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  1. 1. Why We Pump Henry Anhalt, DO, CDE Director, Pediatric Endocrinology and Diabetes Saint Barnabas Medical Center Livingston, NJ
  2. 2. Pump Gasoline?
  3. 3. Pump Iron?
  4. 4. Pump Breast Milk?
  5. 5. THE PANCREAS THROUGHOUT HISTORY <ul><li>1550 BCE-Papyrus describes polyuria and its treatment </li></ul><ul><li>4 th century BCE-Ayur Veda of Susruta (India) described sugarcream urine which attracted ants. </li></ul><ul><li>7 th century CE-Chinese physician Chen Chuan recorded sweet urine in diabetes </li></ul><ul><li>1869-Langerhans describes islets </li></ul><ul><li>1909-the name insuline is suggested by Jean de Meyer (Brussels) </li></ul><ul><li>1921-Banting and Best-report discovering Insulin used in 1922 </li></ul>
  6. 6. BANTING-1891-1941 & BEST-1899-1978 Orthopod who became a physiologist and died in air crash in Newfoundland while on wartime mission Together they isolated insulin and Banting won the Nobel Prize in 1923 knighted in 1934
  7. 7. First commercial insulin
  8. 8. Prevalence of Diabetes in the US Diagnosed Type 1 Diabetes 1.5 Million(1:400-600 children) Diagnosed Type 2 Diabetes 14 million Undiagnosed Diabetes 6 Million 1.5 million new cases of diabetes were diagnosed in people aged 20 years or older in 2005
  9. 9. Good Glycemic Control (Lower HbA 1c ) Reduces Incidence of Complications DCCT Research Group. N Engl J Med . 1993;329:977-986. Ohkubo Y et al. Diabetes Res Clin Pract . 1995;28:103-117. UKPDS 33: Lancet . 1998;352:837-853. HbA 1c Retinopathy Nephropathy Neuropathy Macrovascular disease DCCT 9  7% 63% 54% 60% 41%* Kumamoto 9  7% 69% 70% – – UKPDS 8  7% 17-21% 24-33% – 16%* * not statistically significant
  10. 10. HbA 1c and Microvascular Complications Relative Risk 15 13 11 9 7 5 3 1 HbA 1c , % 7 8 9 10 11 12 Neuropathy Nephropathy Retinopathy
  11. 11. Every 1% HbA 1c Increase Above Goal Elevates the Risk of Diabetic Complications Increase in Any Diabetes-Related Endpoint Increase in Risk of Myocardial Infarction (MI) Increase in Risk of Stroke Increase in Risk of Microvascular Complications Incidence of Diabetes- Related Complications (%) +21% +37% +12% +14% Adapted from Stratton et al. BMJ . 2000;321:405-412.
  12. 12. Physiology of Insulin and blood glucose Breakfast Lunch Dinner Basal Insulin Insulin secretion Basal blood glucose Blood glucose
  13. 13. Insulin Preparations Onset of Duration of Action Peak Action Humalog/Novalog 5 to 15 min 1 to 2 hr 4 to 6 hr Human Regular 30 to 60 min 2 to 4 hr 6 to 10 hr Human NPH 1 to 2 hr 4 to 6 hr 10 to 16 hr Human Lente 1 to 2 hr 4 to 6 hr 10 to 16 hr Human Ultralente 2 to 4 hr Unpredictable <24 hr Lantus 30minutes none 24hr
  14. 14. NPH and regular insulin - 2 injections Bkfst lunch dinner bedtime bkfst
  15. 15. Disadvantages of NPH/ Regular regimen <ul><li>No flexibility: </li></ul><ul><li>Required certain amount of calories a day </li></ul><ul><li>Skipped meal - hypoglycemia (peak of NPH) </li></ul><ul><li>Exercise - hypoglycemia (excessive glucose use) </li></ul><ul><li>At night - hypoglycemia (peak of NPH) </li></ul><ul><li>Overeating- hyperglycemia (not enough) </li></ul><ul><li>Oversleeping- hyperglycemia (skipped dose) </li></ul>
  16. 16. Results of conventional therapy <ul><li>Poor control - HbA1C 10% and higher </li></ul><ul><li>Fear of hypoglycemia - worsening of control </li></ul><ul><li>Inability to exercise - poor fitness </li></ul><ul><li>Early development of complications </li></ul><ul><li>“ OUT OF CONTROL”-Negative reinforcement </li></ul><ul><li>“ Don’t Do This, Don’t Do That” </li></ul><ul><li>Mauriac syndrome - chronic insulin deficiency - stunted growth, hepatomegaly </li></ul>
  17. 17. <ul><li>Some causes of hypoglycemia in toddlers and preschoolers: </li></ul><ul><ul><li>Unpredictable food intake and physical activity. </li></ul></ul><ul><ul><li>Imprecise administration of low doses of insulin. </li></ul></ul><ul><ul><li>Frequent viral infections. </li></ul></ul><ul><ul><li>Inability to convey the symptoms of low blood sugar. </li></ul></ul>Adapted from Litton J et al; J Pediatr 2002;141:490-495.
