Burdens related to diabetes management in

Italian children, adolescents and young adults

with type 1 diabetes (T1D) in the TEENs study
Andrea Scaramuzza1, Alessandro Salvatoni1, Ivana Rabbone1, Davide Tinti1, Marco Marigliano1, Elena
Prandi1, Barbara Felappi1, Patrizia Patera1, Sonia Toni1, Lorenzo Lenzi1, Stefano Zucchini1, Giulio Maltoni1,
Dario Iafusco1, Francesco Prisco1, Giuseppina Salzano1, Claudia Ventrici1, Adriana Franzese1, Enza
Mozzillo1, Carla Maria Monciotti1, Vittoria Moret1, Gian Vincenzo Zuccotti1, Francesca Cardella1, Marilena
Tumminelli1, Franco Cadario1, Maria Felicia Faienza1, Vincenza Luce1, Nicola Minuto1, Alfonso La Loggia1,
Sabrina Scelfo1, Anna Biscarini1, Lori Laffel2, Catherine Domenger3, Valentino Cherubini1, Stefano Tumini1
1Diabetes

Study Group of the Italian Society for Pediatric Endocrinology and Diabetology (SIEDP/ISPED), Torino, Italy
Diabetes Center, Boston, MA, USA
3Sanofi, Paris, France
2Joslin

Disclosures
ANDREA SCARAMUZZA
Research support: Abbott, Harmonium, Terumo
Speakers Bureau: Eli Lilly, Roche, Sanofi
Board Member/Advisory Panel: Medtronic
Stock/Shareholder: None
Consultant: None
Employee: None
Other: None

TEENs study is sponsored by Sanofi

Background
Despite the recent advances in diabetes
management technologies, the majority of young
patients fail to achieve the recommended glycemic
targets1-3
Effective management of diabetes in youth
places substantial demands upon patients and
families, with many barriers and challenges to
achieving glycemic targets4,5
There is a need to identify
approaches to improve glycemic
control, and reduce burden of care
1. Wood JR, et al. Diabetes Care 2013;36:20357; 2. Petitti DB, et al. J Pediatr 2009;155:66872; 3. Laffel LM, et al. Diabetes 2014;63(Suppl. 1);A1-A102;32-OR;
4. Silverstein J, et al. Diabetes Care 2005;28:186212; 5. Borus JS and Laffel L. Curr Opin Pediatr 2010;22:40511.

Introduction to
TEENs is an international (20 countries), cross-sectional, observational study
aiming to assess T1D management and psychosocial parameters in 5960 youths
in order to identify approaches to optimize glycemic control and outcomes
EUROPE

USA

25 sites
499 patients

(Denmark/France/Germany/
Hungary/Italy/Portugal/Romania/
Russia/Slovenia/Spain/Sweden)
111 sites
2943 patients

MIDDLE EAST/NORTH AFRICA

(Algeria/Jordan/
Lebanon/Morocco)
33 sites
1041 patients

INDIA

LATIN AMERICA

(Argentina, Mexico)
27 sites
470 patients

SOUTH AFRICA

5 sites
507 patients

18 sites
500 patients

in Italy
Included 23 sites with 1009 participants
(one-third of European patients, one-sixth of global patients)
Investigators:

Salvatoni

Plebani

Maffeis
Monciotti

Meschi
Scaramuzza
Bona
Rabbone
Lorini

Zucchini
Biscarini
Cherubini

Toni

Frongia

Tumini (coordinating Center)

Cappa

Faienza

Franzese
Iafusco
Irace
Cardella
La Loggia

Lombardo

Aim: to describe a sample of youth with T1D in Italy and

to evaluate factors related to attaining HbA1c targets

Inclusion criteria
Study centers were required to be providing care on a regular
basis for at least 100 people with T1D (tertiary referral
Centers of the ISPED Italian Society for Pediatric
Endocrinology and Diabetology)
Youth with T1D:
aged 825 years old
diagnosed before the age of 18 years
diagnosed for at least 1 year

with no major change in insulin regimen during the last

3 months

Methods: recruitment and

HbA1c measurements
In Italy, 23 Centres collected data by interview, medical record
review and participant/parent survey from 1009 Italian youths
Patients were recruited sequentially to avoid selection bias
with recruitment ratio of 25%:50%:25% for 3 age groups:
812 y/o (25%)
1318 y/o (50%)
1925 y/o (25%)

