Type 1 Diabetes Mellitus
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  • 1. Type 1 Diabetes Mellitus Jason Cavolina BS, MS, PharmD Candidate Arnold & Marie Schwartz College of Pharmacy and Health Sciences Long Island University Ambulatory II Clerkship
  • 2. Introduction
    • Diabetes mellitus (DM) is a group of metabolic disorders characterized by hyperglycemia and abnormalities in carbohydrate, fat and protein metabolism
    • Type I Diabetes:
      • Absolute deficiency in insulin
      • β -cell destruction
  • 3. Introduction
    • DM eventually -> microvascular and macrovascular complications
      • Microvascular : retinopathy, nephropathy, and peripheral neuropathy
      • Macrovascular : coronary heart disease (CHD), stroke, and peripheral vascular disease (PVD)
  • 4. Epidemiology
    • DM affects more than 170 million people worldwide
    • By 2010 this number will ↑ by as much as 50%
    • ~10% of patients with diabetes have type 1 DM
    • Cardiovascular morbidity in DM patients is 2-4 times greater than in non-diabetic patients
  • 5. Epidemiology
    • Average onset is in childhood or early adulthood (usually before 30 years of age)
    • Characterized by autoimmune destruction of pancreatic β -cells -> absolute insulin deficiency
    • Patients dependent on exogenous insulin
  • 6. Pathophysiology
    • Immune-mediated destruction of pancreatic β -cells
    • Certain antibodies detected in blood
      • Islet cell antibody (ICA)
      • Glutamic acid decarboxylase (GAD65) antibody
      • Insulin autoantibody (IAA)
    • HLA-DR3 and HLA-DR4 as well as DQA and DQB genes are strongly associated with type 1 DM
    • Strong familial genetic link
  • 7. Pathophysiology
    • Environmental triggers
      • Viral infections (mumps, influenza)
      • Early exposure to cow’s milk (bovine serum albumin)
      • Environmental toxins
      • Puberty
    • “ Honeymoon” phase -> transient remission
    • Hyperglycemia occurs when 80%-90% of β -cells are destroyed
  • 8. Clinical Presentation
    • Moderate to severe symptoms
    • Symptoms progress rapidly
    • Onset usually childhood or adolescent
    • But, can occur at any age
    • Signs and Symptoms:
    • Polyuria
    • Polydipsea
    • Polyphagia
    • Diabetic Ketoacidosis (DKA)
    • Unexplained weight loss
  • 9. Criteria for Screening
    • Screening is not recommended
    • Routine testing for immune markers is not recommended:
      • Cut off values for immune markers assays have not been established.
      • No consensus as to what action should be taken when a positive autoab test result is obtained.
  • 10. Diagnostic Elements
    • DKA
    • Symptoms of diabetes and a casual plasma glucose ≥ 200 mg/dl
    • Fasting Plasma Glucose (FPG) ≥ 126 mg/dl
      • Impaired Fasting Glucose (IFG)
    • 2-h plasma glucose ≥ 200 mg/dl after an OGTT
    • These criteria should be confirmed by repeat testing on a different day
  • 11. Pharmacotherapeutic Goals Glycemic Control <180 mg/dL Peak postprandial capillary plasma glucose 90-130 mg/dL Pre-prandial capillary plasma glucose <7.0 – 6.5 % Hemoglobin A 1C
  • 12. Desired Outcomes
    • Reduce risk for microvascular and macrovascular complications
    • Reduce mortality
    • Achieve glycemic control
    • Improved quality of life
  • 13. Overview of DM Management
    • Treatment regimens should be individualized
    • Type 1 DM
      • Lifetime insulin therapy
      • Lifestyle modification
        • Diet
        • Exercise
  • 14. Medical Nutrition Therapy Adjust based on age, weight and height. Total calories < 300 mg/d (< 200 mg/d in dyslipidemia) Cholesterol Up to 20% of total cal. Monounsaturated fat ~10% of total cal. Polyunsaturated fat < 10% of total cal (< 7% in dyslipidemia) Saturated fat 25-35% of total cal. Total fat 15-20% of total cal. Protein ~50-60% of total calories Carbohydrate Recommended Intake Nutrient
  • 15. Exercise Recommendation
    • ADA: 30-60 min. of aerobic activity 3-4 times a week
    • Surgeon General Report: Accumulate 30 min. of moderate physical activity on most days of the week
    • Exercise regimens should be individualized
  • 16. Pharmacotherapy in Type 1 DM
    • The primary therapy for type 1 DM is insulin therapy
    • Four basic forms of insulin:
      • Rapid-acting
      • Short-acting
      • Intermediate-acting
      • Long-acting
  • 17. Insulin
    • Which one should be used?
