1. Insulin Pump Therapy Case Studies Sandra Weber, MD and Bruce W. Bode, MD

2. Candidates for Flexible (Intensive or Targeted) Insulin Therapy l All Type 1 Diabetes l Type 2 Diabetes failing OHA or basal insulin l Diabetes in Pregnancy not at goal

3. Metabolic Advantages with CSII l Improved glycemic control l Better pharmacokinetic delivery of insulin –Less hypoglycemia –Less insulin required l Improved quality of life

4. Case 1: DM 1 not at goal A1C l 35 year old female physician presents with Type 1 Diabetes since age 7 l Control suboptimal (A1C 8.7%) on MDI with Regular AC and NPH HS. l SMBG 5/day with CHO counting l Complications: mild retinopathy and neuropathy, and hypoglycemia induced migraines

5. Case 1: DM 1 not at goal A1C l Recommend CSII but refuses; Does not want to be attached to something l Ask her to record, monitor 6 to 7 times per day, fax readings, and try lispro l She complies with minimal change in A1C falling to 8.4% at 3 months and 7.7% at 6 months l Still refuses CSII l Recommend a sensor (CGMS)

6. Case 1: DM 1 not at goal A1C l CGMS confirms a dawn rise l Try giving NPH later but no help; Try lente and ultralente but no help; Glargine only available in Germany l Patient gets married and desires children l Attempt to get Glargine from Germany but my contacts say no one uses glargine in pregnancy. Put her on a pump

7. Total Daily Dose = 0.23 x Wgt. In lbs. Basal Dose = 0.47 x Total Daily Dose CIR = (2.8 x Wgt in lbs) / TDD (Anywhere from 5 to 25 g CHO is covered by 1 unit of insulin) Correction Factor = 1700 / TDD Target = 100 mg/dl Pump Formulas Davidson et al: Diabetes Tech & Therap. April 2003

8. Case 1: New to a Pump l Wgt 135 #; Ht 68”; on 36 units total daily dose l What is the starting dose on pump? l Two methods: 1) TDD x 75% = 27 units 2) Wgt in lbs. x 0.23 = 31 units l Since hx of lows and no rush, select lower number

9. Case 1: New to a Pump l What is the basal rate? l TDD on pump x 48% 27 units x 48% = 13 units = 0.5 units/hour l What is the bolus dose or CIR? 27 units X 52% = 14 units or ~4.5 units with each meal or CIR = 2.8 x Wt / TDD = 2.8 x 135 / 27 = 14 meaning 1 unit will cover 14 gm of CHO

10. Case 1: New to a Pump l What is the correction factor? l CF = 1700 / TDD = 1700 / 27 = ~ 60 l What is the target? 100 mg/dl if normal; 120 mg/dl if hypo; 80 or 90 mg/dl if pregnant For this person with hypoglycemia, pick 120 mg/dl l Correction bolus = BG – 120 mg/dl / 60

11. Case 1: DM 1 Agrees to CSII (A1C)

12. Managing Diabetes in Pregnancy Strict Metabolic Control is Essential Pregnancy should be planned

13. Glucose Targets In Pregnancy Fasting/preprandial glucose60 to 90 mg/dL Postprandial glucose< 120 mg/dL A1C < 5.5 %

14. Pump Infusion Sets Softset QRSilhouette

15. Helpful Hint Monitor Ketones Frequently: if BG > 180 mg/dl (avoid DKA) every AM Urine (starvation ketosis) Managing Diabetes in Pregnancy Strict Metabolic Control is Essential

16. Managing Diabetes in Pregnancy Insulin Requirements Increase 2–3 X’s Over Course of Pregnancy Insulin requirements increase: ~ 1 – 14 wks (may decrease or increase) ~ 24 – 26 wks (10% - 15% increase/ wk) ~ 30 – 32 wks * ~ 32 – 38 wks * *(decreasing insulin may mean placental failure)

17. Managing Diabetes in Pregnancy Insulin requirements decrease post delivery: Vaginal Delivery Reduce or suspend in delivery room - BR ~ 50% - May need to D/C BR for 12 – 24 hrs. - Check BG frequently to avoid hypoglycemia C-Section Suspend insulin delivery in OR at clamp of cord Resume basal 1-h later at pre-pregnancy rate

18. Case 1: DM 1 on CSII Pregnant (A1C)

19. Case 1: DM 1 Agrees to CSII l Patient loves the pump l No more migraines from hypoglycemia l Patient delivered at 37 weeks of pregnancy healthy boy with A1C at 5.2 to 5.5%

