as ‘very good’ or ‘good’ by our
scoring method.
Although we recognize that our scoring method does not
derive from objective standardized measurements (espe-
cially the one referring to patient’s attitude, which is only
based on personal judgment of experienced diabetologists),
it is of note that more than 95 % agreement was observed
between the two examiners within the each hospital, thus
internally validating it.
Table 1 Scoring criteria of the
six patient/disease features,
ranging from 0 (good) to 1
(intermediate) or 2 (poor)
Score 0 1 2
Duration of diabetes (years) \5 5–10 [10
Age (years) \45 45–65 [65
or
Life expectancy (years)
a
[10 5–10 \5
Comorbidities Absent Mild
b
Severe
c
Cardiovascular disease
or
Advanced microangiopathy
Absent Present without clinical events Present with clinical events
d
Hypoglycemic episodes Never Moderate Severe
e
Patient’s attitude
f
Good Intermediate Poor
a
According to the risk defined by our previously published risk engine for predicting all-cause mortality in
patients with type 2 diabetes (De Cosmo et al. Diabetes Care 2013; 36:2830–2835. doi: 10.2337/dc12-1906;
also available as a free web-based calculator at http://www.operapadrepio.it/rcalc/rcalc.php): high risk was
given a score equal to 2, intermediate risk equal to 1 and low risk equal to 0
b
Hearing impairment, arthritis, chronic obstructive bronchitis, depression, gastrointestinal and muscu-
loskeletal diseases, obesity
c
Congestive heart failure, hip fracture, tumors, memory or cognitive impairment, vision reduction
d
Myocardial infarction, heart failure, pulmonary edema, stroke, diabetic foot, amputation, blindness,
retinal detachment, nephrosis, acute renal failure, end stage renal disease
e
Requiring assistance of another person to actively administer carbohydrate, glucagon, or other resusci-
tative actions
f
Based on the personal judgment of experienced physicians
Table 2 Clinical features of the 400 study patients with type 2
diabetes
Sex (M/F) 249/151
Age (years) 66.8 ± 10.3
Body mass index (kg/m
2
) 29.0 ± 5.3
Smokers [n (%)] 58 (14.5)
Duration of diabetes (years) 12.8 ± 9.5
Glycated hemoglobin (%) 7.6 ± 1.7
Anti-hyperglycemic therapy
Diet alone [n (%)] 44 (11.0)
Oral antidiabetes drugs [n (%)] 198 (49.5)
Insulin ± oral antidiabetes drugs [n (%)] 88 (39.5)
Anti-hypertensive treatment [n (%)] 314 (78.5)
Anti-dyslipidemic treatment [n (%)] 252 (63.0)
Data are number (n) and percentage (%) or mean ± SD
Acta Diabetol
123

