uc201001158ee 1 csii-related studies presented during diabetes conferences in 2008 compiled by dr...
Post on 19-Dec-2015
216 views
TRANSCRIPT
1UC201001158EE
CSII-related studies presented during
diabetes conferences in 2008
Compiled byDr Andreas Thomas, Germany
DDG Munich DDG Munich
ADA San Francisco ADA San Francisco
EASD RomeEASD Rome
ISPAD Durban, South AfricaISPAD Durban, South Africa
ATTD PragueATTD Prague
UC201001158EE
2UC201001158EE
Studies using CSII (1):
Use made of available insulin pump functions
Duration of insulin action following basal rate suspension in insulin pump therapy
Comparison of CSII and MDI in treatment of patients with type 1 diabetes
Comparison of CSII and MDI in pregnant women with type 1 diabetes
Effect of CSII on glycemic control and quality of life in patients with type 1 diabetes
Impact of CSII treatment of inflammatoric parameter hs CRP on children with type 1 diabetes
Success of CSII in children of different ages with type 1 diabetes
Contents: studies from 2008 diabetes conferences
UC201001158EE
3UC201001158EE
Studies using CSII (2):
Insulin pump therapy in children with type 1 diabetes
CSII in toddlers from the onset of type 1 diabetes: a five-year follow up study
Bolus management in pediatric patients on insulin pump therapy
Effects of CSII on long-term glycemia in children and adolescents with type 1 diabetes
Impact of bolus management of glycemic control on children with type 1 diabetes
Optimum bolus management following a pizza meal in children and adolescents with type 1 diabetes
Contents: studies from 2008 diabetes conferences
UC201001158EE
4UC201001158EE
Studies using CSII (3):
Algorithm for diabetes management based on real-time continuous glucose monitoring
Cost-effectiveness analysis of CSII and MDI in patients with type 1 diabetes
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
Short-term use of CSII after type 2 diabetes has been diagnosed
Quality of life and treatment satisfaction with CSII
Fulfilment of expectations with CSII therapy
Impact of CSII on cost of treating pediatric patients with type 1 diabetes
Contents: studies from 2008 diabetes conferences
UC201001158EE
5UC201001158EE
Aim of study:
Compare glycemic control, frequency and severity of hypoglycemic episodes and quality of life achieved by two modes of insulin delivery (i.e. CSII and MDI) in ‘clinical practice’ conditions.
Comparison of CSII and MDI in treatment of patients with type 1 diabetes
Myneni, A. et al.: Comparison of insulin infusion pumps versus basal/bolus insulin injections for treatment of type 1 diabetes mellitus in clinical practice. 68th ADA Scientific Session 2008, San Francisco, 2016-PO, Diabetes 2008; 57 (Suppl. 1), A556
UC201001158EE
6UC201001158EE
Myneni, A. et al.: ADA 2008
Method and study group: • Randomized, controlled trial over a two-year period after an initial period
of six months to allow stability for each regimen: CSII with Lispro or Aspart and MDI with Lispro / Glargine or Aspart / Glargine.
• Study parameters in a ‘clinical practice’ setting: - glycemic control (HbA1c)
- hypoglycemic episodes (mild or severe) - Life satisfaction, impact and diabetes-related worries*
• 107 patients with type 1 diabetes:
*Based on DQOL diabetes quality of life questionnaire
Group CSII (n = 53) MDI (n = 54)
Gender 34 f / 19 m 16 f / 38 m
Age (years) 43.2 + 4.2 46.6 + 3.6
Duration of diabetes (years)
23.5 + 3.3 20.7 + 3.6
Comparison of CSII and MDI in treatment of patients with type 1 diabetes
UC201001158EE
7UC201001158EEMyneni, A. et al.: ADA 2008
Findings after two years:
7.45 + 0.25
8.14 + 0.36
6
7
8
9
Hb
A1c
(%)
Comparison of HbA1c Frequency of severe hypoglycemia*
*Assistance required
MDI CSII
0.49 + 0.14
0.25 + 0.12
0
0.2
0.4
0.6
Hy
po
gl.
rate
(p
er
pa
t. y
ea
r)
MDI CSII
p = 0.003 p = 0.013
Comparison of CSII and MDI in treatment of patients with type 1 diabetes
UC201001158EE
8UC201001158EEMyneni, A. et al.: ADA 2008
Findings after two years:
DQOL score (safety of treatment)
MDI CSII
2.54 + 1.44
2.06 + 1.18
0
1
2
3
DQ
OL
sco
re
be
tte
r
Comparison of CSII and MDI in treatment of patients with type 1 diabetes
Lower score indicates higher life satisfaction
DQOL: Diabetes quality of life questionnaire
UC201001158EE
9UC201001158EE
Myneni A et al.: ADA 2008
Conclusions:
CSII therapy is associated with improved glycemic control, fewer episodes of severe hypoglycemia and greater life satisfaction as compared with MDI in a routine clinical practice. Patients using CSII are less worried about their treatment.
Comparison of CSII and MDI in treatment of patients with type 1 diabetes
10UC201001158EE
Use made of available insulin pump functions
Aim of study:
Verify CSII-treated patients’ awareness of the potential of modern insulin pumps. Assess the frequency of use of individual functions in a diabetes centre.
Jankovec, Z. et al.: Frequency of available insulin pump functions use by patients with diabetes mellitus. Abstract 112, 1st ATTD Meeting, Prague 2008
11UC201001158EE
Use made of available insulin pump functions
Jankovec Z et al.: Abstract 112, 1st ATTD Meeting, Prague 2008
Method and study group: • Survey of CSII-treated patients in a diabetological center treating 100
patients with the aid of CSII• Respondents asked about their knowledge of available CSII functions
and frequency of use of the following functions:- temporary basal rate- various basal profiles- extended Bolus- Bolus calculator - remote control
• Questionnaires completed for 87 patients; (43% f / 57% m)• Age: 44.4 + 14.84 years
12UC201001158EE
Use made of available insulin pump functions
Jankovec, Z. et al.: Abstract 112, 1st ATTD Meeting, Prague 2008
Findings: frequency of use of functions
Function Frequency % of patients using function
Average frequency of insulin bolus administration
4.06 + 1.09 per 24 hrs 100%
Extended bolus 19.38 + 32.38 per month 44%
Insulin bolus calculation 5.33 + 3.06 per week 54%
Selection from two or more basal profiles
6.38 + 4.17 per month 49%
Temporary adjustments to basal increment
11.75 + 21.65 per month 57%
Display backlight 11.31 + 21.65 per week 86%
Remote control 18.39 + 18.93 per week 41%
13UC201001158EE
Use made of available insulin pump functions
Jankovec, Z. et al.: Abstract 112, 1st ATTD Meeting, Prague 2008
Findings:
Satisfaction with insulin pump
0% 9% 1% 3% 2%
85%
Dissatisfied, considering ending treatment
Partially satisfied
Dissatisfied, considering switching to different pump
Dissatisfied, but pump is essential for diabetes control
Satisfied, would like insulin pen treatment
Entirely satisfied
14UC201001158EE
17% 21%
26%
6%
30%
10% 16%
28%
4%
42%
Use made of available insulin pump functions
Jankovec, Z. et al.: Abstract 112, 1st ATTD Meeting, Prague 2008
Findings:
Temporary basal ratenon-user, Function not known or not learnt
non-user, Function not known or not learnt
frequent application, very helpful
non-user, function not important
Intermittent use, very helpfuluser, function
not necessary
frequent application, very helpful
non-user, function not important
Intermittent use, very helpfuluser, function
not necessary
Various basal profiles
UC201001158EE
15UC201001158EE
20%
13%
38%
8%21%
0% 22%0%
35%43%
Use made of available insulin pump functions
Jankovec, Z. et al.: Abstract 112, 1st ATTD Meeting, Prague 2008
Findings:
Extended bolus
non-user, Function not knownor not learnt
frequent application, very helpful
non-user, Function not necessary
intermittent application, very helpfuluser,
function not necessary
non-user, Function not known or notlearnt
frequent application, very helpful
non-user, FunctionNot necessary
intermittent application, very helpful
user, function not necessary
Bolus calculator
UC201001158EE
16UC201001158EE
Use made of available insulin pump functions
Jankovec, Z. et al.: Abstract 112, 1st ATTD Meeting, Prague 2008
Findings:
Watertight / splash-resistant pump
10% 8%
57%8%
17%
non-user, unknown function
frequent application, very helpful
non-user, unimportant function
intermittent application, very helpful
user, unnecessary function
11%
46%
13%
30%
non-user, unknown / unlearned function
user, very helpful
non-user, unimportant function
user, unnecessary function
Remote control
17UC201001158EE
Use made of available insulin pump functions
Jankovec Z et al.: Abstract 112, 1st ATTD Meeting, Prague 2008
Conclusions:
Patients welcome technically advanced insulin pumps and most of them use the additional functions. Patients should be taught to use the additional functions; they should also be advised about the use of additional functions as a matter of routine during the management of problems arising during treatment with insulin pumps.