HbA1c was measured uniformly (reference 46%) using

A1cNow (Bayer)
HbA1c targets defined as:

<7.5% (<58 mmol/mol) (ISPAD) for ages 812 years and 1318 years1
<7% (<53 mmol/mol) (ADA) for ages 1925 years2

1. Rewers M, et al. Pediatr Diabetes 2009;10(Suppl. 12):7181; 2. American Diabetes Association. Diabetes Care 2011;34(Suppl. 1):S1161.

Methods: perceived diabetes burden

PAID is a self-report questionnaire:
20 items assess emotional responses to diabetes (e.g. anger,
interpersonal distress, frustration with aspects of diabetes1)
Response items rated on a 6-point scale1

PAID-PR is the parent-revised PAID survey

18 items assess parental perceived burden2

Scores range between 0 (no diabetes-related distress) and 100

(significant diabetes-related distress)3,4
Scores >40 usually considered as high distress3,5

Participants (1325 y/o) completed the validated PAID

survey
Parents of youths aged 818 y/o completed the validated
PAID-PR survey
1. Polonsky WH, et al. Diabetes Care 1995;18:75460; 2. Markowitz JT, et al. Diabet Med 2012;29:25630; 3. van Bastelaar KMP, et al. Diabetes Care 2011;34:3205;
4. Miller ST, et al. BMC Public Health 2008;8:70; 5. Hermanns N, et al. Diabetologia 2006;49:46977.

Italy: participant demographics

and treatment characteristics
Age (years), mean (SD)
Female %
Duration of T1D (years), mean (SD)

Overall

812 y/o

1318 y/o

1925 y/o

(N=1009)

(n=330)

(n=490)

(n=189)

14.8 (4.0)

10.4 (1.4)

15.4 (1.7)

20.8 (1.7)

46

44

47

49

7.5 (4.6)

4.8 (2.8)

7.4 (3.8)

12.5 (8.1)

34

28

37

BMI, % overweight or obese*

Participants parent completed
university/higher education, %

21

20

23

18

Participants living with both parents, %

91

92

93

83

Participants using insulin pump, %

23

19

23

29

If using injection/pens, participants

using basal-bolus therapy, %

86

84

84

93

*BMI-for age z-scores in classes for 818 y/o: overweight = 85th percentile, <95th percentile; obese = 95th percentile. BMI in classes for 1925 y/o: overweight
= 25<30; obese 30

Italy: glycemic control HbA1c levels

Overall

812 y/o

1318 y/o

1925 y/o

1009

330

490

189

HbA1c (%),

7.81.2

7.81.0

7.9 1.3

7.61.2

HbA1c levels

meanSD

45

Overall,

40% of patients achieved

HbA1c targets*

Proportion of participants
attaining glycemic targets* (%)

40
35
30
25
20
15
10
5
0
812 y/o
*7.5% (<58 mmol/mol) (ISPAD) for ages 812 years and 1318 years; <7% (<53 mmol/mol) (ADA) for ages 1925 years

1318 y/o

1925 y/o

Italy: diabetes treatment characteristics

and glycemic target attainment
Proportion of participants (%)

At HbA1c target*

> HbA1c target*

100
90
80
70
60
50
40
30
20
10
0

Overall, 40% of
participants in
Italy achieve
glycemic
targets

812 y/o

1318 y/o

1925 y/o

Proportion of participants using pump

Overall
Proportion of
participants
using
injections/pens

812 y/o

1318 y/o

1925 y/o

If using injections/pens, proportion of

participants using basal-bolus therapy

*7.5% (<58 mmol/mol) (ISPAD) for ages 812 years and 1318 years; <7% (<53 mmol/mol) (ADA) for ages 1925 years