20. Case 1: Why has she done well l Pregnancy was planned l On CSII l SMBG with recording 7 to 8 times per day l Knows glycemic goals l Knows CHO counting l Follows up every 4 weeks l Faxes 2 times per week

21. Case 1: Specific Factors l Weight: 138 to 159 pounds l Basal: 12.4 to 14.2 units per day l Bolus: (I/C Ratio) 1/1 to 1.5/1 to 2/1 l Correction factor: BG-120/60 to BG-100/60 to BG-90/40 l Eyes, MicroAlb/Cr, BP, T4, TSH all normal

29. History - 28 yo bf - Type 2 X 4 yrs. - 1 st Pregnancy - NPH (95 u BID) & R (175u/d) - Wt. 313 lb. Ht. 68”- HbA1c: 6.6% Referred at 16 wks gestation No previous PNC Fair control pre-pregnancy on oral agents (BG ~ 120 mg/dL) BG consistenly > 160 mg/dl (past 2 – 3 wks) A1C 7.0% Case 3: Type 2 Diabetes Pregnant

30. Initial Therapy -Change to Lispro at higher doses ( 210u/d) -Record and fax Follow-up - Seen in clinic 7 days later - BG consistently > 140 mg/dL Case 3: Type 2 Diabetes Pregnant

32. Case 2: New to a Pump l Wgt 325 lbs; Ht 68”; on 400 units total dose l What is the starting dose on pump? l Two methods: 1) TDD x 75% = 300 units 2) Wgt in lbs. x 0.23 = 75 units l I picked the lower dose

33. Initial Basal Rates: 12am @ 1.7u/hr Set Meal Bolus 20 to 24 u / Meal Sliding Scale 1 u / 10 mg/dL > 100 CSII Therapy Initiated - 20 wks Case 3: Type 2 Diabetes Pregnant

35. 25 Wks -BG 60 to 80 fasting, 120 to 160 PC New Insulin Regimen Delivery - Hypertension; labor induced @ 37 wks - Delivered 7 lb. 9 oz. Male -BG 40 in recovery room Set Meal Bolus 25 to 30 u/Meal Sliding Scale 1 u / 10 mg/dL > 100 Basal Rates 12am 1.6 u/h 8am 2.0 u/hr Case 3: Type 2 Diabetes Pregnant

36. Managing Diabetes In Pregnancy Breast Feeding Recommended Dietary Allowance - Calorie intake - similar to pregnancy BG may drop 50 – 100 mg/dl during feeding - Avoid Hypoglycemia - Temporary Basal Rate - Snack (~20 – 30 gm) - Check BG before & after each feeding

37. Billing l Get paid for what you do l Use your codes and negotiate for coverage l Detailed visit: 99214 l Prolonged visit with contact plus above: 99354 or 99355 (insulin start or pump start) l Prolonged visit w/o contact plus above: 99358 or 59 (faxes, phone calls, emails)

38. Case 4: DM 2 Poorly Controlled l 58 year old female presented with a 12 year history of poorly controlled, insulin treated diabetes l Ht 66’’, Wt 174#, BMI 28, C-peptide 2.1 l A1C 10.4% on 165 units per day (70/30 BID) l Added troglitazone, metformin, glimepiride to MDI insulin l A1C 7.7 to 12.6% over 3 years

39. Case 4: DM 2 Poorly Controlled l Admitted twice for IV insulin and fasting with short lived success (A1C to 7.6% but back up to 12.6%) l Tried weight watchers and appetite suppressants; no help l Decided to try CSII

40. Case 4: DM 2 on CSII, A1C Results

41. Case 4: DM 2 Poorly Controlled l Patient loves the pump l On 110 units per day consuming 2 meals only per day (1.4 units per kg or 0.6 units per lbs) l Also on rosiglitazone 4 mg/day

42. Glycemic Control in Type 2 DM: CSII vs MDI in 127 patients l A1C 7.0 7.2 7.4 7.6 7.8 8.0 8.2 8.4 CSIIMDI Baseline End of Study (24 wks) Raskin, Diabetes 2001; 50(S2):A106

43. Change in scores (raw units) from baseline to endpoint -505101520253035 Convenience Less burden Less hassle Advocacy Preference General satisfaction Flexibility Less life interference Less pain Fewer social limitations MDICSII CSII vs MDI in DM 2 Patients Testa et al. Diabetes. 2001;50(suppl 2):1781