UC201001158EE
18UC201001158EE
Aim of study:
Investigate the time taken to observe a change in glucose concentration following modification of the basal rate. The study has a bearing on predictive pump suspension with the aim of preventing hypoglycemia.
Duration of insulin action following basal rate suspension in insulin pump therapy
Buckingham, B. et al.: Duration of insulin action following pump suspension. 68th ADA Scientific Session 2008, San Francisco, 2019-PO, Diabetes 2008; 57 (Suppl. 1), A557
UC201001158EE
19UC201001158EEBuckingham, B. et al.: ADA 2008
Method and study group: • Determine rate of change (ROC) in blood glucose levels
(mg/dl/min) following discontinuation of basal insulin infusion:
- initial increase in basal rate
- target: glucose level of 80 mg/dl within 30-45 mins
- subsequently suspend basal insulin infusion for 90 mins• Measure rate of change in blood glucose level with FreeStyle
meter (every 10 minutes) and CGM (FS Navigator) • 7 patients with type 1 diabetes
- average age: 27 (range 11-38 years)
Duration of insulin action following basal rate suspension in insulin pump therapy
UC201001158EE
20UC201001158EE
Findings: Rate of change of glucose levels following pump shut-off
Buckingham, B. et al.: ADA 2008
High basalrate
Pump off Normal basal rate
Rat
e o
f ch
ang
e in
glu
cose
(m
g/d
l/m
in)
Time from start of pump shut-off (min)
Basal insulin infusion rates rose by 212% (mean increase) until projected alarm, based on a glucose threshold of 80 mg/dl and a projection horizon of 30-45 mins.
Duration of insulin action following basal rate suspension in insulin pump therapy
UC201001158EE
21UC201001158EE
Conclusions:
The study showed that it takes at least 75 minutes for any change in basal insulin to have a full impact. This is a key factor that needs to be taken into account not just whenever an insulin pump is switched off temporarily, but also for developing algorithms for automated sensor-augmented pump therapy.
Buckingham, B. et al.: ADA 2008
Duration of insulin action following basal rate suspension in insulin pump therapy
UC201001158EE
22UC201001158EE
Aim of study:
Compare effectiveness of CSII and MDI and pregnancy outcomes in pregnant women with type 1 diabetes.
Cyganek, K. et al.: Assessment of continuous subcutaneous insulin infusion versus multiple daily injections of insulin in pregnant women with type 1 diabetes. 68th ADA Scientific Session 2008, San Francisco, 1844-P, Diabetes 2008; 57 (Suppl. 1), A512 and: Hebda-Szydło, A. et al.: The efficacy of continuous subcutaneous insulin infusion and multiple daily injections of insulin in pregnant women with type 1 diabetes. 44th Annual Meeting of EASD 2008, Rome, 1121, Diabetologia 2008; 51 (Suppl. 1), S456-S457
Comparison of CSII and MDI in pregnant women with type 1 diabetes
UC201001158EE
23UC201001158EE
Cyganek, K. et al.: ADA 2008, Hebda-Szydło, A. et al.: EASD 2008
Method and study group: • Controlled observational study
• Measure average blood glucose and HbA1c in each trimester of pregnancy
• Analysis of pregnancy outcomes for both groups • 216 pregnant women with type 1 diabetes:
• MDI: 142 women, age: 28.4 + 6.0 years, duration of diabetes: 11.2 + 7.3 years, proportion of planned pregnancies: 31%
• CSII: 74 women, age: 28.9 + 4.4 years, duration of diabetes: 12.2 + 6.9 years, proportion of planned pregnancies: 59.5 %
Comparison of CSII and MDI in pregnant women with type 1 diabetes
UC201001158EE
24UC201001158EE
Findings:
Change in HbA1c values during pregnancy
5,7 + 1,15,7 + 0,7
6,9 + 1,2 7,0 + 1,6
6,0 + 1,0 5,9 + 0,9
4
4,5
5
5,5
6
6,5
7
7,5
8
Hb
A1c
(%
)
1st trimester 2nd trimester 3rd trimester
p = 0.7 p = 0.03 p = 0.2
CSII MDI
Cyganek, K. et al.: ADA 2008, Hebda-Szydło, A. et al.: EASD 2008
Comparison of CSII and MDI in pregnant women with type 1 diabetes
UC201001158EE
25UC201001158EE
Findings: ComplicationsWeight at birth
Cyganek, K. et al.: ADA 2008, Hebda-Szydło A et al.: EASD 2008
Comparison of CSII and MDI in pregnant women with type 1 diabetes
CSII MDI
3355+725
3437+642
3000
3200
3400
3600
3800
4000
Geb
urt
sgew
ich
t (g
)
Wei
gh
t at
bir
th (
g)
5,6
4,6
1,4
6,3
8,5
4,2
01
23
45
67
89
10
An
teil
(%
)
CSII MDI
n: 1 6 4 12 4 7 Infant death Still birth Congenital malformation
Rat
io w
ith
co
mp
licat
ion
s (%
)
UC201001158EE
26UC201001158EE
Conclusions:
This large observational study produced evidence that the CSII model is superior to an MDI regimen in terms of metabolic control and pregnancy outcomes in women with type 1 diabetes. The slightly better glycemic control significantly decreased the risk of complications for both mother and infant.
Comparison of CSII and MDI in pregnant women with type 1 diabetes
Cyganek, K. et al.: ADA 2008, Hebda-Szydło A et al.: EASD 2008
UC201001158EE
27UC201001158EE
Effect of CSII on glycemic control and quality of life in patients with type 1 diabetes
Aim of study:
Ascertain whether the use of CSII in patients with type 1 diabetes managed by multiple daily injections improves glycemia and meets quality of life (QOL) expectations.
O'Neal, D.N. et al.: Insulin pump therapy (CSII) improves glycaemic control and quality of life in type 1 diabetes. Abstract 153, 1st ATTD Meeting, Prague 2008 UC201001158EE
28UC201001158EE
Effect of CSII on glycemic control and quality of life in patients with type 1 diabetes
O'Neal, D.N. et al.: Abstract 153, 1st ATTD Meeting, Prague 2008
Method and study group: • Assessment of patients with type 1 diabetes (St. Vincent’s Hospital,
University of Melbourne Department of Medicine)
• Analysis of glycemic control (HbA1c)
• Continuous glucose monitoring and analysis of CGM profiles before and after pump initiation
• Measurement of quality of life (QoL) by a diabetes-specific scale after pump initiation
• 44 patients (33 female / 11 male) with type 1 diabetes• Age: 39 + 12 years• Duration of diabetes: 15 + 11 years• BMI: 27.6 + 0.9 kg/m2
• Diabetes complications pre-CSII: 8.9%
UC201001158EE
29UC201001158EE
Effect of CSII on glycemic control and quality of life in patients with type 1 diabetes
O'Neal, D.N. et al.: Abstract 153, 1st ATTD Meeting, Prague 2008
Findings: Change in HbA1c
Pre- 0-4 4-8 8-12 12-16 16-18 18-24 weeks CSIIpump
Hb
A1c
(%)
Ch
ang
e in
Hb
A1c
(%)
fr
om
bas
elin
e
0
-0.2
-0.4
-0.6
-0.8
-1.0
-1.2
8.0
7.5
7.0
7.9 + 1.4 %
7.1 + 1.0 %
UC201001158EE
30UC201001158EE
Effect of CSII on glycemic control and quality of life in patients with type 1 diabetes
O'Neal, D.N. et al.: Abstract 153, 1st ATTD Meeting, Prague 2008
Findings: Proportion of glucose values in various glycemic ranges, measured with CGMS
Hypoglycemia (< 4 mmo/l) Euglycemia (4 - 10 mmo/l) Hyperglycemia (> 10 mmo/l)
Pre- 0-4 4-8 8-12 12-16 16-18 18-24 weeks CSIIpump
Pro
po
rtio
n o
f g
luco
se v
alu
es (%
)
100
80
60
40
20
0
UC201001158EE
31UC201001158EE
Effect of CSII on glycemic control and quality of life in patients with type 1 diabetes
O'Neal, D.N. et al.: Abstract 153, 1st ATTD Meeting, Prague 2008
Findings: patient expectations of CSII
0
10
20
30
40
50
60
70
80
90
100
Part
of
pati
en
ts (
%)
Glucose < 8 mmo/l
Glucose variability
Prevent mildhypo
Prevent severe hypo
PreventDKA
Mealtime flexibility
Physical fitness
Expected Achieved
UC201001158EE
32UC201001158EE
Effect of CSII on glycemic control and quality of life in patients with type 1 diabetes
O'Neal, D.N. et al.: Abstract 153, 1st ATTD Meeting, Prague 2008
Conclusions:
Improved glycemia was observed in patients with type 1 diabetes commencing CSII with CGM, without any increased incidence of hypoglycemia. The quality of life improved with CSII in line with patients’ expectations.
