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

Transcription

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

2 Insulin The most powerful agent we have to control glucose

3 Banting and Best

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

5 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

6 Ideal Basal/Bolus Insulin Absorption Pattern Breakfast Lunch Dinner Plasma insulin 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Time 8:00

7 Intensive Insulin Therapy Goals Maintain normal or near to normal blood glucose Avoid short-term crisis Prevent and postpone long-term complications

8 What s Different about children? Marked dawn phenomenon Unpredictable activity levels Nocturnal hypoglycaemia Hormonal changes Growth & developmental changes

9 A1C Goals for Children young age group < 6 yr = < % 6 11 yr = <7.5% yr = <7.0% How to accomplish????

10 DCCT: the price of improved diabetic control hypoglycaemia 12 Rate pf progression of retinopathy (per 100 patient years) Rate of severe hypoglycemia (per 100 patient years) severe hypoglycaemia risk of retinopathy HbA 1c (%) Adapted from: N Engl J Med 1993;329:977 86

11 Insulin Pump Therapy

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

13 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. The consensus that insulin replacement should be more physiologic grew during the 70s,first by employing continuous intravenous insulin delivery, and then by the more practical means of continuous subcutaneous insulin infusion (CSII)

14 In 1978, Keen and Pickup from Guy's Hospital, London first reported the successful use of portable pumps for CSII Followed in 1979 by Tamborlane and Felig of Yale These early studies demonstrated that CSII, when used with self-monitoring of blood glucose, could feasibly achieve near normal glycaemic control These early insulin pumps - though a vast improvement on the Kadish device - were bulky, being the size of a house brick and weighing up to 400grams

15 Technical issues such as syringe and tubing blockages, overdelivery of insulin and needle dislodgment were widely reported These problems led to clinical complications including, hypoglycemia, diabetic ketoacidosis (DKA) and needle site infection, resulting in only limited acceptance throughout the 1980s by both clinicians and patients Re- Started again late 1990 s, with major advances in the field of medical device technology, which allowed dramatic reductions in the size of the pump, brought enhanced safety & allowed greater ease of use for patients Currently, most pumps are about the size of a hand-held pager and have features such as programmable memory, multiple basal rates, several bolus options, safety lockout features, & remote control

16 250,000 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

17 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

18 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

19 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.

20 Pump Therapy Team 1. Endocrinologist hour technical support company representative 3. Dietician 4. Pump therapy Nurse Hour hotline contact.

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

22 Basal Insulin Flexibility Multiple basal rates to match diurnal variations Most type 1 patients use 3-5 basal rates. Customized basal rate profiles for different occasions Up to 3 basal rate patterns: Weekend vs. Weekday, Ramadan Temporary Basal rate feature: Exercise, Illness, etc. Medtronic Minimed, Inc. 508 insulin pump. Accessed February 8, 2008.

23 The Bolus Wizard Calculator Individually customized with: Blood glucose targets Carbohydrate ratios Insulin-sensitivity factors Active Insulin Time Simplifies diabetes management Calculates estimated bolus for the patient Tracks active insulin Medtronic Bolus Wizard Minimed, is a registered Inc. Bolus trademark Wizard Calculator. of Medtronic Diabetes. Accessed February 7, 2008.

24 Benefits of Insulin Pump Therapy 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 β-cell function Hb A 1C 1.Wainstein J, et al. Diabet Med. 2005;22(8): Labrousse-Lhermine F, et al. Diabetes Metab. 2007;33(4):

25 Benefits of Insulin Pump Therapy Less frequent and/or severe hypoglycemia More predictable absorption than with longer acting insulin One injection site Decreases variable absorption Programmable delivery - Fewer injections, convenient Improve BG control and A1C Flexible eating schedule Matching insulin dose precisely to need Corrects Dawn phenomenon Reduce insulin quickly for exercise

26 Outcomes of Pump Therapy Kauffman et al.diabetes Metabolism and Reviews, months data 130 subjects PRE POST P Value HbA1C % 8.4 +/ / Hypoglycemia Events/pt/year DKA Events/pt/year