      • Individuals lifestyle
      • Physicians/Pt preference
      • Patients blood sugar level
  • 18. Which one should be used?
    • Source of insulin?
      • By January 2006, pork/beef insulin for human use will no longer be manufactured or marketed in the U.S.
    • How soon it starts working -> onset
    • When does it reach the highest -> peak
    • How long it lasts in body -> duration
  • 19. Rapid-acting Insulin
    • Type Onset (h) Peak (h) Duration (h) Appearance
    • insulin lispro 15-30 min 1-2 3-5 Clear
    • HUMALOG®
    • insulin aspart 15-30 min 1-2 3-5 Clear
    • NOVOLOG®
    • insulin glulisine 15-30 min 1-2 3-5 Clear
    • APIDRA®
  • 20. Rapid-acting Insulin
    • Dosage forms:
      • HUMALOG & NOVOLOG
      • Pen, U-100 vial, or 1.5 ml or 3 ml pen cartridge
      • APIDRA
        • U-100 Vial
  • 21. Rapid-acting Insulin
    • Inject within 10-15 minutes of meal
    • Better efficacy in ↓ post prandial blood glucose
    • Minimizes delayed postmeal hypoglycemia
    • Normally used in regimens with intermediate or long-acting insulin
    • Rapid-acting insulin can be mixed with NPH and lente -> the mixture should be injected within 15 minutes prior to a meal
  • 22. Short-acting Insulin
    • Type Onset (h) Peak (h) Duration (h) Appearance
    • Regular 0.5-1.0 2-3 3-6 Clear
    • HUMULIN R ®
    • NOVOLIN R ®
  • 23. Short-acting Insulin
    • Dosage forms:
    • HUMULIN R
      • U-100 vial, 10 ml vial or U-500, 20 ml vial
    • NOVOLIN R
      • Insulin pen, U-100 vial, or 3 ml pen cartridge, and Innolet
  • 24. Short-acting Insulin
    • Relatively slow onset of action when given SQ
    • Inject SQ 30 minutes prior to meal to achieve optimal post prandial glucose control and to prevent delayed postmeal hypoglycemia.
    • Eating within a few minutes after or before injecting is discouraged because it substantially ↓ the ability of that insulin to prevent a rapid rise in blood glucose and may ↑ the risk of delayed hypoglycemia.