UC201001158EE
33UC201001158EE
Aim of study:
Extensive study of highly sensitive C-reactive protein (hs-CRP) as a marker of chronic inflammation. Plasma levels of over 1 mg/l are considered to represent sub-clinical vasculitis promoting chronic complications. Apart from lowering hyperglycemia, it is important to identify treatment conditions in young patients with type 1 diabetes that could cause CRP to fall below this critical level.
Nuboer, R. et al.: Gradual decrease in hs-CRP during prospective study comparing continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDII). 34th Annual Meeting ISPAD 2008, Durban, WED03, Pediatric Diabetes 2008, 9 (Suppl. 10), 19-20
Impact of CSII treatment of inflammatoric parameter hs-CRP on children with type 1
diabetes
UC201001158EE
34UC201001158EENuboer, R. et al.: ISPAD 2008
Method and study group: • Open, parallel, randomized, controlled, prospective comparative study of
MDII and CSII over a period of 10.5 months:
• 38 pediatric patients with type 1 diabetes• Age: 9.5 ± 3.3 years• Duration of diabetes: 4.4 ± 2.9 years
CSII (n =19) CSII Preference phase
0 3.5 7 10.5 month
Run-in
MDI(n = 38)
MDI (n =19) switch CSII Preference phase
Impact of CSII treatment of inflammatoric parameter hs-CRP on children with type 1 diabetes
UC201001158EE
35UC201001158EE
Findings:
Change in HbA1c
Nuboer, R. et al.: ISPAD 2008
8.34 + 0.93
7.80 + 0.70
7.65 + 0.88
6
7
8
9
Hb
A1c
(%
)
Baseline (MDI) At start of CSII After CSII (3 and 5-7 months) (final MDI values)
p < 0.001
Impact of CSII treatment of inflammatoric parameter hs-CRP on children with type 1
diabetes
UC201001158EE
36UC201001158EE
Findings:
Nuboer, R. et al.: ISPAD 2008
Change in insulin requirement Change in hs-CRP
1.03 + 1.06 0.94 + 0.98
0.76 + 0.86
0
0.5
1
1.5
hs-
CR
P (
mg
/l)
Baseline At start After CSII (MDI) of CSII
p = 0.035
Impact of CSII treatment of inflammatoric parameter hs-CRP on children with type 1 diabetes
1,04+0,351,04+0,29
0,74+0,18
0
0,5
1
1,5
Insu
lin
bed
arf
(IE
/kg
KG
/T
ag)
Baseline At start After CSII (MDI) of CSII
Insu
lin r
equ
irem
ent
(IU
/kg
BW
/day
)
UC201001158EE
37UC201001158EE
Conclusions:
A gradual decrease in CRP was observed during an intensive insulin treatment study, the greatest decrease occurring during CSII. Obviously, CSII also has an effect on CRP levels in patients with type 1 diabetes. Further research is needed.
Comment:The decline in the HbA1c value caused by the use of CSII is not highly significant in comparison with the effects of optimised MDI. The question is, what is the main reason for the decline in hs CRP levels during treatment with CSII? This effect may well be caused by a lower level of glycemic variability. Unfortunately, this was not investigated.
Nuboer, R. et al.: ISPAD 2008
Impact of CSII treatment of inflammatoric parameter hs-CRP on children with type 1 diabetes
UC201001158EE
38UC201001158EE
Success of CSII in children of different ages with type 1 diabetes
Aim of study:
Investigate how pump therapy helps to improve the condition of children with type 1 diabetes, even in those cases in which disease control was poor prior to the use of pump therapy.
Petryaykina, E. et al.: Improvement in HbA1c levels in children and adolescents in the Moscow region with type 1 diabetes after CSII therapy, Abstract 162, 1st ATTD Meeting, Prague 2008and 34th Annual Meeting ISPAD 2008 Durban, WED 37, Pediatric Diabetes 2008, 9 (Suppl. 10), 34
UC201001158EE
39UC201001158EE
Success of CSII in children of different ages with type 1 diabetes
Method and study group:• Switch to CSII in children with poor glycemic control (during
MDI: failure to adhere to diet and insulin therapy regime and also failure to follow doctor’s recommendations)
• Observe glycemic control (change in HbA1c)
• Measure insulin requirement (insulin/body weight) • 85 children with type 1 diabetes (65% female, 35% male)• subdivided into three age groups:
- pre-school age (2-6): n = 11 - primary-school age (7-11): n = 31 - adolescents (12-18): n = 43
• Duration of diabetes: 4.5 + 1.24 years• Average duration of CSII treatment: 1.3 ± 0.25 years
Petryaykina, E. et al.: 1st ATTD Meeting, Prague 2008 and ISPAD 2008UC201001158EE
40UC201001158EE
Success of CSII in children of different ages with type 1 diabetes
Findings:
Change in HbA1c
2–6 years
9.3 + 1.4
10.7 +0.5
9.7 + 0.6 9.8 + 0.8
8.1 + 0.4
7.6 + 0.67.8 + 0.4 7.8 + 0.5
6
8
10
12
Hb
A1c
(%)
Before CSII
With CSII
Before CSII
With CSII
Before CSII
With CSII
Before CSII
With CSII
7–11 years 12–18 years All
Petryaykina, E. et al.: 1st ATTD Meeting, Prague 2008 and ISPAD 2008UC201001158EE
41UC201001158EE
Success of CSII in children of different ages with type 1 diabetes
Findings:
Change in daily insulin requirement
2–6 years
Before CSII
CSII Before CSII
CSII Before CSII
CSII Before CSII
CSII
7–11 years 12–18 years All
Petryaykina, E. et al.: 1st ATTD Meeting, Prague 2008 and ISPAD 2008
0,8
1,1
0,60,7
0,80,7
0,9 0,9
0
0,5
1
1,5
Insu
lin
/ k
g b
od
y w
eig
ht
UC201001158EE
42UC201001158EE
Success of CSII in children of different ages with type 1 diabetes
Conclusions:
The prolonged use of pump therapy in children with a poor record of control helps significantly to improve carbohydrate metabolism and to reduce the insulin dosage per weight ratio.
Petryaykina, E. et al.: 1st ATTD Meeting, Prague 2008 and ISPAD 2008 UC201001158EE
43UC201001158EE
Insulin pump therapy in children with type 1 diabetes
Bolotova, N.V. et al.: Insulin pump therapy in children with type 1 diabetes. Abstract 67, 1st ATTD Meeting, Prague 2008
Aim of study:
Evaluate the effectiveness of insulin pump therapy in children with type 1 diabetes.
44UC201001158EE
Insulin pump therapy in children with type 1 diabetes
Bolotova, N.V. et al.: Abstract 67, 1st ATTD Meeting, Prague 2008
Method and study group:• Two-year observation in an endocrinological centre• Measure glycemic control (i.e. average glucose values,
glucose fluctuations, hypoglycemia rate and insulin requirement)
• 19 children with type 1 diabetes (12 female, 7 male)• Age range: 9-15 years• Duration of diabetes: 1-15 years• Complications: neuropathy: n = 7
angiopathy: n = 4nephropathy: n = 3cardioneuropathy: n = 3retinopathy: n = 1
45UC201001158EE
Insulin pump therapy in children with type 1 diabetes
Bolotova, N.V. et al.: Abstract 67, 1st ATTD Meeting, Prague 2008
Findings:
Glycemic control
9.4 +2.9
11.8 +3.1
7.1 +1.87.7 +2.7
0
2
4
6
8
10
12
14
16
Ave
rag
e b
loo
d s
ug
ar (
mm
ol/l
)
Average morning glucose
Before CSII With CSII
Average bedtime glucose
Variability: • morning glucose
Before CSII: 7.0-16.9 mmol/l
With CSII: 6.0-10.0 mmol/l • bedtime glucose
Before CSII: 5.0-13.2 mmol/l
With CSII: 5.0-10.4 mmol/l
UC201001158EE
46UC201001158EE
Insulin pump therapy in children with type 1 diabetes
Bolotova, N.V. et al.: Abstract 67, 1st ATTD Meeting, Prague 2008
Findings:
Insulin requirement
Before CSII
With CSII
• Variability of insulin requirement:
Before CSII: 0.42 –1.07 IU/kg BW
With CSII: 0.34-0.86 IU/kg BW
0.78 + 0.34
0.57 + 0.41
0
0.2
0.4
0.6
0.8
1
Da
ily in
su
lin d
os
e (
IU)
• Patients with severe hypoglycemias (2-3 per week):
Before CSII: 4
With CSII: 1
UC201001158EE
47UC201001158EE
Insulin pump therapy in children with type 1 diabetes
Bolotova, N.V. et al.: Abstract 67, 1st ATTD Meeting, Prague 2008
Conclusions:
For children with type 1 diabetes, CSII is a highly effective therapy with a high level of user satisfaction, improved glycemic control and reduced insulin dosage. All patients commented on the ease of pump use and increased mobility.