  18. 19. <ul><li>IN SEARCH OF THE HOLY GRAIL </li></ul>
  19. 20. Dr. Arnold Kadish of Los Angeles, California, devised the first insulin pump in the early 1960s. It was worn on the back and was roughly the size of a Marine backpack                                                                                        
  20. 22. Humalog/Novolog versus Regular <ul><li>Rapid acting insulins: Start in 10min Peak in 1-2h Gone in 3.5-4h </li></ul><ul><li>Regular insulin: Starts in 30min Peaks in 3-4h Gone in 6-8h </li></ul>
  21. 23. Benefits of rapid acting insulins <ul><li>May be given just prior to the meal or after meal in babies </li></ul><ul><li>Time of action match rise in sugar caused by most meals </li></ul><ul><li>No action left at the time of next meal - no boluses buildups </li></ul><ul><li>Less activity at bedtime - less night “low’s” and no need for bedtime snack </li></ul>
  22. 24. WHEN WE STARTED TO DABBLE-THREE SHOTS A DAY B L S HS B Lispro Insulin Effect Meals Lispro NPH NPH
  23. 25. Twice Daily vs. Three Daily Injections <ul><li>Rationale: Avoid Dawn Phenomenon and Somogyi Effect </li></ul><ul><li>872 adolescents evaluated over a 3-year period. </li></ul><ul><li>Either regimen: </li></ul><ul><ul><li>Increased insulin dose. </li></ul></ul><ul><ul><li>Deterioration of metabolic control. </li></ul></ul><ul><ul><li>Increase in BMI. </li></ul></ul><ul><ul><li>Females faired worse than males. </li></ul></ul>Adapted from Holl R et al; Eur J Pediatr . 2003 Jan; 162(1): 22-9.
  24. 26. New Long Acting Insulin (Glargine Insulin) <ul><li>Lantus is a new type of long acting insulin that has no peaks </li></ul><ul><li>Mimics physiological insulin (basal) </li></ul>
  25. 27. INSULIN TACTICS The Basal/Bolus Insulin Concept <ul><li>Basal Insulin </li></ul><ul><ul><li>Insulin requirement to suppress hepatic glucose production between meals </li></ul></ul><ul><li>Bolus Insulin (prandial) </li></ul><ul><ul><li>Insulin requirement to maintain normal glucose disposal after eating </li></ul></ul><ul><ul><li>Insulin:CHO Ratio = 500/(total starting dose) </li></ul></ul><ul><ul><li>Correction Factor = 1500/(total starting dose) </li></ul></ul><ul><ul><li>Correction factor in young children = 1800/(total starting dose) </li></ul></ul>
  26. 28. LANTUS AND NOVOLOG-”POOR MANS PUMP” B L S HS B Lispro Insulin Effect Meals Lispro lANTUS Lispro
  27. 29. Nine Preschool Patients Meticulously Cared For With MDI Switched To CSII: <ul><li>Mean A1c 9.5% reduced to 7.9%. </li></ul><ul><ul><li>Severe hypoglycemic events 0.52 per month reduced to 0.09 per month. </li></ul></ul><ul><ul><li>Increased parental confidence and independence. </li></ul></ul><ul><ul><li>All refused to relinquish pump at completion of study. </li></ul></ul>Adapted from Litton J et al; J Pediatr 2002;141:490-495 .