  • 25. Intermediate-acting Insulin
    • Type Onset (h) Peak (h) Duration (h) Appearance
    • NPH 2-4 4-6 8-12 Cloudy
    • HUMULIN N®
    • NOVOLIN N®
    • Lente 3-4 6-12 12-18 Cloudy
    • HUMULIN L®
  • 26. Intermediate-acting Insulin
    • Dosage forms:
    • HUMULIN N
      • U-100 vial, prefilled pen
    • NOVOLIN N
      • U-100 vial, prefilled pen, and Innolet
    • HUMULIN L
      • U-100 vial
  • 27. Long-acting Insulin
    • Type Onset (h) Peak (h) Duration (h) Appearance
    • Glargine 4-5 Peakless 22-24 Clear
    • LANTUS®
    • Available as U-100 vial and Pens
  • 28. Long-acting Insulin
    • LANTUS
      • ‘ peakless’’ analog -> less nocturnal hypoglycemia than NPH when given at bedtime
      • Usually given once a day only
    • Horizon
      • Insulin Detemir (Levemir ®)
      • ~ peakless, ~ 24 h duration, Clear
  • 29. Premixed Insulin
    • Fixed ratio insulins are dosed according to patient needs
    • 15 minutes before meals
    • Premixed insulin analogs
      • HUMALOG Mix 75/25 (75% neutral protamine lispro, 25% lispro)
        • U-100 vial, prefilled pen
      • NOVOLOG Mix 70/30 (70% aspart protamine suspension, 30% aspart)
        • U-100 vial, prefilled pen, 3 ml pen cartridge
  • 30. Premixed Insulin
    • NPH-regular combinations
      • HUMULIN 70/30
        • Vial, prefilled pen
      • NOVOLIN 70/30
        • Vial, pen cartridge, Innolet
      • HUMULIN 50/50
        • Vial
  • 31. Insulin Regimens
  • 32. Insulin Regimens
  • 33. Symlin® (Pramlintide acetate)
    • Antihyperglycemic agent
    • Synthetic analog of human Amylin
    • Amylin: Naturally secreted from β -cell
      • Suppresses glucagon secretion
      • slows gastric emptying time
      • Causes satiety -> potentially to weight loss
  • 34. Insulin Adverse Reactions
    • Lipoatrophy : loss of fat at injection site due to antibody formation leading to breakdown of fat in the area of injection ( need to rotate sites!)
    • Hypertrophy : increase in fat mass at the site, the area is anesthetized , however leads to erratic insulin absorption
    • Resistance : require large amounts of insulin to get desired effect, due to antibody formation
  • 35. Insulin Adverse Reactions
    • Hypoglycemia:
    • Blood glucose < 50mg/dl
    • Hypoglycemia S&S
      • Mild to moderate
    • Sweating
    • Drowsiness
    • Dizziness
    • Sleep disturbances
    • Palpitation
    • Anxiety
    • Tremor
    • Blurred vision
    • Hunger
    • Slurred speech
    • Restlessness
    • Depressed mood
    • Tingling in hands, feet, lips, or tongue
    • Irritabilty
    • Lightheadednes
    • Abnormal behavior
    • Inability to concentrate
    • Unsteady movement
    • Headache
    • Personality change
  • 36. Insulin Adverse Reactions
    • Hypoglycemia S&S: Severe
    • Disorientation
    • Unconsciousness
    • Seizures
    • Death
  • 37. Hypoglycemia
    • Treatment:
    • Rule of 15 -> 15g of carbohydrates every 15 minutes until BG is greater than 70mg/dl, then follow with a simple meal
  • 38. Insulin Adverse Reactions
    • Foods that will provide 10g of carbs
      • ½ cup of orange juice or soda
      • Sugar: 2 teaspoons or 2 cubes
      • Glucose tablets: 2-4 tablets
      • Apple juice: 1/3 cup
    • Foods to avoid
      • Ice cream, candy bars, cookies, cakes
      • Complex carbs slowly absorbed
    • If unconscious : Glucagon 1mg SQ, IM, or IV and Dextrose 50% 50ml infusion
  • 39. Diabetic Adverse Event
    • DKA
      • Precipitated by a stressful event
        • trauma, infection, surgery or myocardial infarction
        • increased release of cortisol, glucagon, and catecholamines ( ↑ production of glucose and ketoacids)
  • 40. Diabetic Adverse Event
    • Signs and Symptoms
      • Hyperglycemia (glucose: 250-800mg/dl)
      • Volume depletion
      • High anion gap metabolic acidosis
      • Hypokalemia
      • Glucosuria
      • Urine ketosis
      • Hyperosmolality
      • Patients present with tachycardia, polydipsia, abdominal pain, nausea, vomiting and coma
  • 41. Monitoring Diabetes
    • Assess nutrition and physical activity regularly
    • Blood pressure each visit
    • Alcohol and smoke cessation
    • Self-Monitoring Blood Glucose
    • Foot care
    • Assess for peripheral neuropathy
    • Monitor HgA1c every 3-6 months
    • Lipid profile yearly
    • Annual dilated eye examination
    • Thorough annual physical exam Renal assessment for microalbuminuria
    • Cardiovascular complications
    • Influenza vaccine yearly
    • Pneumococcal vaccine every 5 years
    • Assess for PVD
    • Retinopathy
  • 42. Counseling Points
    • Mixing Insulin:
      • Pt’s well controlled on mixed insulin regimen -> maintain their standard procedure.