UC201001158EE
48UC201001158EE
Aim of study:
Longitudinal assessment (five-year follow-up) of metabolic control in children under the age of six treated with CSII from the onset of type 1 diabetes.
CSII in toddlers from the onset of type 1 diabetes: a five-year follow-up study
Szypowska, A. et al.: Insulin pump therapy in children under the age of 6 from the onset of type 1 diabetes. A five-year follow-up study. 68th ADA Scientific Session 2008, San Francisco, 1800-P, Diabetes 2008; 57 (Suppl. 1), A499 and Groele, L. et al.: Insulin requirement in children under the age of 6 treated with insulin pumps from the onset of type 1 diabetes mellitus: a five-year follow-up study. 44th Annual Meeting of EASD 2008, Rome, 0989, Diabetologia 2008; 51 (Suppl. 1), S398-S399
UC201001158EE
49UC201001158EESzypowska, A. et al.: ADA 2008, and Groele, L. et al.: EASD 2008
Method and study group : • Insulin pump therapy started within two months of onset of
type 1 diabetes• Measure metabolic parameters every sixth months and after
five years: HbA1c, daily insulin requirement, share of basal rate in daily insulin requirement, and frequency of episodes of diabetic ketoacidosis and severe hypoglycemia
• 58 children (31 girls), under the age of 6 at time of diabetes manifestation (age: 3.3 ± 1.5 years)
CSII in toddlers from the onset of type 1 diabetes: a five-year follow-up study
UC201001158EE
50UC201001158EE
Findings:
Change in HbA1c
Average frequency of episodes of:
• severe hypoglycemia:0.6/100 pat. years• diabetic ketoacidosis:0.6/100 pat. years
ONSET months
3 6 12 18 24 30 36 42 48 54 60
12
10
8
6
4
2
0
Hb
A1
c (
%)
9,6
6,7 7,26,97,3
Szypowska, A. et al.: ADA 2008, and Groele, L. et al.: EASD 2008
CSII in toddlers from the onset of type 1 diabetes: a five-year follow-up study
UC201001158EE
51UC201001158EE
Findings:
month
3 6 12 18 24 30 36 42 48 54 60
30
25
20
15
10
5
0
Pro
po
rtio
n o
f b
asal
rat
e in
DIR
(%
)
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0 Insu
lin
re
qu
irem
ent
(IU
/kg
BW
)
Proportion of basal rate in
daily insulin requirement (DIR )
months
3 6 12 18 24 36 48 54 60
100
80
60
40
20
0
Pro
po
tio
n o
f p
atie
nts
(%
)
Proportion of patients with corresponding share of basal rate in DIR*
Proportion of basal rate: > 35% 25-35% <25% 0%
Szypowska, A. et al.: ADA 2008, and Groele, L. et al.: EASD 2008
CSII in toddlers from the onset of type 1 diabetes: a five-year follow-up study
*Daily insulin requirement
UC201001158EE
52UC201001158EE
Conclusions:
Initiating insulin pump therapy at recognition of type 1 diabetes in children under the age of six results in sustained metabolic control, with a minimal risk of severe hypoglycemia and diabetic ketoacidosis and without any increase in the body mass index. The daily insulin dose increases during type 1 diabetes follow-up to 0.7U/kg BW/d, with 25% basal insulin in total insulin dose.
Szypowska, A. et al.: ADA 2008, and Groele, L. et al.: EASD 2008
CSII in toddlers from the onset of type 1 diabetes: a five-year follow-up study
UC201001158EE
53UC201001158EE
Aim of study:
Determine the long-term effect of insulin pump therapy (CSII) on glycemia in children and adolescents with type 1 diabetes.
Quinn, M. et al.: Impact of pump therapy on long-term glycemia in children and adolescents with type 1 diabetes. 34th Annual Meeting ISPAD 2008, Durban, THU44, Pediatric Diabetes 2008, 9 (Suppl. 10), 56
Effects of CSII on long-term glycemia in children and adolescents with type 1 diabetes
UC201001158EE
54UC201001158EEQuinn, M. et al.: ISPAD 2008
Method and study group :
• Examine the intra-individual changes in mean annual HbA1c in pediatric patients with type 1 diabetes who had used pump therapy for at least two years as part of the Diabetes Programme at the Boston Children’s Hospital
• Observe proportion of patients attaining ADA goals:
<6 years: 7.5-8.5%, 6-12 years: <8%, >13 years: <7.5%• 209 patients (47% girls)
- Age: 11.7 + 4.4 years
- Duration of diabetes: 4.2 + 3.4 years
- Baseline HbA1c: 7.9 + 0.9%
- Number injections during MDI treatment: 30 + 2.7/day
Effects of CSII on long-term glycemia in children and adolescents with type 1 diabetes
UC201001158EE
55UC201001158EE
Findings:
Change in HbA1c before and during CSII treatment
Quinn, M. et al.: ISPAD 2008
- 2 years - 1 year Start of CSII + 1 year + 2 years
Time
8.5
8.0
7.5
7.0
Hb
A1c
(%
)
Effects of CSII on long-term glycemia in children and adolescents with type 1 diabetes
UC201001158EE
56UC201001158EE
Findings:
Proportion of patients (in age groups) attaining ADA goals for HbA1c
Quinn, M. et al.: ISPAD 2008
Effects of CSII on long-term glycemia in children and adolescents with type 1 diabetes
- 2 years - 1 year + 1 year of CSII + 2 years of CSII
0
10
20
30
40
50
60
70
80
90
100
An
teil
Pa
tie
nte
n (
%)
Age: <6 years 6-12 years 13-17 years >18 years All
39 29 15 12 109 102 78 65 59 69 88 84 2 9 28 48 119 122 145 129 n
Pro
po
rtio
n o
f p
atie
nts
(%
)
UC201001158EE
57UC201001158EE
Conclusions:
Pump therapy enabled 43/210 (= 20%) children and adolescents whose HbA1c exceeded target levels on multiple injection therapy to achieve and maintain age-specific HbA1c targets. Optimising the bolus to basal dose ratios is a major contributory factor in achieving the target HbA1c.
Quinn, M. et al.: ISPAD 2008
Effects of CSII on long-term glycemia in children and adolescents with type 1 diabetes
58UC201001158EE
Aim of study:
Investigate effect of meals with different glycemic index on postprandial glucose excursions by varying meal bolus.
Bolus management in pediatric patients on insulin pump therapy
O'Connell, M.A. et al.: Optimising glycaemic control in pediatric patients on insulin pump therapy: the impact of glycaemic index and bolus wave type on postprandial glycaemia. Abstract 152, 1st ATTD Meeting, Prague 2008 and: Optimizing postprandial glycemia in pediatric patients with type 1 diabetes using insulin pump therapy. Diabetes Care 2008; 31 (8): 1491-1495
59UC201001158EE
O'Connell, M.A. et al.: Abstract 152, 1st ATTD Meeting, Prague 2008
Method:
Meals with a high and low glycemic index (GI) have distinct effects on post-prandial glycemia (PPG). PPG excursions may contribute to changes in diabetes-related complications. Insulin pump therapy enables insulin delivery to be tailored to meal composition. Optimum bolus types for meals of varying GI were not defined, however.