  28. 30. Better Control and Less Hypoglycemia in Young Children Litton J., J Pediatr 2002;141:490-495. HbA1c Hypoglycemia
  29. 31. Injections Also Fail To Achieve Glycemic Control <ul><li>Hypoglycemia: </li></ul><ul><ul><li>MDI - 5 </li></ul></ul><ul><ul><li>CSII - 2 </li></ul></ul><ul><li>DKA: </li></ul><ul><ul><li>MDI - 0 </li></ul></ul><ul><ul><li>CSII - 0 </li></ul></ul><ul><li>Preference </li></ul><ul><ul><li>MDI - 4 of 16 </li></ul></ul><ul><ul><li>CSII - 14 of 16 </li></ul></ul>Randomized, Prospective Trial of CSII vs. MDI with Glargine in Children HbA1c (%) Adapted from Doyle E Diabetes Care July 2004 Boland E et al; Diabetes 2003; 52 (Suppl. 1): 192
  30. 32. Glycemic Memory: Sustained Beneficial Effect Of Prior Intensive Therapy <ul><li>195 patients between the ages of 13 and 17 in DCCT: </li></ul><ul><ul><li>Decreased worsening of retinopathy by 74% (p < 0.001). </li></ul></ul><ul><ul><li>Decreased progression to proliferative or severe non-proliferative retinopathy by 78% (p < 0.007). </li></ul></ul>Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.
  31. 33. Glycemic Memory: Sustained Beneficial Effect Of Prior Intensive Therapy <ul><li>195 patients between the ages of 13 and 17 in DCCT: </li></ul><ul><ul><li>Relative risk of hypoglycemia < 1 among prior intensive group. </li></ul></ul><ul><ul><li>Prevalence of microalbuminuria 48% less. </li></ul></ul><ul><li>It is vital to achieve the best glycemic control early in the course in diabetes during adolescence and childhood. </li></ul>Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.
  32. 34. <ul><li>“ Less than optimal glycemic control during the early years of diabetes has a lasting detrimental effect on the development and progression of complications, even after better glycemic control is established later in the course of the disease.” </li></ul>Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.
  33. 35. From Preschool to Prom <ul><li>161 patients with type 1 diabetes: </li></ul><ul><ul><li>26 ages 1 to 6 </li></ul></ul><ul><ul><li>76 ages 7 to 11 </li></ul></ul><ul><ul><li>59 ages 12 to 18 </li></ul></ul><ul><li>98% remained on CSII </li></ul><ul><li>Reduced hypoglycemia (events/year) </li></ul><ul><ul><li>Age 1 to 6: 0.42 to 0.19 </li></ul></ul><ul><ul><li>Age 7 to 11: 0.33 to 0.22 </li></ul></ul><ul><ul><li>Age 12 to 18: 0.33 to 0.27 </li></ul></ul>Mean HbA1c levels Adapted from Ahern J et al; Pediatr Diabetes . 2002 Mar;3(1): 10-5 .