44. Pump Use in Children Is Increasing l ~ 14,000 children using pump therapy 10% of all children with diabetes l Penetration as high as 50% in some pediatric clinics l Increasing use in younger children l Current outcomes indicate CSII is safe and effective l Increasing acceptance likely due to DCCT findings as well as the introduction of smaller, safer insulin pumps

45. Challenges Unique to Children l Changing insulin requirements l Dawn Phenomena l Daily changes in activity levels l Phases of development l Puberty l Social concerns/depression

46. Diabetes in Younger Children Present Unique Challenges l Unpredictable food intake and activity l Imprecision of small insulin doses l Inability to convey hypoglycemia symptoms l Frequent viral infections

47. Challenges Unique to Teens l Struggle for independence l Growth and body changes l Identity l Peer relationships, alcohol, drugs, sex l Hectic schedules l Driving l College l Changes in psyche (mood swings )

48. Basal Rates Vary as a Child Grows l Pre-pubertal children Highest rate (as much as 2x) from 9p-12a Lowest rate from 3a-7a* l Pubertal children Highest rates between 3a-9a and 9p-12a* l Easiest to start with one rate l Make changes after the first night based on SBGM Conrad et al., Diabetes, 2000, 49 (Suppl 1):A101.

49. Bolus Doses l Use the smart pump functions Target at 100 mg/dl Carb dose calculator Correction dose l Keep it simple l Determine what patient is willing and or able to do

50. Carbohydrate:Insulin Ratios l Grams vs. Servings of CHO (exchanges) l Realistic starting meal plan l Have the family pick a plan that fits their lifestyle l Add dual wave option when able and willing

51. Avoiding DKA l Give a pen with the pump l Instruct that any time the patient feels nauseated or has abdominal pain -- change the site l Blood sugar is greater than 250 mg/dl Take correction dose Check for ketones Recheck in 60 minutes If coming down, leave alone If not, take a shot and change the site

52. Avoiding Hypoglycemia l Frequent blood glucose monitoring l Occasional 3 am checks l Consider re-adjusting glycemic goals for hypoglycemic unawareness l Bolus frequency Utilize Bolus calculator with active insulin to prevent stacking

53. Pumps in School l Leave class less often l School nurse responsibilities l Parent responsibilities l Bolusing in school l Alternatives for younger children l Leave insulin pen in school for problems

54. Highs and School l Blood sugar greater than 250 mg/dl before school –Change the site l Blood sugar greater than 250 mg/dl during school –Check for ketones –Take a bolus Bolus Calculator –Recheck in 60 minutes If not coming down, take insulin with a pen and change the site when child gets home

55. Case 5: Persistent Hypoglycemia on CSII l 42 year old male on pump for 6 years develops hypoglyemia ~5pm with no bolus since 12pm; he also has hyperglycemia upon awakening but all other BG’s in range. Basals 12am 0.8; 4am 1.4; 9am 0.8 l What do you do?

56. Case 5: Persistent Hypoglycemia on CSII l Basals changed 12am 0.8; 4am 1.6; 8am 0.8; 2pm 0.6; 7pm 0.8 l Hypoglycemia persists with now seizures and one MVA at 6pm l What now? l Insulin antibodies negative

57. Case 5: Persistent Hypoglycemia on CSII l Basals changed again 12am 0.8; 4am 1.8; 8am 0.8; 2pm 0.4; 8pm 0.8 l Hypoglycemia persists with another seizure at 6pm l What now?

58. Case 5: Persistent Hypoglycemia on CSII l The problem is the pump time is reversed; 6am is actually 6pm l Always verify all pump functions (time, basal, bolus, syringe placement, insulin in reservoir, tubing, and site when evaluating problems).

59. Pump Therapy Indications l A1C >6.5% l Frequent hypoglycemia l Dawn phenomenon l Exercise l Pediatrics l Pregnancy l Gastroparesis l Hectic lifestyle l Shift work l Type 2 Marcus. Postgrad Med. 1995.

60. Current Candidate Selection Patient Requirements –Willing to monitor and record BG –Motivated to take insulin –Willing to quantify food intake –Willing to follow-up –Interested in extending life

61. Pump Follow-up Procedures –Monitor, record, and report glucoses Pre and post meal Overnight (periodically) –Contact as needed Phone, fax, e-mail –Office visits First infusion set change 1-2 weeks later with RD, RN, or MD and PRN –After stable Quarterly visits ADA: Clinical Practice Recommendations, 2003.

62. If on Smart Pumps and not at Goal l Post meal too high Lower CIR (Carb to Insulin Ratio) l All BGs too high Lower target and / or change CF (ISF) l Fasting or pre meal too high Increase basal