Bolus management in pediatric patients on insulin pump therapy
60UC201001158EEO'Connell, M.A. et al.: Abstract 152, 1st ATTD Meeting, Prague 2008
Method and study group:• Test meals with equal macronutrient (CHO, fat, protein), fiber and
energy composition, but opposing GI levels, i.e. 34 v. 76, low GI and high GI
• Subjects eat meals of the same GI on consecutive days. Study group randomized to receive either standard (100%) or dual-wave (50:50 over 2 hours) pre-meal bolus each day
• Measure glucose profiles (CGMS)• 20 children and adolescents with type 1 diabetes and CSII diabetic
patients• Age: 11.3 + 1.8 years (2.3-17.1 years) • Duration of diabetes: 4.9 + 1.9 years (2.1-8.9 years) • Experience of CSII: 0.8 + 0.4 years (0.3-1.8 years)• HbA1c: 7.5 + 0.6% (5.9-8.5%)
• Control group: 10 healthy adults
Bolus management in pediatric patients on insulin pump therapy
UC201001158EE
61UC201001158EE
O'Connell, M.A. et al.: Abstract 152, 1st ATTD Meeting, Prague 2008
Findings: Postprandial glucose profiles after different meals and using different
bolus options (mean deviation in sensor glucose values from baseline)
Low glycemic index
10
5
0
-5-30 0 30 60 90 120 150 180
Time (min.)
Glu
cose
dev
. b
ase
lin
e (m
mo
l/l)
10
5
0
-5-30 0 30 60 90 120 150 180
Time (min.)
Glu
cose
dev
. b
ase
lin
e (m
mo
l/l)
High glycemic index
Standard bolus
Dual bolus
Control
Bolus management in pediatric patients on insulin pump therapy
62UC201001158EE
O'Connell, M.A. et al.: Abstract 152, 1st ATTD Meeting, Prague 2008
Conclusions:
The use of a dual-wave bolus for meals of low glycemic index is associated with significantly less postprandial glycemic excursion than any other meal-bolus combination (45% reduction in postprandial AUC). Hyperglycemic excursions were common after high glycemic index meals. This data supports the use of a dual-wave bolus with low glycemic index meals to optimize postprandial glucose in children with type 1 diabetes on insulin pump therapy.
Bolus management in pediatric patients on insulin pump therapy
63UC201001158EE
Aim of study:
Assess impact of use of dual-wave and square-wave bolus on metabolic control. Estimate ability of pediatric patients to use this system in real life.
Impact of bolus management of glycemic controlon children with type 1 diabetes
Pankowska, E. et al.: Three kinds of mealtime insulin administration and metabolic control in diabetic children on insulin pumps. 44th Annual Meeting of EASD 2008 Rome, 0948, Diabetologia 2008; 51 (Suppl. 1), S381
64UC201001158EEPankowska, E. et al.: EASD 2008
Method: • Cross-sectional prospective study in real-life conditions over two-week
period: • Teach patients to calculate insulin dose per carbohydrate unit (1 CU =
10g CU) and fat-protein unit (1 FPU = 100 kcal fat/protein) with following bolus management:
- normal bolus = insulin ratio x CU- square-wave bolus = insulin ratio x FPU
- prolongation times for FPUs: 1 1 FPU: 3 hours, 2 FPUs: 4 hours, 3 FPU: 5 hours, >3 FPUs: 8 hours
• Measure frequency of dual-wave or square-wave bolus, daily insulin requirement and HbA1c.
Impact of bolus management of glycemic control on children with type 1 diabetes
65UC201001158EEPankowska, E. et al.: EASD 2008
Study group: • 499 children with type 1 diabetes (246 f / 253 m)• Age: 10.60 + 4.14 years• Duration of diabetes: 4.34 + 2.95 years• Age at onset of diabetes: 6.16 + 6.15 years• HbA1c: 7.42 + 1.47%
• Daily insulin requirement: 0.74 + 0.22 IE/day• Share of basal rate in daily insulin requirement:
31.95 + 14.18%
Impact of bolus management of glycemic control on children with type 1 diabetes
66UC201001158EEPankowska, E. et al.: EASD 2008
Findings:
Frequency of dual-wave or square-wave bolus in relation to HbA1c
Average frequency of dual-wave or square-wave bolus: 1.19 + 0.06 per day
Impact of bolus management of glycemic control on children with type 1 diabetes
0,89+0,16
1,39+0,15
0
0,5
1
1,5
2
An
zah
l ve
rl B
oli/
Du
alb
oli
(/T
ag
)
HbA1c < 7.5% HbA1c > 7.5%Fre
qu
ency
of
d-w
or
s-w
bo
lus
/ day
67UC201001158EE
7.82 + 1.69
7.61 + 1.307.42 + 1.47
6
7
8
9
Hb
A1c
(%
)
Pankowska, E. et al.: EASD 2008
Findings:
HbA1c value in relation to frequency of dual-wave or square-wave bolus
0-1 / day 2-3 / day > 3 / day
p < 0.001 p < 0.001
Impact of bolus management of glycemic control on children with type 1 diabetes
68UC201001158EE
Pankowska, E. et al.: EASD 2008
Conclusions: The HbA1c level in patients using at least one dual-wave or square-wave bolus per day is equivalent to the recommended level. Pediatric patients on CSII are able to use dual-wave or square-wave boluses in real-life situations. 18.8% of patients did not use dual-wave or square-wave boluses during the two-week study and had a higher level of HbA1c (7.82% as opposed to 7.32%).
Impact of bolus management of glycemic control on children with type 1 diabetes
69UC201001158EE
Aim of study:
Identify optimum insulin pump meal bolus by comparing postprandial blood sugar levels using six methods of insulin pump meal blousing for a consistent pizza meal.
Optimum bolus management following a pizza meal in children and adolescents with type 1 diabetes
Scaramuzza, A.E. et al.: The optimum type of bolus following a pizza meal in children and adolescents with type 1 diabetes. 44th Annual Meeting of EASD 2008, Rome, 0949, Diabetologia 2008; 51 (Suppl. 1), S381-S382
70UC201001158EEScaramuzza, A.E. et al.: EASD 2008 Rome
Method: • Use bolus management for pizza meals (with the same CHU* value)
on consecutive days:a) Margherita Pizza: Dual-Wave Bolus (30% insulin immediately, 70% over 6-hr
period), given 15 min. prior to meal (GPM)b) Margherita Pizza: Dual-Bolus (30% insulin immediately, 70% over 6-hr period),
given 0 min. prior to meal c) Margherita Pizza: normal bolus (100% insulin immediately),
given 15 min. prior to meal d) Margherita Pizza: normal bolus (100% insulin immediately),
given 0 min. prior to meal e) Vegetable Pizza: Dual-Bolus (30% Insulin immediately, 70% over 6-hr period),
given 15 min. prior to meal f) Vegetable Pizza: Dual-Bolus (30% insulin immediately, 70% over 6-hr period),
given 0 min. prior to meal
• Measure glucose profiles over 6-hr period by measuring blood glucose (SMBG, 30-min. frequency)
• Aspart insulin
Optimum bolus management following a pizza meal in children and adolescents with type 1 diabetes
*Carbohydrate unit
71UC201001158EEScaramuzza, A.E. et al.: EASD 2008 Rome
Study group: • 26 children and adolescents with type 1 diabetes,
treated with CSII • Age: 14.81 + 4.28 (range: 4-22) years• Duration of diabetes: 8.23 + 4.41 (range: 1-19) years• Daily insulin requirement: 0.44 + 0.32 IU /day• BMI: 22.16 + 4.28 kg/m2
Optimum bolus management following a pizza meal in children and adolescents with type 1 diabetes
72UC201001158EE
60
80
100
120
140
160
180
200
220
time (min)
Glu
cose
(m
g/d
l)
0 30 60 90 120 180 240 360
Scaramuzza, A.E. et al.: EASD 2008 Rome
Findings:
Glycemic values following various types of bolus
Dual-Wave 6 hrs, 15 min. prior to Margherita
Dual-Wave 6 hrs, 0 min. prior to MargheritaNormal bolus 15 min. prior to MargheritaNormal bolus 0 min. prior to MargheritaDual-Wave 6 hrs, 15 min. prior to VegetableDual-Wave 0 min prior to Vegetable
Optimum bolus management following a pizza meal in children and adolescents with type 1 diabetes
73UC201001158EE
Scaramuzza, A.E. et al.: EASD 2008 Rome
Conclusions:
The use of a dual-wave bolus during a six-hour period following a pizza meal resulted in significantly less postprandial hyperglycemia during this period, provided that it was given 15 minutes in advance. A normal bolus could be used only if given 15 minutes before consumption of a vegetable pizza. This is despite the fact that a rise in glycemic values was observed during the final two hours of the study.
