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Why We Pump

Why We Pump. Henry Anhalt, DO, CDE Director, Pediatric Endocrinology and Diabetes Saint Barnabas Medical Center Livingston, NJ. `In the past we had a light that flickered, in the present, a light that flames, and in the future we will have a light that shines over all the land and the sea’

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Why We Pump

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  1. Why We Pump Henry Anhalt, DO, CDE Director, Pediatric Endocrinology and Diabetes Saint Barnabas Medical Center Livingston, NJ

  2. `In the past we had a light that flickered, in the present, a light that flames, and in the future we will have a light that shines over all the land and the sea’ Winston Churchill

  3. Pump Gasoline?

  4. Pump Iron?

  5. Pump Breast Milk?

  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. First commercial insulin

  8. Prevalence of Diabetes in the US Diagnosed Type 1 Diabetes1.5 Million(1:400-600 children) Diagnosed Type 2 Diabetes14 million Undiagnosed Diabetes6 Million 1.5 million new cases of diabetes were diagnosed in people aged 20 years or older in 2005

  9. Good Glycemic Control (Lower HbA1c) Reduces Incidence of Complications DCCT 9  7% 63% 54% 60% 41%* Kumamoto 9  7% 69% 70% – – UKPDS 8  7% 17-21% 24-33% – 16%* HbA1c Retinopathy Nephropathy Neuropathy Macrovascular disease * not statistically significant 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.

  10. HbA1c and Microvascular Complications Retinopathy 15 13 11 9 7 5 3 1 Nephropathy Relative Risk Neuropathy 7 8 9 10 11 12 HbA1c, % 10

  11. Every 1% HbA1c Increase Above Goal Elevates the Risk of Diabetic Complications +37% Incidence of Diabetes-Related Complications (%) +21% +14% +12% Increase in Any Diabetes-Related Endpoint Increase in Risk of Myocardial Infarction (MI) Increase in Risk of Stroke Increase in Risk of Microvascular Complications Adapted from Stratton et al. BMJ. 2000;321:405-412.

  12. Physiology of Insulin and blood glucose Insulin secretion Basal Insulin Breakfast Lunch Dinner Blood glucose Basal blood glucose

  13. Insulin Preparations Onset ofDuration of ActionPeak Action Humalog/Novalog5 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. NPH and regular insulin - 2 injections Bkfst lunch dinner bedtime bkfst

  15. Disadvantages of NPH/ Regular regimen • No flexibility: • Required certain amount of calories a day • Skipped meal - hypoglycemia (peak of NPH) • Exercise - hypoglycemia (excessive glucose use) • At night - hypoglycemia (peak of NPH) • Overeating- hyperglycemia (not enough) • Oversleeping- hyperglycemia(skipped dose)

  16. Results of conventional therapy • Poor control - HbA1C 10% and higher • Fear of hypoglycemia - worsening of control • Inability to exercise - poor fitness • Early development of complications • “OUT OF CONTROL”-Negative reinforcement • “Don’t Do This, Don’t Do That” • Mauriac syndrome - chronic insulin deficiency - stunted growth, hepatomegaly

  17. Some causes of hypoglycemia in toddlers and preschoolers: • Unpredictable food intake and physical activity. • Imprecise administration of low doses of insulin. • Frequent viral infections. • Inability to convey the symptoms of low blood sugar. Adapted from Litton J et al; J Pediatr 2002;141:490-495.

  18. IN SEARCH OF THE HOLY GRAIL

  19. 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. Humalog/Novolog versus Regular • Rapid acting insulins: Start in 10min Peak in 1-2h Gone in 3.5-4h • Regular insulin: Starts in 30min Peaks in 3-4h Gone in 6-8h

  21. Benefits of rapid acting insulins • May be given just prior to the meal or after meal in babies • Time of action match rise in sugar caused by most meals • No action left at the time of next meal - no boluses buildups • Less activity at bedtime - less night “low’s” and no need for bedtime snack

  22. New Long Acting Insulin (Glargine Insulin) • Lantus is a new type of long acting insulin that has no peaks • Mimics physiological insulin (basal)

  23. INSULIN TACTICSThe Basal/Bolus Insulin Concept • Basal Insulin • Insulin requirement to suppress hepatic glucose production between meals • Bolus Insulin (prandial) • Insulin requirement to maintain normal glucose disposal after eating • Insulin:CHO Ratio = 500/(total starting dose) • Correction Factor = 1500/(total starting dose) • Correction factor in young children = 1800/(total starting dose)

  24. LANTUS AND NOVOLOG-”POOR MANS PUMP” Lispro Lispro Lispro Insulin Effect lANTUS B L S HS B Meals

  25. Nine Preschool Patients Meticulously Cared For With MDI Switched To CSII: Mean A1c 9.5% reduced to 7.9%. • Severe hypoglycemic events 0.52 per month reduced to 0.09 per month. • Increased parental confidence and independence. • All refused to relinquish pump at completion of study. Adapted from Litton J et al; J Pediatr 2002;141:490-495.

