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Insulin Pump Therapy in children & Adolescents
Dr. Abdulmoein Al-Agha, MBBS,DCH, FRCP(UK) Pediatric Endocrinologist
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Banting and Best
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The Miracle of Insulin Patient J.L., December 15, 1922
February 15, 1923
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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
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What’s different about children ?
Marked dawn phenomenon Unpredictable activity levels Unpredictable food habits Nocturnal hypoglycaemia Hormonal changes Growth & developmental changes 5
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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 ????
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DCCT: the price of improved diabetic control – hypoglycaemia
2 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
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The Pump Mimics the Pancreas
Meal Boluses Adjustable Basal Rate
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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)
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Insulin Pump Therapy
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first child of 5 year of age had insulin pump inserted at 2003
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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
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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
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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
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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.
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Pump Therapy Team Endocrinologist
24 – hour technical support company representative Dietician Pump therapy Nurse 24 –Hour hotline contact.
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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
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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
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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.
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Pump Therapy Reduces Incidents of Severe Hypoglycemia Severe Hypoglycemic Episodes MDI vs CSII
20 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;
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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
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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
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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
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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
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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
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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.
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Interstitial Fluid Measurement
Interstitial fluid glucose (G2) is almost always comparable with blood glucose (G1) 29
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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
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Thanks شكرا" لكم 32
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