      • No other medication or diluents should be mixed with insulin.
      • Glargine (LANTUS) should not be mixed with any insulin.
      • Use of commercially available premixed insulins may be used if insulin ratio is appropriate to Pt insulin requirement.
      • NPH and short-acting insulin when mixed can be used immediately or stored for future use
  • 43. Counseling Points
    • Clear insulin drawn into syringe first
    • Rapid-acting insulin can be mixed with NPH and lente
    • When rapid acting insulin is mixed with either an intermediate or long-acting insulin -> mixture should be injected within 15 min before meal.
    • Mixing of short-acting and lente insulin is not recommended except for Pt already adequately controlled on such mixture.
    • Phosphate-buffered insulins (NPH) should not be mixed lente insulin
  • 44. Counseling Points
    • Storage :
    • Unopened vials, cartridges and pens.
      • If refrigerated use until expiration date
      • If room temperature, use within 28 days
    • Opened
      • Vials within 28 days at room temperature or refrigerated
      • Pen and pen cartridges within 28 days at room temperature ( do not refrigerate )
    • Do not use if insulin has been frozen or exposed to high temperatures (<2 º C or > 30 º C).
    • Excess agitation should be avoided
  • 45. Insulin Administration
    • Check vial before use to inspect for changes -> loss of potency
    • Vial and pens should be rolled in palms of hands before drawing with needle -> except with rapid and short acting insulin
  • 46. Insulin Delivery Devices
    • Insulin pens
      • Pens with cartridges -> users turn a dial to select the desired dose of insulin -> press a plunger on the end to deliver insulin
      • Needle should be embedded within skin for 5 seconds after complete depression of plunger
      • Air bubbles in pen reduces rate of insulin flow
      • Avoid leaving needle on pen between injections and prime needle with 2 units of insulin
  • 47. Counseling Points
    • Injection Site:
    • Subcutaneous tissue of upper arm.
    • Anterior and lateral aspects of the thigh, buttocks, and abdomen
    • IM not recommended
    • Rotation of injection site recommended
      • Prevent lipohypertrophy and lipoatrophy
      • Rotating within one area is recommended
  • 48. Injection Site
    • Variable absorption between sites
      • Abdomen > arms >thighs > buttocks
    • Exercise ↑ rate of absorption
    • Areas of lipohypertrophy have slower absorption.
    • IM > SC absorption
  • 49. Preventing Painful Injections
    • Inject insulin at room temp
    • Make sure no air bubbles remain in syringe before injection
    • Wait for topical alcohol to evaporate before injection
    • Relax muscle at injection site at time of injection
    • Penetrating skin quickly
    • Not changing direction of needle during insertion or withdrawal
  • 50. Conclusion
    • Diabetes complex disease state
    • Requires diligent daily monitoring
    • Requires coordination of care
    • Requires strong patient knowledge base
    • Requires enthusiastic pharmasist intervention
  • 51. Questions
  • 52. References
    • http://guidelines.gov/summary/summary.aspx?doc_id=7212&nbr=004306&string=diabetes , accessed 03/06
    • Treatment Guidelines from The Medical Letter. Volume 3, Issue 36. August 2005
    • Symlin, [Package insert] Amylin Pharmaceuticals, Inc. San Diego CA
    • http://products.sanofi-aventis.us/apidra/apidra.html , accessed 03/06
  • 53. References
    • Harrison's Principles of Internal Medicine - 16th Ed. (2005)
    • American Diabetes Association: Evidence based nutrition principles and recommendations for the treatment and prevention of diabetes and realted complications (Position statement). Diabetes Care. 2002;25: S50-60.
    • http://www.diabetes.org/home.jsp , accessed 03/06