Italy: frequency of selfmonitoring of blood glucose levels

Overall

812 y/o

1318 y/o

1925 y/o

(N=1009)

(n=330)

(n=490)

(n=189)

At HbA1c
target*

> HbA1c
target*

At HbA1c
target*

> HbA1c
target*

At HbA1c
target*

> HbA1c
target*

At HbA1c
target*

> HbA1c
target*

Times/day when the

patient checks their
4.9 (1.6) 4.5 (1.7) 5.5 (1.5) 5.2 (1.5) 4.7 (1.6) 4.4 (1.7) 4.0 (1.3) 3.7 (1.4)
blood sugar with a blood
glucose meter, mean (SD)

More frequent self-monitoring of blood glucose

levels may lead to better HbA1c levels

*7.5% (<58 mmol/mol) (ISPAD) for ages 812 years and 1318 years; <7% (<53 mmol/mol) (ADA) for ages 1925 years

Italy: occurrence of
diabetes-related complications
Proportion of participants (%)

Occurrence of acute complications varied by HbA1c

5

At HbA1c target*
> HbA1c target*

4
3

2
1
0
Overall 812 y/o 1318 y/o 1925 y/o Overall 812 y/o 1318 y/o 1925 y/o
Diabetic ketoacidosis

Severe hypoglycemic event

Lower rate of complications occur in participants attaining HbA1c targets,

with the exception of severe hypoglycemia in 1925 y/o
*7.5% (<58 mmol/mol) (ISPAD) for ages 812 years and 1318 years; <7% (<53 mmol/mol) (ADA) for ages 1925 years

Italy: perceived diabetes-related burden

Higher perceived
diabetes-related
burden

Lower perceived
diabetes-related
burden

PAID/PAID-PR scores (CI)

PAID
50
45
40
35
30
25
20
15
10
5
0

PAID-PR

Score >40
indicate high
distress1,2

*
n=659 n=787

Overall

n=314

n=464 n=423

812 y/o

1318 y/o

n=179

1925 y/o

Parents/guardians perceived greater burden than adolescents/young adults

No difference was observed when data were evaluated according to age
*PAID Questionnaire should be completed by children who are between 13 and 25 years of age; PAID-PR Questionnaire should be completed by parents who
have a minor child/teen (<18 years of age)
1. van Bastelaar KMP, et al. Diabetes Care 2011;34:3205; 2. Hermanns N, et al. Diabetologia 2006;49:46977.

Areas of diabetes management the participants

would like to learn more about:
Insulin administration: 25% wanted to learn more about insulin
administration (28% 812 y/o, 25% 1318 y/o, and 18% 1925 y/o) and
adjusting insulin dose (33% 812 y/o, 24% 1318 y/o, and 25% 1925 y/o)
Nutrition: 33% wanted to learn more about nutrition and dietary issues
(28% 812 y/o, 31% 1318 y/o, and 34% 1925 y/o) or counting
carbohydrates (33% 812 y/o, 29% 1318 y/o, and 36% 1925 y/o)
Exercise: >33% wanted to learn about managing blood sugar levels with
exercise (39% 812 y/o, 35% 1318 y/o, and 24% 1925 y/o)

Psycho-social factors (e.g. alcohol, drugs, sex, smoking): information mostly

requested by teens and young adults (6% 812 y/o, 26% 1318 y/o, and
27% 1925 y/o)

Conclusions
Overall, 40% of Italian youths with T1D achieved HbA1c
targets
Participants who did not achieve glycemic targets
experienced a higher occurrence of acute complications
Parents/guardians reported higher perceived burden than
youth
with T1D
Supplementary education and support appear to be needed
to increase the number of patients reaching target HbA1c
Frequent self-monitoring of BG and use of an insulin pump
may lead to improved glycemic control

Acknowledgements
The Italian TEENs physicians, coordinator and the Sanofi
Italian team
Members of the TEENs Steering Committee

TEENs National Coordinators

All TEENs principal investigators and co-investigators

All the patients and families that participated in the study

Sanofi Type 1 Diabetes Team

Thanks for your attention!