A further limitation of our scoring method, which is
based on the arbitrary assumption of an equivalent role
played by each PDF, is that the contribution of each feature
is not ‘weighted’ according to its own importance in
determining the level of treatment intensiveness. This
might end up to different individual HbA
1c
targeting. For
example, it is conceivable, and probably agreeable, that
individuals with previous major cardiovascular events,
even in the absence of other counter-indications (thus
scoring only 2), should be preferentially targeted to a
relaxed glycemic control. It is worth noting that, under this
scenario (or similar ones), our scoring method, if any,
underestimates the proportion of patients targetable to
more relaxed HbA
1c
levels. In all, though some suggestions
from experienced people have been recently offered [5],
specifically designed prospective studies aimed at objec-
tively addressing the individual weight to be attributable to
each PDF are definitively needed.
In conclusion, despite the above-mentioned limitations,
we believe our present report has the merit of proposing a
method for measuring ADA/EASD suggested PDFs to
eventually be used for pursuing a patient-centered glucose
lowering treatment. According to the proposed method, in
the real-life clinical set of Central-Southern Italy, the
majority of patient attending diabetes clinics from
research-based hospitals seems not to be eligible to inten-
sive anti-diabetes treatments. Additional attempts are nee-
ded to address the generalizability of our finding and to
better shape the specific weight of each single PDF in
determining the degree of intensiveness of anti-diabetes
treatments.
Compliance with ethical standards
Conflict of interest The authors declare that they have no conflict
of interest.
Ethical standard The study was approved by local ethical committee.
Human and animal rights statement All procedures followed
were in accordance with the ethical standards of the responsible
committee on human experimentation (institutional and national) and
with the Helsinki Declaration of 1975, as revised in 2008.
Informed consent statement Informed consent was obtained from
all patients for being included in the study.
References
1. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E,
Nauck M et al (2015) Management of hyperglycemia in type 2
diabetes, 2015: a patient centered approach update to a position
statement of the American Diabetes Association and the European
Association for the Study of Diabetes. Diabetes Care 38:140–149
2. American Diabetes Association (2015) Glycemic targets. Sec. 6. in
standards of medical care indiabetes2015. DiabetesCare 38:S33–S40
3. Yeh JS, Sung SH, Huang PC, Hsu PF, Huang HM, Yang HL, You
LK, Chuang SY, Cheng HM, Chen CH (2015) Hypoglycemia and
risk of vascular events and mortality: a systematic review and
meta-analysis. Acta Diabetol. doi:10.1007/s00592-015-0803-3
4. Nicolucci A, Pintaudi B, Rossi MC, Messina R, Dotta F, Frontoni
S, Caputo S, Lauro R (2015) The social burden of hypoglycemia in
the elderly. Acta Diabetol 52:677–685
5. Cahn A, Raz I, Kleinman Y, Balicer R, Hoshen M, Lieberman N,
Brenig N, Del Prato S, Cefalu WT (2015) Clinical assessment of
individualized glycaemic goals in patients with type 2 diabetes:
formulation of an algorithm based on a survey among leading
worldwide diabetologists. Diabetes Care 38:2293–2300
Acta Diabetol
123
References
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TL;DR: This briefer article should be read as an addendum to the previous full account on the management of hyperglycemia, which described the need to individualize both treatment targets and treatment strategies with an emphasis on patient-centered care and shared decision making.
Abstract: In 2012, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) published a position statement on the management of hyperglycemia in patients with type 2 diabetes (1,2). This was needed because of an increasing array of antihyperglycemic drugs and growing uncertainty regarding their proper selection and sequence. Because of a paucity of comparative effectiveness research on long-term treatment outcomes with many of these medications, the 2012 publication was less prescriptive than prior consensus reports. We previously described the need to individualize both treatment targets and treatment strategies, with an emphasis on patient-centered care and shared decision making, and this continues to be our position, although there are now more head-to-head trials that show slight variance between agents with regard to glucose-lowering effects. Nevertheless, these differences are often small and would be unlikely to reflect any definite differential effect in an individual patient. The ADA and EASD have requested an update to the position statement incorporating new data from recent clinical trials. Between June and September of 2014, the Writing Group reconvened, including one face-to-face meeting, to discuss the changes. An entirely new statement was felt to be unnecessary. Instead, the group focused on those areas where revisions were suggested by a changing evidence base. This briefer article should therefore be read as an addendum to the previous full account (1,2). Glucose control remains a major focus in the management of patients with type 2 diabetes. However, this should always be in the context of a comprehensive cardiovascular risk factor reduction program, to include smoking cessation and the adoption of other healthy lifestyle habits, blood pressure control, lipid management with priority to statin medications, and, in some circumstances, antiplatelet therapy. Studies have conclusively determined that reducing hyperglycemia decreases the onset and progression of …

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"Patient/disease features and glycem..." refers background in this paper

  • ...Once again in 2015, the ADA and the EASD have opportunely pointed the need of a patient-centered approach for the management of hyperglycemia in individuals with type 2 diabetes (T2DM) [1]....

    [...]

  • ...Received: 22 December 2015 / Accepted: 25 December 2015 / Published online: 11 January 2016 Springer-Verlag Italia 2016 Once again in 2015, the ADA and the EASD have opportunely pointed the need of a patient-centered approach for the management of hyperglycemia in individuals with type 2 diabetes (T2DM) [1]....

    [...]

  • ...Data from 400 consecutive out-patients with T2DM attending two research-based hospitals in Central-Southern Italy, ‘‘Casa Sollievo della Sofferenza,’’ Scientific Institute in San Giovanni Rotondo (SGR, n = 200) and ‘‘Sapienza’’ University Policlinico Umberto I Hospital in Rome (Rome, n = 200) were collected....

    [...]

Journal ArticleDOI
TL;DR: An algorithm constructed according to which an estimate of the patient's glycemic target based on individualized parameters can be computed is an additional decision-making tool offered to the clinician to supplement clinical decision making when considering a glycemic targets for the individual patient with diabetes.
Abstract: OBJECTIVE Observations over the past few years have demonstrated the need to adjust glycemic targets based on parameters pertaining to individual patient characteristics and comorbidities. However, the weight and value given to each parameter will clearly vary depending on the experience of the provider, the characteristics of the patient, and the specific clinical situation. RESEARCH DESIGN AND METHODS To determine if there is current consensus on a global level with regard to identifying these parameters and their relative importance, we conducted a survey among 244 key worldwide opinion-leading diabetologists. Initially, the physicians were to rank the factors they take into consideration when setting their patients9 glycemic target according to their relative importance. Subsequently, six clinical vignettes were presented, and the experts were requested to suggest an appropriate glycemic target. The survey results were used to formulate an algorithm according to which an estimate of the patient9s glycemic target based on individualized parameters can be computed. Three additional clinical cases were submitted to a new set of experts for validation of the algorithm. RESULTS A total of 151 (61.9%) experts responded to the survey. The parameters “life expectancy” and “risk of hypoglycemia from treatment” were considered to be the most important. “Resources” and “disease duration” ranked the lowest. An algorithm was constructed based on survey results. It was validated by presenting three new cases to 57 leading diabetologists who suggested glycemic targets that were similar to those calculated by the algorithm. CONCLUSIONS The resultant suggested algorithm is an additional decision-making tool offered to the clinician to supplement clinical decision making when considering a glycemic target for the individual patient with diabetes.