27 1. Bruttomesso D, et al. Diabet Med. 2002;19(8): Bell DSH, et al. Endocr Pract. 2000;6(5): Rudolph DS, et al. Endocr Pract. 2002;8(6): Chantelau E, et al. Diabetologia. 1989;32(7): Boland EA, et al. Diabetes Care. 1999;22(11): Maniatis AK, et al. Pediatrics. 2001;107(2): Litton J, et al. J Pediatr. 2002;141(4): Continuous Subcutaneous Insulin Infusion (CSII) Improves Control Compared with MDI, insulin pumps are more effective at reducing HbA 1C 9.5 MDI 9.0 CSII 8.5 HbA 1C, % Bruttomesso 1 Bell 2 Rudolph 3 Chantelau 4 Boland 5 Maniatis 6 Litton 7 (n=138) (n=58) (n=107) (n=116) (n=25) (n=56) (n= 9) Duration 89 months 36 months 36 months 54 months 12 months 12 months 13 months

28 CSII Reduces HbA 1c HbA 1c Pre-pump Post-pump Bell Rudolph Chanteleau Bode Boland Chase n = 58 n = 107 n = 116 n = 50 n = 25 n = 56 Mean dur. = 36Mean dur. = 36 Mean dur. = 54 Mean dur. = 42 Mean dur. = 12 Mean dur. = 12 Adults Adolescents Chantelau E, et al. Diabetologia. 1989;32: ; Bode BW, et al. Diabetes Care. 1996;19: ; Boland EA, et al. Diabetes Care. 1999;22: ; Bell DSH, et al. Endocrine Practice. 2000;6: ; Chase HP, et al. Pediatrics. 2001;107:

29 Pump Therapy Reduces Incidents of Severe Hypoglycemia Severe Hypoglycemic Episodes MDI vs CSII 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;

30 Decreased Risk of Severe Hypoglycemia Severe Hypoglycemia in Children by Type of Therapy Rate/100 patient yrs 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

31 CGMS shows: Less Variability With Pump Therapy Insulin pump Multiple daily injections

32 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

33 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

34 Improved Health Status with Insulin Pump Therapy Improved 82% Worse 2% N=886 Self-Reported Data No Change 16% Association for Insulin Pump Therapy, Diabetes 1991:40:#1807

35 Continuous Subcutaneous Insulin Infusion Continued 97% (CSII) N = 165 Average Duration = 3.6 years Average Discontinuation <1%/yr Bode BW, et al. Diabetes. 1998;47(suppl 1):392. Discontinued 3%

36 Insulin Pump Disadvantages Expense Requires SBGM at least 4 times a day Must be worn 24 hours per day Should not be removed for > ~45 min Increased risk of DKA Must learn to adjust insulin for food & exercise accurately

37 If A1C Not to Goal Must look at: SMBG frequency and recording Diet practiced Do they know what they are eating? Do they bolus for all food and snacks? Infusion site areas Are they in areas of lipohypertrophy? Other factors: Fear of low BG Overtreatment of low BG

38 If A1C Not to Goal and No Reason Identified Place on a continuous glucose monitoring system (CGMS) to determine the cause

39 CGM Devices Dexcom Medtronic Real Time Abbott Navigator

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

41 Logbook Diary Limitations: The Traditional Approach Problems faced with logbook approach 1,2 : Noncompliance: inconsistent record-keeping Incorrect transcription of glucose Missing data: I forgot at home or I left it in the car Adding data: falsification of information Illegibility of diary 1. Gonder-Frederick LA, et al. Diabetes Care. 1988;11(7): Ziegler O, et al. Diabetes Care. 1990;13(2):

42 FDA Approved Real-Time Continuous Glucose Monitoring System

43 Summary Insulin pump therapy offers improvement in glycemic control with less major hypoglycemia and greater flexibility in lifestyle Insulin pump therapy should be considered in all DM 1 patients and DM 2 patients failing conventional insulin therapy (basal insulin)

44 Summary Good control of blood glucose is important Pump therapy has shown in many patients to improve control and life style Pump therapy is used by over 250,000 people worldwide It is safe, but until CSII is a closed-looped system, 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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