  34. 36. World youngest pumper in 1999: 5mo old
  35. 37. World youngest pumper 2003: 10 d old
  37. 40. Purpose and Method of Study <ul><li>Purpose: compare two algorithms of management for newly diagnosed kids with diabetes in our clinic. </li></ul><ul><li>Method: A study of HbA1c level and total daily insulin dose in 2 groups of patients with new onset diabetes type 1 at diagnosis, 6 months, and 12 th months after diagnosis. </li></ul>
  38. 41. Hypothesis <ul><li>Our hypothesis are: </li></ul><ul><ul><li>Patients on pump have better control of their blood glucose level </li></ul></ul><ul><ul><li>Better control allows extension of the “honey moon” period </li></ul></ul>
  39. 42. Treatment Algorithm Algorithm #2 Algorithm #1 Treatment algorithm Group 1 (number of patients = 24) Treatment algorithm Group 2 (number of patients = 11) All patients with new onset diabetes were discharged within 3-5 days. All patients with new onset diabetes were discharged within 24 hours. Patients and parents were taught within 3 to 5 days in-hospital how to manage diabetes by pediatric endocrinology team. Patients and parents were taught within first 24 hours in-hospital how to manage diabetes by pediatric endocrinology team. Patients were started on Humalog and NPH in the hospital after correction of diabetic ketoacidosis. Patients were started on Humalog and Lantus after correction of diabetic ketoacidosis and regiment was continued for the first 1-2 weeks. CSII was started within first 14 days after diagnosis. A pediatric endocrinologist was available 24 hours a day 7 days a week to support insulin dose adjustment and education over the phone for the patients and parents. A pediatric endocrinologist was available 24 hours a day 7 days a week to support insulin dose adjustment and education over the phone for the patients and parents.
  40. 43. HbA1c
  41. 46. Total daily dose
  42. 48. Conclusion: <ul><li>Intensive teaching, 24 hour support, and CSII within 2 weeks of diagnosis improved patient’s HbA1c levels and decreased total daily dosage of insulin over traditional therapy. </li></ul><ul><li>CSII was beneficial for newly diagnosed diabetes patients at the onset of disease. </li></ul>
  43. 49. Candidates for pump therapy <ul><li>Typical Criteria </li></ul><ul><li>Only motivated patients </li></ul><ul><li>only patients who showed good compliance on previous regimen </li></ul><ul><li>Adults and children > 6y old </li></ul><ul><li>My Criteria </li></ul><ul><li>Any patient who is willing to start and has abilities to learn </li></ul><ul><li>May improve compliance </li></ul><ul><li>Any age adults and children of any age (independent users 7-80 y old) </li></ul><ul><li>Particularly “non-compliant” patients </li></ul>
  46. 52. The Yale Experience <ul><li>> 200 children started on pumps over last 5 yrs </li></ul><ul><li> </li></ul><ul><li>No difference in severe hypoglycemia </li></ul><ul><li>Parents report less mild hypoglycemia </li></ul>Ahern et al., Journal of Pediatric Endocrinology and Metabolism 2000, 13(suppl 4):1220. 7.5 7.9 13-18 7.3 7.8 7-12 6.7 7.6 < 7 3 mos post pre Age (yr) HbA 1c
  47. 53. Additional Evidence From Yale Ahern, JAH, Pediatric Diabetes 2002;3:10-15. <ul><li>Decreased hypoglycemia </li></ul><ul><li>No change in BMI or TDD </li></ul><ul><li>98% remained on CSII </li></ul>
  48. 54. CSII vs. MDI With Glargine in Children Boland et al., Diabetes 2003, 52:S1, A45, 192-OR CSII (aspart) n=12 MDI (aspart/glargine) n=14 Injection therapy Randomized, Parallel-group, 16 week study Subjects at baseline Age: 8-19 yr (mean 12.7 ± 2.7) Type 1 DM > 1 yr duration Standard insulin therapy (2-3 injections/day)
  49. 55. Pump Group Achieved Better Control Overall Changes in HbA1c Levels 6.5 7 7.5 8 8.5 Baseline 4 wks 8 wks 12 wks 16 wks Pump MDI Boland, E. Diabetes 52,(Suppl 1), 2003 Abstract 192. p = .03 p=.30 (NS) p=.15 (NS) p=.001
  50. 56. More Pump Wearers Achieved HbA1c 6.9% % Patients Achieving HbA1c < 6.9% Pump Glargine Boland, E. Diabetes 52,(Suppl 1), 2003 Abstract 192. < _ 0 10 20 30 40 50
  51. 57. Sweden’s Experience <ul><li>89 children 3-21 y.o </li></ul><ul><li>Diabetes duration 6.1 years </li></ul><ul><li>30% using CSII </li></ul><ul><li>HbA 1c decreased from 9.2% to 8.4% after CSII start </li></ul><ul><li>Severe hypos </li></ul><ul><ul><li>Pump: 11.1/100 pt years </li></ul></ul><ul><ul><li>MDI: 40.3/100 pt years </li></ul></ul>. Hanas, Diabetes, 2000, 49 (Suppl 1):A133 .
