1. Insulin Pump Therapy in children & Adolescents
Dr. Abdulmoein Al-Agha, MBBS,DCH, FRCP(UK)
Pediatric Endocrinologist

2. Banting and Best

3. The Miracle of Insulin Patient J.L., December 15, 1922
February 15, 1923

4. Goals of diabetes care Near normal glycemia A1c goals for children
Avoid short-term crisis
Hypoglycemia
Hyperglycemia
DKA
Minimize long term complications
Improve quality of life

5. What’s different about children ?
Marked dawn phenomenon
Unpredictable activity levels
Unpredictable food habits
Nocturnal hypoglycaemia
Hormonal changes
Growth & developmental changes 5

6. young age group < 6 yr = < 8 – 8.5 %
A1C Goals for Children
young age group < 6 yr = < 8 – 8.5 %
6 – 11 yr = <7.5%
12 – 20 yr = <7.0%
How to accomplish ????

7. DCCT: the price of improved diabetic control – hypoglycaemia2 4 6 8 10 12
5.5
6.5 7
7.5
8.5 9
9.5
10.5
120 60
HbA1c (%)
risk of
retinopathy
severe hypoglycaemia
Rate pf progression of retinopathy (per 100 patient years)
Rate of severe hypoglycemia (per 100 patient years)
During DCCT, the risk of retinopathy increased with worsening glycaemic control (as measured by HbA1c). Conversely, as glycaemic control improved, the risk of severe hypoglycaemia increased. Consequently, improved glycaemic control reduced the risk of retinopathy but was accompanied by a three-fold increased risk of hypoglycaemia in the intensively-treated group.
Adapted from: N Engl J Med 1993;329:977–86

8. The Pump Mimics the Pancreas
Meal
Boluses
Adjustable Basal Rate

9. EVOLUTION OF INSULIN PUMP THERAPY
The idea of continuous insulin delivery first emerged in the early 1960s when Dr Arnold Kadish from Los Angeles fashioned a device that would permit such insulin delivery
This device was the size of an army backpack making it impractical for everyday use
First pump employed continuous intravenous insulin delivery, and then by the more practical means of continuous subcutaneous insulin infusion (CSII)

10. Insulin Pump Therapy

13. first child of 5 year of age had insulin pump inserted at 2003

14. UK has variable access and provision of CSII therapy
250,000 people in the UK have type 1 diabetes
UK has variable access and provision of CSII therapy
Current UK usage of insulin pumps is low
(NICE 2008)
Estimated insulin pump usage in different countries (J Pickup)
Graph reproduced courtesy of Diabetes UK 14

15. Current CSII Candidate Selection
Patient Requirements
Motivated to take insulin
Educated and reliable parents
Willing to monitor and record BG
Willing to quantify food intake “Carb counting”
Willing to follow-up
Patient must be willing to monitor and record blood glucose levels.
generally memory meters are not adequate
patients who write down blood glucose values do better
relying on memory and downloading data from the meter is not enough
Patient should be motivated to take insulin.
those who don’t want insulin won’t do well on the pump
there may be larger issues such as inability to accept the disease
Patient must be willing to quantify and record food intake.
many find carbohydrate counting a simple approach
no need to become expert carbohydrate counters – only need to be able to make simple calculations about how much insulin they need to cover for various foods
Patient must be willing to adhere to follow up.
hypertension, hyperlipidemia, neuropathies, and other complications and concomitant conditions still need to be followed
understand the need to have the pump adjusted in terms of their basal and bolus rates—for example, to compensate for declining insulin sensitivity as they age
For a patient with an interest in extending life, being on a pump can improve their sense of self-assuredness and self-respect.
Anxiety reduction with pump usage is found both in pediatric and adult type 1 diabetes population as well as their family members.
(Boland EA, et al. Diabetes Care : ; Shapiro J, Wigg D, et al. Diabetes Care 1984;7: ) 15

16. Consensus Statement on Pump Use in Peds- Patient Selection
Recurrent severe hypoglycemia
Wide fluctuations in bg levels regardless of A1c
Suboptimal diabetes control
Micro/macro vascular complications
Good control but regimen compromises lifestyle
Infants and neonates

17. Adolescents with eating disorders
Children and adolescents with pronounced dawn phenomenon
Pregnant adolescents
Ketosis-prone individuals*
Competitive athletes
Children with needle phobia**
Battelino,P.M., Rodriguez,H.D., Kauffman, F. Use of insulin pump therapy in the pediatric age-group: consensus statement from the European Society for Paediatric Endocrinology, the Lawson Wilkins Society and the International Society for Pediatric and Adolescent Diabetes, endorsed by the American Diabetes Association and the European Association for the study of Diabetes Care Diabetes Care 2007:30:,
*Blackett PR: Insulin Pump Treatment for Recurrent Ketoacidosis in Adolescence; Diabetes Care;1995;18: **Maniatis AK et al, Pediatric Diabetes 2001 June;2(2):51-57.