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"Patient/disease features and glycem..." refers background in this paper

  • ...In all, though some suggestions from experienced people have been recently offered [5], specifically designed prospective studies aimed at objectively addressing the individual weight to be attributable to each PDF are definitively needed....

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TL;DR: The findings of this systematic review and meta-analysis of longitudinal follow-up cohort studies support the speculation that hypoglycemia is a risk factor for adverse vascular events and mortality.
Abstract: Hypoglycemia has been associated with adverse outcomes in patients with diabetes and critical illness. However, such associations in these populations have not been systematically examined. We conducted a systematic review and meta-analysis of longitudinal follow-up cohort studies to investigate the associations between hypoglycemia and various adverse outcomes. After removing duplicates and critically appraising all screened citations, a total of 19 eligible studies were included. As demonstrated by random-effects meta-analysis, hypoglycemia was strongly associated with a higher risk of adverse events (HR 1.90, 95 % CI 1.63–2.20; P 0.1). Additionally, a dose-dependent relationship between the severity of hypoglycemia and adverse vascular events and mortality (HR for mild hypoglycemia: 1.68, 95 % CI 1.25–2.26; P < 0.001 and HR for severe hypoglycemia: 2.33, 95 % CI 2.07–2.61; P < 0.001; p for trend 0.02) was observed. Suggested by a bias analysis, the above observations were unlikely to have resulted from unmeasured confounding parameters. This is the first study demonstrating that hypoglycemia was associated with comparable risk ratios in different study populations and various study endpoints, and a trend of a dose-dependent relationship between hypoglycemia severity and adverse events. The findings of this systematic review support the speculation that hypoglycemia is a risk factor for adverse vascular events and mortality.

41 citations


"Patient/disease features and glycem..." refers background in this paper

  • ...Are our findings interpretable in the context of metaanalyses of trials addressing the impact of intensive glucose lowering therapy on all-cause mortality which showed, quite unexpectedly, no benefit at all? Probably yes; in fact, among possible explanations of such counterintuitive negative result is certainly—on one side—the deleterious role of severe hypoglycemia [3, 4], which is ineludibly associated with intensive anti-diabetes therapy, but—on the other side—also the possibility that intensive treatment should be limited to younger patients, with short disease duration and lack of major chronic complications and comorbidities, all patients whose PDFs score would conceivably be defined as ‘‘very good’’ or ‘‘good’’ by our scoring method....

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TL;DR: Elderly patients with type 2 diabetes who reported SH had significantly higher levels of fear of hypoglycemia, lower psychological well-being, and higher diabetes-related distress, according to a nationwide survey conducted in 12 Italian regions.
Abstract: The study aimed to evaluate the frequency of episodes of symptomatic hypoglycemia (SH) in elderly patients with type 2 diabetes and their impact on quality of life. The study was conducted in 12 Italian regions. Participants filled in a questionnaire collecting data on socio-demographic and clinical characteristics and episodes of SH occurred in the last 4 weeks. The questionnaire included validated scales measuring fear of hypoglycemia (FHQ), psychological well-being (WHO-5), and diabetes-related distress (PAID-5). Overall, 1,323 participants were involved (mean age 70.0 ± 8.7, 47.6 % male, disease duration 15.6 ± 11.7, 63.2 % treated with oral agents, 16.9 % with insulin alone, 14.4 % with insulin plus oral agents), of whom 44.6 % reported 1–3 episodes of SH and 23.8 % reported more than 3 episodes. Patients who reported SH had significantly higher levels of fear of hypoglycemia, lower psychological well-being, and higher diabetes-related distress (p < 0.0001 for all the scales). At multivariate analysis, the experience of more than 3 episodes of hypoglycemia was associated with a 13-fold higher risk of high fear of hypoglycemia (aOR = 13.3; CI 95 % 8.4–21.0), an almost 60-fold higher risk of high diabetes-related distress (PAID-5 score ≥40) (aOR = 59.1; CI 95 % 29.2–119.8), and a higher risk of low psychological well-being (WHO-5 <50) (aOR = 1.5; CI 95 % 0.9–2.4). The occurrence of symptoms of hypoglycemia is very common among older adults with diabetes and their presence is associated with an extremely negative impact on quality of life. Minimizing the risk of hypoglycemia represents a high priority in the diabetes treatment of elderly people.

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Q1. What contributions have the authors mentioned in the paper "Patient/disease features and glycemic targets in type 2 diabetes: where do we stand?" ?

In the absence of agreement, the final score was attributed upon confrontation between the two examiners. A similar conclusion could have been drawn according to a totally independent ADA suggestion, Managed by Antonio Secchi.