Optimum bolus management following a pizza meal in children and adolescents with type 1
diabetes
74UC201001158EE
Aim of study:
Identify preconceptions of CSII and their impact on outcomes.
Barnard, K.D. et al.: Do prior expectations affect perceived success/satisfaction with CSII therapy? 68th ADA Scientific Session 2008, San Francisco, 1865-P, Diabetes 2008; 57 (Suppl. 1), A518
Fulfillment of expectations with CSII therapy
75UC201001158EEBarnard, K.D. et al.: ADA 2008
Method and study group: • Participants were recruited via the website of the University
of Southampton’s School of Psychology during a six-month period
• Participants completed a brief web-based questionnaire about their expectations of CSII
• Where their expectations had been met, they were asked what was better and worse about CSII than previous insulin regimens, and any other issues
• 184 participants
Fulfillment of expectations with CSII therapy
76UC201001158EEBarnard, K.D. et al.: ADA 2008
Findings:
Proportion of patients whose expectations of CSII were met
Fulfillment of expectations with CSII therapy
80,0 96,7 76,1
0
20
40
60
80
100
An
teil
Pat
ien
ten
(%
)
All prior expectations
met
CSII significantly better than previous
regimen
CSII exceeded prior expectations
Pro
po
rtio
n o
f p
atie
nts
(%
)
77UC201001158EEBarnard, K.D. et al.: ADA 2008
Findings:
Proportion of patients with concerns before start of CSII therapy
Fulfillment of expectations with CSII therapy
Concerns about insertion
of canula / infusion set
Concerns about psychological implications of being
permanently attached to pump No concerns
49
41
49
0
20
40
60
80
100
An
teil
Pat
ien
ten
(%
)
Pro
po
rtio
n o
f p
atie
nts
(%
)
78UC201001158EEBarnard, K.D. et al.: ADA 2008
Findings:
Number of patients citing disadvantages of CSII
Number of patients citing advantages of CSII
Fulfillment of expectations with CSII therapy
Permanent attachment
to pump
Appea-rance/
visibility of device
Increased blood
glucose testing
16
4335
0
20
40
60
An
zah
l P
atie
nte
n
Nu
mb
er
of
pa
tie
nts
Greater flexibility / improved lifestyle
Better blood
glucose values
Fewer hypo-glycemias
21
110100
0
20
40
60
80
100
120
An
zah
l P
atie
nte
n
Nu
mb
er
of
pa
tie
nts
79UC201001158EE
Fulfillment of expectations with CSII therapy
Barnard, K.D. et al.: ADA 2008
Conclusions:
Despite the quality-of-life benefits said to be associated with CSII therapy, the majority of participants chose CSII for its perceived biomedical benefits e.g. improved diabetes control. A number of participants expected to experience psychosocial benefits, e.g. improved quality of life, greater lifestyle flexibility and greater overall control of their lives as well as biomedical benefits. Very few participants chose CSII purely for psychosocial reasons. Differences in the rationale for choosing CSII, i.e. for the perceived biomedical or psychosocial benefits, did not affect the participants’ degree of satisfaction with CSII, however.
80UC201001158EE
Aim of study:
Compare quality of life and treatment satisfaction among adults with type 1 diabetes, according to the main indication for CSII treatment.
Quality of life and treatment satisfaction with CSII
Franciose, M. et al.: Correlates of quality of life in adults with type 1 diabetes treated with continuous subcutaneous insulin injection. 68th ADA Scientific Session 2008, San Francisco, 0419-P, Diabetes 2008; 57 (Suppl. 1), A125
81UC201001158EEFranciose, M. et al.: ADA 2008
Method and study group:• Patients treated with CSII recruited in 43 Italian diabetes clinics • Patients completed various questionnaires during routine visits:
• DSQOLS (Diabetes-Specific Quality of Life Scale)• DTSQ (Diabetes Treatment Satisfaction Questionnaire )• SF-36 (Health Survey )
• Patients categorised in three groups according to indications for CSII• Group A: poor glycemic control (n = 158)• Group B: unstable glycemia (n = 197)• Group C: others (i.e. dawn phenomenon, desire for greater lifestyle
flexibility, pregnancy, n = 122) • 477 consecutive patients, aged 18-55
Quality of life and treatment satisfaction with CSII
82UC201001158EE
Responses to questionnaires:
Franciose, M. et al.: ADA 2008
Quality of life and treatment satisfaction with CSII
83UC201001158EEFranciose, M. et al.: ADA 2008
Study group:
Indication for CSII Unstable diabetes Poor glyc. control Other
Age (years) 37.0 + 10.8 35.0 + 11.0 32.2 + 10.2
Gender (%) 61.5 f / 38.5 m 60.6 f / 39.2 m 46.7 f / 53.3 m
Duration of diabetes (years) 19.8 + 10.5 18.4 + 9.8 15.9 + 9.5
HbA1c (%) 7.9 + 5.5 8.0 + 1.3 7.1 + 1.1
Complications: 0 1 2 >3
55.1%27.0%11.2%6.6%
54.4%24.7%13.3%7.6%
81.2%15.6%2.5%0.8%
Incidence of severe hypoglycemia / year: 0 1 > 1
73.9%11.1%15.0%
89.9%3.4%6.8%
83.9%7.1%8.9%
Incidence of ketoacidosis / year: 0 > 1
84.3%15.7%
91.1%8.9%
93.4%6.6%
Quality of life and treatment satisfaction with CSII
84UC201001158EE
Findings: Correlation between DSQOLS score and indication for CSII
40
60
80
100
Wer
t
Social
relat
ionsh
ips
Leisu
re tim
e
flexib
ility
Physic
al
com
plaint
s
Wor
ries a
bout
futu
re
Unstable diabetes
Diet re
strict
ions
Day-to
-day
hass
lesCon
cern
s
abou
t
hypo
glyce
mia
Sco
re
Poor glycemic control Other indications
Franciose, M. et al.: ADA 2008
be
tte
rQuality of life and treatment satisfaction with CSII
85UC201001158EEFranciose, M. et al.: ADA 2008
Findings of multivariate linear regression analyses:Comparison between groups*
QoL aspects A v. B (p value)
B v. C (p value)
QoL aspects A v. B (p value)
B v. C (p value)
DSQOLS: social relationships
- 5.1 (0.028)
- 11.1 (<0.0001)
SF-36: physical well-being
--- - 9.2 (0.0027)
DSQOLS: leisure time flexibility
- 7.7 (0.004)
- 10.5 (<0.0001
SF-36: emotional well-being
--- - 14.4 (0.0008)
DSQOLS: physical complaints
- 5.39 (0.016)
- 8.8 (0.0002)
SF-36: energy-vitality
--- - 4.3 (0.018)
DSQOLS: worries about future
- 7.1 (0.02)
- 8.6 (0.004)
SF-36: mental health
--- - 5.97 (0.0013)
DSQOLS: diet restrictions .
--- - 7.0 (0.006)
SF-36:bodily pain - 8.9 (0.0033)
- 7.25 (0.012)
DSQOLS: concerns about hypoglycemia
--- - 7.3 (0.008)
SF-36: social functioning
- 5.7 (0.06)
- 10.9 (0.0002)
SF-36: physical functioning
--- - 2.8 (0.03)
SF-36: mental com-ponent summary
--- - 5.9 (0.0002)
*Group A: poor glycemic control; group B: unstable diabetes; group C: other indications.
Quality of life and treatment satisfaction with CSII
86UC201001158EEFranciose, M. et al.: ADA 2008
Conclusions:
Patients with unstable diabetes, and to a lesser extent those with poor metabolic control, report a particularly poor QoL. They require patient-tailored education and psychological support.
Quality of life and treatment satisfaction with CSII
87UC201001158EE
Approach:
A plausible mechanism to induce long-term remission of patients newly diagnosed with type 2 diabetes after short-term CSII is that the normalization of plasma glucose leads to relief of glucose toxicity and improved pancreatic insulin secretion.
Aim of study:
Determine the impact of short-term CSII on insulin sensitivity and first phase of insulin secretion in newly diagnosed patients with type 2 diabetes.
Yang, Z. et al.: Impact of short-term continuous subcutaneous insulin infusion therapy on insulin sensitivity and insulin secretion in newly diagnosed type 2 diabetes patients. 68th ADA Scientific Session 2008, San Francisco, 0349-OR, Diabetes 2008; 57 (Suppl. 1), A86-A87
Short-term use of CSII after type 2 diabetes has been diagnosed
Tony Parr:
This paragraph does not make sense in English. Can we take a look at it together?