18. Pump Therapy Team Endocrinologist
24 – hour technical support company representative
Dietician
Pump therapy Nurse
24 –Hour hotline contact.

19. Pump Therapy Meal boluses Basal rate
Continuous flow of insulin, took the place of NPH or glargine insulin
Meal boluses
Insulin needed pre-meal
Pre-meal BG
Carbohydrates in meal
Correction bolus for high BG 6 5 4
Meal bolus
Units 3 2 1
Basal rate
12 am
12 pm
12 am
Time of day

20. Benefits of Insulin Pump Therapy
Wainstein: 1041-A
Improved glycemic control
Less frequent / severe hypoglycemia
Enhanced quality of life
Improved patient satisfaction
Ease of management
Reduced glucose toxicity, which may also result in improved -cell function
Wainstein: 1044-A
HbA1C
Wainstein: 1044-A
Labrousse-Lhermaine: 253-A
Wainstein: 1042-A
Wainstein: 1042-A
Benefits of Insulin Pump Therapy for Type 2 Patients
Key Point:
Infusion of insulin with an insulin pump has multiple benefits
There are multiple benefits of continuous subcutaneous insulin infusion (CSII) or administration of insulin using an insulin pump. These benefits include:
Improved glycemic control1
Reduced glucose toxicity1
Preservation of -cells1
Enhanced quality of life2
Improved patients satisfaction1
Ease of management1
Why is insulin pump therapy more effective?
Because it works more like a healthy pancreas1
More predictable insulin absorption3
More flexible basal rates2
More accurate bolus dosing2
References:
1. Wainstein J, Metzger M, Boaz M, et al. Insulin pump therapy vs. multiple daily injections in obese type 2 diabetic patients. Diabet Med. 2005;22(8):
2. Labrousse-Lhermine F, Cazals L, Ruidavets J-B, Hanaire H. Long-term treatment combining continuous subcutaneous insulin infusion with oral hypoglycaemic agents is effective in type 2 diabetes. Diabetes Metab. 2007;33(4):
3. Lauritzen T, Pramming S, Deckert T, Binder C. Pharmacokinetics of continuous subcutaneous insulin infusion. Diabetologia. 1983;24(5):
Wainstein: 1041-A
Wainstein: 1044-A
Wainstein: 1044-A
Labrousse-Lhermaine: 253-A
Wainstein: 1042-A
Wainstein: 1042-A
Wainstein J, et al. Diabet Med. 2005;22(8):
Labrousse-Lhermine F, et al. Diabetes Metab. 2007;33(4):
Wainstein: 1044-AC
Lauritzen 1983: 329-A,B
Labrousse-Lhermaine: 254-A,B

21. CSII Reduces HbA1c Pre-pump Post-pump HbA1c Adults Adolescents
10.0
Pre-pump Post-pump
9.5
.09
8.5
8.0
HbA1c
7.5
7.0
6.5
6.0
5.5
5.0
Bell Rudolph Chanteleau Bode Boland Chase
n = 58 n = 107 n = 116 n = 50 n = 25 n = 56
Mean dur. = 36
Mean dur. = 36
Mean dur. = 54
Mean dur. = 42
Mean dur. = 12
Mean dur. = 12
Adults
Adolescents
Chantelau E, et al. Diabetologia. 1989;32:421–426; Bode BW, et al. Diabetes Care. 1996;19:324–327;
Boland EA, et al. Diabetes Care. 1999;22:1779–1784; Bell DSH, et al. Endocrine Practice. 2000;6:357–360;
Chase HP, et al. Pediatrics. 2001;107:351–356.