  26. Better Control and Less Hypoglycemia in Young Children HbA1c Hypoglycemia Litton J., J Pediatr 2002;141:490-495.

  27. Glycemic Memory: Sustained Beneficial Effect Of Prior Intensive Therapy 195 patients between the ages of 13 and 17 in DCCT: • Decreased worsening of retinopathy by 74% (p < 0.001). • Decreased progression to proliferative or severe non-proliferative retinopathy by 78% (p < 0.007). Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.

  28. Glycemic Memory: Sustained Beneficial Effect Of Prior Intensive Therapy 195 patients between the ages of 13 and 17 in DCCT: • Relative risk of hypoglycemia < 1 among prior intensive group. • Prevalence of microalbuminuria 48% less. It is vital to achieve the best glycemic control early in the course in diabetes during adolescence and childhood. Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.

  29. “ 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.” Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.

  30. From Preschool to Prom 161 patients with type 1 diabetes: • 26 ages 1 to 6 • 76 ages 7 to 11 • 59 ages 12 to 18 98% remained on CSII Reduced hypoglycemia (events/year) • Age 1 to 6: 0.42 to 0.19 • Age 7 to 11: 0.33 to 0.22 • Age 12 to 18: 0.33 to 0.27 Mean HbA1c levels Adapted from Ahern J et al; Pediatr Diabetes. 2002 Mar;3(1): 10-5.

  31. World youngest pumper in 1999: 5mo old

  32. World youngest pumper 2003: 10 d old

  33. I WAS A NON-BELEIVER • TOO HARD/TIME CONSUMING • I WAS UNINFORMED ON HOW TO USE THEM • NOT FOR THE VERY YOUNG OR THE UNMOTIVATED • ONLY AFTER HONEYMOON • YOU HAVE TO TEST FOR ME TO PUT YOU ON PUMP • YOU WILL SUFFER PSYCHOLOGICALLY

  34. Introduction • Test the feasibility and efficacy of insulin pump therapy initiated within the first month of diagnosis • N=28 consecutive. mean age 12.1+ 6.2 years • Range of start 1-30 days • None discontinued after up to three year follow-up • 2 sites Cornell Medical Center and Maimonides Medical Center

  35. Hypothesis • Our hypothesis are: • Patients on pump have better control of their blood glucose level • Better control allows extension of the “honey moon” period

  36. Rationale and Hypothesis • Earlier aggressive glucose control leads to lower incidence of long-term complications • Insulin pump therapy resembles physiology more closely than multiple daily injections • Lower incidence of occult and overt serious and moderate hypoglycemia • Would there be benefit to introducing pump therapy earlier rather than waiting until further insulinopenia sets in?

  37. Demographics Range 26 months to 32 years Average time to pump start 16 days+ 11 days 3 went straight to pump and 2 started within one week

  38. Mean HbA1c Levels Pre and Post Initiation

  39. HbA1c

  40. Insulin Burden (U/kg)

  41. C Peptide AUC-In response to MMTT (Boost)

  42. Other Significant Findings • BMI-No significant gains or losses in BMI SD over study time • All patients were “self-sufficient” within 3 months

  43. Conclusions • Starting patients on insulin pump therapy is a viable option at or soon after diagnosis • Further studies need to be performed to see if quality of life and long term complications are affected • Despite the labor intensivity of this approach the benefits were clear and patients opted to remain on pump therapy after treatment • Apparent prolongation of the honeymoon

  44. Typical Criteria Only motivated patients only patients who showed good compliance on previous regimen Adults and children > 6y old My Criteria Any patient who is willing to start and has abilities to learn May improve compliance Any age adults and children of any age (independent users 7-80 y old) Particularly “non-compliant” patients Candidates for pump therapy

  45. ADVERSE EVENTS

  46. PSYCHOSOCIAL OUTCOMES

  47. The Yale Experience • > 200 children started on pumps over last 5 yrs • No difference in severe hypoglycemia • Parents report less mild hypoglycemia Ahern et al., Journal of Pediatric Endocrinology and Metabolism 2000, 13(suppl 4):1220.

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