Tony Parr:
This paragraph does not make sense in English. Can we take a look at it together?
88UC201001158EEYang, Z. et al.: ADA 2008
Method: • Prospective investigation with healthy persons and new
diagnosed patients with type 2 diabetes • Realization of hyperinsulinemia euglycemia clamp test
(determination insulin sensitivity, time: 150 min, insulin infusion rate: 1 mU/ kg BW/min, goal: 5 mmol/l) and intravenous glucose tolerance test (determination insulin secretion) before using CSII and follow-up
Short-term use of CSII after type 2 diabetes has been diagnosed
89UC201001158EEYang, Z. et al.: ADA 2008
Study group:
Group Type 2 diabetes (n = 10)
Control (n = 9)
Gender 3 f / 7 m 5 f / 4 mAge (years) 42.7 + 11.3 35.3 + 5.3FBG (mmol/l) 13.5 + 2.9 4.7 + 0.5BMI (kg /m2) 28.8 + 5.6 22.8 + 2.6
Short-term use of CSII after type 2 diabetes has been diagnosed
90UC201001158EEYang, Z. et al.: ADA 2008
Findings in patients with diabetes:
Plasma glucose in IVGTT before and after CSII
Time (min.)
0 1 2 3 5 10
35
30
25
20
15
10
5
0
Glu
cose
(m
mo
l/l)
Time (min.)
0 1 2 3 5 10
35
30
25
20
15
10
5
0
Glu
cose
(m
mo
l/l)
Before CSII After CSII
Short-term use of CSII after type 2 diabetes has been diagnosed
91UC201001158EEYang, Z. et al.: ADA 2008
Findings in patients with diabetes:
Plasma insulin level in IVGTT before and after CSII
Time (min.)
0 1 2 3 5 10
35
30
25
20
15
10
5
0In
suli
n (
mU
/l)
Time (min.)
0 1 2 3 5 10
35
30
25
20
15
10
5
0
Insu
lin
(m
U/l
)
Before CSII After CSII
Short-term use of CSII after type 2 diabetes has been diagnosed
92UC201001158EEYang, Z. et al.: ADA 2008
Findings:
Change in AIR
7.63 + 4.73
0.83 + 1.96
0
2
4
6
8
10
12
AIR
(mU
/min
)
AIR: Acute Insulin Response
Before CSII After CSII
GIR: Glucose Infusion Rate
5.33 + 1.43
8.26 + 2.48
2.30 + 0.81
0
2
4
6
8
10
12
GIR
(mg
/kg
//min
)
Before CSII After CSII Control
Change in GIR
Short-term use of CSII after type 2 diabetes has been diagnosed
93UC201001158EEYang, Z. et al.: ADA 2008
Conclusions:
The normalization of blood glucose levels by transient intensive CSII therapy can improve pancreas ß cell function and insulin sensitivity, both of which may contribute to long-term diabetic remission.
Short-term use of CSII after type 2 diabetes has been diagnosed
94UC201001158EE
Aim of study:
Examine outcomes and cost of continuous subcutaneous insulin infusion (CSII) therapy in pediatric patients with type 1 diabetes.
Impact of CSII on cost of treating pediatric patients with type 1 diabetes
Feltbower, R. et al.: Using insulin pump therapy in the management of insulin-dependent diabetes in childhood: the Leeds, UK, Experience, 34th Annual Meeting ISPAD 2008, Durban, WED34, Pediatric Diabetes 2008, 9 (Suppl. 10), 33
95UC201001158EE
Method and study group: • Examination of data in a pediatric diabetic center (Leeds,
UK): situation 12 months before treatment compared with situation 12 months after start of CSII treatment (2002-2007):
- glycemic parameter (HbA1c)
- frequency of hypoglycemias- frequency of hospitalizations - accumulated cost of treatment
• 83 patients (54% female) with type 1 diabetes • Age 0-18 years • average age: 12 (range 0.3–17.0 years)
Feltbower, R. et al.: ISPAD 2008
Impact of CSII on cost of treating pediatric patients with type 1 diabetes
96UC201001158EEFeltbower, R. et al.: ISPAD 2008
Findings:
Change in HbA1c
8,9+1,5
9,4+1,7
6
7
8
9
10
Hb
A1c
(%
)
Baseline 12 months before CSII after start
of CSII
Age-specific proportion of patients with better HbA1c
Impact of CSII on cost of treating pediatric patients with type 1 diabetes
88
36
77
0
20
40
60
80
100
120
An
teil
Pat
ien
ten
(%
)
<12 years 12-15 years >16 years
Pro
po
tio
n o
f p
atie
nts
(%
)
97UC201001158EEFeltbower, R. et al.: ISPAD 2008
Findings:
HospitalizationCost reduction during
CSII treatment
Impact of CSII on cost of treating pediatric patients with type 1 diabetes
7,59
8,80
7,30
2,40
0
2
4
6
8
10
Ho
spit
alis
ieru
ng
srat
e/10
0 P
J
MDI CSII MDI CSII
Severe Severe hypoglycemia hyperglycemia
Fre
quen
cy o
f ho
spita
liza
tion/
100
PY
-9106
-639
-10000
-8000
-6000
-4000
-2000
0
Ko
sten
sen
kun
g (
bri
t. P
fun
d/1
00P
J)
Severe Severe hypoglyc. hyperglyc.
Dec
reas
e in
cos
t (G
BP
/100
PY
)
98UC201001158EEFeltbower, R. et al.: ISPAD 2008
Conclusions:
Compared with MDI, CSII not only resulted in an improved HbA1c value, but also lowered the cost of treatment. The main reason is a lower frequency of hospitalization due to complications (especially hypoglycemias). The study showed that CSII is a cost-effective treatment option for pediatric patients.
Impact of CSII on cost of treating pediatric patients with type 1 diabetes
99UC201001158EE
Aim of study:
Calculate long-term cost and outcomes of CSII compared with MDI in adult patients with type 1 diabetes, using clinical and cost data published in the USA.
Cost-effectiveness analysis of CSII and MDI in patients with type 1 diabetes
Meaghan, S.C. et al.: A cost-effectiveness analysis of continuous subcutaneous insulin injection v. multiple daily injections in type 1 diabetes patients: a third party USA payer perspective. 68th ADA Scientific Session 2008, San Francisco, 1182-P, Diabetes 2008; 57 (Suppl. 1), A337
100UC201001158EE
Method: • Clinical and cost data published in the USA • Calculate the incremental cost-effectiveness ratio (ICER*) of CSII as compared with
MDI among adult and adolescent patients by using a valid health economic model (CORE model)
• Simulate the progression of diabetes-related complications by using the Markov model
• Characteristics of study group:
Meaghan, S.C. et al.: ADA 2008
Adults Adolescents
MDI CSII MDI CSII
Age (years) 27 27 13 13
Gender (% female) 53.5 53.5 50 50
Diabetes duration (years) 9.0 9.0 5.6 5.6
HbA1c (%) 8.95 8.95 8.2 8.2
BMI (kg/m2) 23.75 23.75 23.75 23.75
*ICER = costsCSII-costsMDI
profitCSII-profitMDI
Cost-effectiveness analysis of CSII and MDI in patients with type 1 diabetes
101UC201001158EE
Underlying assumptions (based on study data):
• Change in HbA1c value with CSII as compared with MDI:
- 0.9% in adolescents1 and - 1.2% in adults2
• Reduction in severe hypoglycemias: 50% with CSII as compared with MDI3
• Average cost per annum of treatment options (assuming a seven-year pump life in the case of CSII):
• Prospective time horizon: 60 years, with costs and clinical outcomes discounted at a rate of 3.0% per annum
Meaghan, S.C. et al.: ADA 2008
Adults Adolescents
MDI USD 3,776.33 USD 3,501.35
CSII USD 5,358.42 USD 5,167.46
1 Doyle et al., Diabetes Care 20042 Weissberg-Benchell et al., Diabetes Care 20033 Bruttomesso et al., Diabetic Med 2002
Cost-effectiveness analysis of CSII and MDI in patients with type 1 diabetes
102UC201001158EE
Findings: • CSII treatment is associated with an improvement in quality-adjusted
life years (QALYs) gained, viz. of 1.061 v. MDI for adults and 0.799 v. MDI for adolescents
• ICER of CSII v. MDI: - USD 16,992/QALY* in adults- USD 27,195/QALY in adolescents
• Factors possibly affecting values:
Meaghan, S.C. et al.: ADA 2008
*Quality-adjusted life year
- change in HbA1c value
- reduced frequency of hypoglycemias- economic life of insulin pump (e.g. four years)
Cost-effectiveness analysis of CSII and MDI in patients with type 1 diabetes
103UC201001158EE
Findings:
Improved glycemic control resulting from CSII treatment led to a lower incidence of complications:
Meaghan, S.C. et al.: ADA 2008
- cumulative incidence of proliferative diabetic retinopathy (- 29%, NNT: 9)
- peripheral vascular disease (- 16%, NNT: 41)- end-stage renal disease (- 20%, NNT: 19)- mortality caused by nephropathy (- 22%, NNT: 21)
NNT – number needed to treat
Cost-effectiveness analysis of CSII and MDI in patients with type 1 diabetes
104UC201001158EE
Conclusions:
If the willingness to pay is set at USD 50,000/QALY, the study showed that CSII is a cost-effective treatment option compared with MDI for both adult and adolescent patients with type 1 diabetes in the USA.