22. Pump Therapy Reduces Incidents of Severe Hypoglycemia Severe Hypoglycemic Episodes MDI vs CSII20 40 60 80
100
120
140
Events per Hundred
patient years
MDI
Pump
Bode
Boland
Rudolph
n=55
n=25
n=107
Adapted from Bode,BW et al., Diabettes Care 1996, 19: Boland, EA et al., Diabetes Care 1999, 22: Rudolph JW, Hirsch IB. Assessment of Therapy with ContinuousSubcutaneous Insulin Infusion in an Academic Diabetes Clinic. Endocrine Practice 2002: 8;

23. Decreased Risk of Severe Hypoglycemia
Severe Hypoglycemia in Children by Type of Therapy 18 16 14 12 10
Rate/100 patient yrs 8
Hypoglycemia In Children With Type 1 Diabetes: Current Issues And Controversies
T.W. Jones, E.A. Davis
Western Australia Institute of Child Health Research, Perth, Australia
Purpose: Review article examining the problem of hypoglycemia in children and adolescents with diabetes
Selected Highlights:
Hypoglycemia is an alarmingly common complication of insulin therapy, particularly in the young.
DCCT: 3 fold increased risk of severe hypo with intensive treatment
CGMS: has shown widespread occurrence of asymptomatic hypoglycemia
- Mostly nocturnal and present in up to 50% of young children
For children and adolescents with diabetes, the risk of hypoglycemia may:
Prevent optimal glycemic control
Add significantly to the psychosocial burden of the disease.
A number of reports have estimated rates of hypoglycemic comas and convulsions to be approximately 20 events per 100 patient years in children on current conventional therapy.
Consequences of hypoglycemia
Cognitive impairment
Academic difficulties -- difficulties with memory, visuo-spatial skills, and attention
Children < 6 yrs at greatest risk when brain is developing
Neuropsychological complications within 2 years of diagnosis of diabetes
Some studies have found no evidence of a relationship between intellectual development/hypoglycemia
Several reports in children have shown that insulin pump therapy is associated with fewer hypoglycemic events in addition to improved glycemic control (Maniatis, Lindeschova, Ludvigsson, Ahern).
Rates of severe hypoglycemia are shown for the first 100 children and adolescents treated with CSII in our clinic (ages yrs) -- Figure 3.
This may be because CSII therapy allows for lower and more adjustable basal insulin delivery than intermittent injection therapy offers, especially at night when hypoglycemia is particularly common.
CGMS use has brought into focus the widespread occurrence of asymptomatic hypoglycemia.
Asymptomatic hypoglycemia has long been recognized, particularly at night, when the combination of excessive insulin action and suppressed counterregulatory hormone responses put children at special risk of hypoglycemia.
Continued prospective monitoring of hypoglycemia rates and consequences has become an essential component of diabetes management.
It is anticipated that therapeutic and technological advances will reduce the impact of hypoglycemia and allow for the achievement of improved glycemic control without the expected increased risk of severe hypoglycemia.
Jones TW, Davis EA. Hypoglycemia in Children with Type 1 Diabetes: Current Issues and Controversies. Pediatric Diabetes 2003; 4: 6 4 2
2 Inj (n=244)
MDI (n=122)
CSII (n=100)
Adapted from Jones TW, Davis EA. Hypoglycemia in Children with Type 1 Diabetes: Current Issues and Controversies. Pediatric Diabetes 2003; 4: 143 23

24. CGMS shows: Less Variability With Pump Therapy
Insulin pump
Multiple daily injections
Transition to next slide: Now that we we’ve seen how Pump Therapy, along with Continuous Glucose Monitoring, provides optimum glucose control, here are some examples of how Pump Therapy may apply to your patients. 24

25. Normalization of Lifestyle
Liberalization of diet — timing & amount
Increased control with exercise
Able to work shifts & through lunch
Less hassle with travel — time zones
Weight control
Less anxiety in trying to keep on schedule

26. Improved Quality of Life
Better control makes patients feel better
No more schedules to follow
Patients can eat what they want and when they want
Insulin delivery can be adjusted to daily needs

27. Insulin Pump Disadvantages
Expense
Requires SBGM at least 4 times a day
Must be worn 24 hours per day
Should not be removed for > ~60 min
Increased risk of DKA
Must learn to adjust insulin for food & exercise accurately

28. Sensor
A tiny, sterile, flexible electrode inserted just under the skin
The sensor measures glucose values every 10th second, up to 5-7 days
A tiny electrode applied just under the skin and the sensor measures glucose values every 10th second
One sensor can be used up to 3 days.

29. Interstitial Fluid Measurement
Interstitial fluid glucose (G2) is almost always comparable with blood glucose (G1) 29

31. Summary
Insulin pump therapy offers improvement in glycaemic control with less major hypoglycemia & greater flexibility in lifestyle
Pump therapy has shown in many patients to improve control and life style
Pump therapy is used by over 250,000 people worldwide
Pump therapy must only be considered for children who are cared for by a parent or another adult willing and able to learn how to manage all aspects of the pump

32. Thanks شكرا" لكم 32