  52. 58. Patient Characteristics of Successful Pediatric Pumpers <ul><li>Able to maintain follow up appointments with health care provider </li></ul><ul><li>Willing to record blood glucose values </li></ul><ul><li>Able to count carbohydrates </li></ul><ul><li>Good family/social support system </li></ul>
  53. 59. Pump therapy benefits <ul><li>Improved control - more physiological basal rates (“dawn phenomenon” match), different boluses for food, less absorption variability </li></ul><ul><li>Less hypoglycemia </li></ul><ul><li>More flexible lifestyle and possibility to exercise </li></ul><ul><li>Precise dosing - 0.1u - 0.025u increments for basal rate and boluses </li></ul><ul><li>Less injections - improved quality of life </li></ul><ul><li>Less possibility of overdose </li></ul>Adapted from Plotnick L et al; Diabetes Care 2003; 26(4):1142-1146.
  54. 60. Pump Use in Children Is Increasing <ul><li>200,000 users (adults and kids in the US). 10,000 are adults with type 2 diabetes </li></ul><ul><li>~ 20,000 children using pump therapy </li></ul><ul><ul><li>10% of all children with diabetes </li></ul></ul><ul><li>Penetration as high as 90% in some pediatric clinics (ours) </li></ul><ul><li>Increasing use in younger children (as young as 10 months) </li></ul><ul><li>Current outcomes indicate CSII is safe and effective in children </li></ul><ul><li>Increasing acceptance likely due to DCCT findings as well as the introduction of smaller, safer insulin pumps </li></ul><ul><li>There are approximately 400,000 insulin pump users worldwide </li></ul>
  55. 61. Avoiding DKA <ul><li>Give a pen with the pump </li></ul><ul><li>Instruct that any time the patient feels nauseated or has abdominal pain -- change the site </li></ul><ul><li>Blood sugar is greater than 250 mg/dl </li></ul><ul><ul><li>Take correction dose </li></ul></ul><ul><ul><li>Check for ketones </li></ul></ul><ul><ul><li>Recheck in 60 minutes </li></ul></ul><ul><ul><ul><li>If coming down, leave alone </li></ul></ul></ul><ul><ul><ul><li>If not, take a shot and change the site </li></ul></ul></ul>
  56. 62. Summary <ul><li>Pump therapy is an intensive process for pediatric patients and their families and the diabetes education team. </li></ul><ul><li>Successful pumpers are motivated and willing to maintain follow-up, carbohydrate count, and check blood glucose frequently. </li></ul><ul><li>Benefits of pump therapy for pediatric patients include: improved lifestyle, decrease in hypoglycemia, accurate dosing , ability to review history to see if doses were actually given. </li></ul>
  57. 63. Summary <ul><li>Children with diabetes should be intensively treated to avoid short and long term complications </li></ul><ul><li>Insulin pumps can provide better control and less hypoglycemia than MDI </li></ul><ul><li>With good support and a standardized process, insulin pump therapy can help to improve diabetes management in children </li></ul><ul><li>Insulin pump therapy should be the only form of therapy offered to children with diabetes </li></ul>
  58. 64. When meditating over a disease, I never think of finding a remedy for it, but rather, a means of preventing it. Louis Pasteur, 1884