Meaghan, S.C. et al.: ADA 2008
Cost-effectiveness analysis of CSII and MDI in patients with type 1 diabetes
105UC201001158EE
Aim of study: Investigate whether continuous intraperitoneal insulin infusion (CIPII) delivered with an implantable pump is safe and provides equal or superior glycemic control with fewer episodes of hypoglycemia as compared with intensive subcutaneous insulin therapy (SC), multiple dose injections (MDI) and continuous subcutaneous insulin infusion (CSII)) in poorly controlled type 1 diabetes patients.
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
Lotgenberg, S.J. et al.: Marked improvement in glycaemic control, and more time in euglycaemia without increase in hypoglycaemia with CIPII compared to CSII in type 1 diabetes. 44th Annual Meeting of EASD 2008, Rome, 0182, Diabetologia 2008; 51 (Suppl. 1), S81-S82
106UC201001158EE
Method: Continuous intraperitoneal insulin infusion (CIPII) using MIP 2007 C implantable pump (Medtronic)
- Surgery required for implantation- Transdermal insulin refills (concentration:
U400)- No. of worldwide implantations:
approximately 1,000 (including re-explants)
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
107UC201001158EE
Method: • Open-label, randomized, controlled, cross-over trial during 16-month
period: three-month run-in for optimization of insulin therapy Randomization of patients:- six months on either CSII or CIPII - wash-out phase between both options (max. 4 weeks)
• Inclusion criteria: HbA1c >7.5% and/or >5 hypoglycemic events per week
• Outcomes: - HbA1c, value after 3 and 6 months in both phases
- time spent in euglycemia range (4.0–10.0 mmol/l), as measured with CGM
- frequency of hypoglycemias
Lotgenberg, S.J. et al.: EASD
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
108UC201001158EE
Study group: • 24 patients with type 1 diabetes (13 f and 11 m)• Baseline therapy: 21 CSII, 3 MDI • Age: 43.6 + 11.8 years• Duration of diabetes: 22.6 + 10.6 years• Baseline HbA1c: 8.6 + 1.1 %
• Baseline for inclusion criteria:- 20 patients with HbA1c >7.5%
- 14 patients with > 5 hypoglycemic events per week
Lotgenberg, S.J. et al.: EASD
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
109UC201001158EE
Findings:
HbA1c (%) at different points for both groups
Lotgenberg, S.J. et al.: EASD
start IP, following CSII
start CSII, following IP
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
110UC201001158EE
Findings:
HbA1c values with both therapeutic options
8,5 8,5
8,1
7,47,6
8,58,4
6
7
8
9
10
Hb
A1
c (
%)
Baseline month 0 month 3 month 6 month 0 month 3 month 6
CIPIICSII
Lotgenberg, S.J. et al.: EASD
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
111UC201001158EE
Findings:
Time spent in euglycemia (4.0–10.0 mmol/l)
41
5953
48
41
0
20
40
60
80
Sh
are
of
tim
e p
er
da
y (
%)
Baseline month 3 month 6 month 3 month 6
CIPIICSII
Lotgenberg, S.J. et al.: EASD
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
112UC201001158EE
Findings:
Frequency of hypoglycemic events
Lotgenberg, S.J. et al.: EASD
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
2,70
3,94
2,07
3,11
0
1
2
3
4
5
Hyp
og
l. /W
och
e
CSII CIPII CSII CIPII
<4.0 mmo/l <3.5 mmol/l
Hyp
og
lyce
mic
eve
nts
(p
er w
eek)
113UC201001158EE
Conclusion:
CIPII improved glycemic control without increasing the incidence of hypoglycemic events (trend toward decrease) or increasing the amount of time spent in euglycemia. CIPII will therefore be of value for selected subjects with type 1 diabetes who do not attain acceptable levels of glycemic control on MDI or CSII.
Lotgenberg, S.J. et al.: EASD
Comparison of subcutaneous and intraperitoneal insulin infusion in patients with type 1 diabetes
114UC201001158EE
Aim of study:
Investigate acceptance, safety and effectiveness of a comprehensive diabetes treatment algorithm based on recommendations using glucose values, trends and alerts from real-time continuous glucose monitoring.
Algorithm for diabetes management based on real-time continuous glucose monitoring
Deiss, D. et al.: Evaluation of a standardized algorithm for diabetes management decisions based on real-time continuous glucose monitoring in pediatric patients with CSII. Abstract 21, 1st ATTD Meeting, Prague 2008 and: Standardized treatment algorithm for diabetes management decisions based on real-time continuous glucose monitoring, 68th ADA Scientific Session 2008, San Francisco, 2006-PO, Diabetes 2008; 57 (Suppl. 1), A554
115UC201001158EE
Method and study group:• Algorithm used for four-week period• Algorithm contains following types of behavior:
hypoglycemia (daytime, bedtime and overnight), hyperglycemia and correction rules, postprandial hyperglycemia, exercise
• 20 patients with type 1 diabetes (10 female and 10 male)• Age: 11.3 (range: 2.3-17.1 years ) • Therapy: CSII with Paradigm®REAL-Time system
Algorithm for diabetes management based on real-time continuous glucose monitoring
Deiss, D. et al.: Abstract 21, 1st ATTD Meeting, Prague 2008
116UC201001158EE
Findings: Application rate of guideline rules according to baseline HbA1c
Hypoglycemiaevents
p < .001
p = 0.034n. s.
HbA1c <7.5%
HbA1c ≥7.5%
Gu
idel
ine
rule
ap
plie
d (
%)
100
80
60
40
20
0
64%
37%
89%
78%
94%92%
Hyperglycemiatrend events
Normoglycemiatrend events
Algorithm for diabetes management based on real-time continuous glucose monitoring
Deiss, D. et al.: Abstract 21, 1st ATTD Meeting, Prague 2008
117UC201001158EE
Findings: Effect of RT algorithm on blood glucose
Event category Rules applied/ not appl.
(number)
Success rate
(percent)
Hypo event 116 115 68.5* 62.5
Hypo trend 45 58 79.1* 66.7
Hypo sport 17 23 64.7* 60.9
Hyper trend 159 28 52.6 46.2
Normo trend 53 4 81.1 50.0
Total 390 228 64.8 61.3
*Success rate more pronounced in patients with HbA1c <7.5%
Algorithm for diabetes management based on real-time continuous glucose monitoring
Deiss, D. et al.: Abstract 21, 1st ATTD Meeting, Prague 2008
118UC201001158EE
Findings: Change in HbA1c during study (using algorithm) and at follow-up (without algorithm)
N = 20
Follow-up
Studyend
Studybegin
HbA
1c (
%)
11.0
10.0
9.0
8.0
7.0
6.0
5.020 19
p =.024 p <.001
Study begin 7.6%
End of study 7.3%
Follow-up 7.9%at 3 months
MeanHbA1c
Algorithm for diabetes management based on real-time continuous glucose monitoring
Deiss, D. et al.: Abstract 21, 1st ATTD Meeting, Prague 2008
119UC201001158EE
Findings: End-of-study questionnaire ratings on guideline use and efficacy
Algorithm for diabetes management based on real-time continuous glucose monitoring
Deiss, D. et al.: Abstract 21, 1st ATTD Meeting, Prague 2008
54321
For bolus
After alarm
At arrow-up
At arrow-down
During sport
Never used
54321
Frequently Ineffective Effective
Guidelines used Efficacy
120UC201001158EE
Algorithm for diabetes management based on real-time continuous glucose monitoring
Conclusions:
The RT guidelines are a safe and effective tool that patients can use to process new information on glucose trends obtained from RT-CGM. Using the guidelines may increase glycemic stability.
Deiss, D. et al.: Abstract 21, 1st ATTD Meeting, Prague 2008