TABLE 1.

Sheridan Health Services’ U-500R Insulin Management Protocol

Purpose: To establish an insulin titration and tracking process for patients with diabetes receiving insulin.
I.People responsible:
The clinical pharmacist will provide oversight of the processes described in this protocol. Student pharmacists will be directly involved in managing individual patients enrolled in the Insulin Management Program as described below.
II.Timeline for initiation:
October 16, 2014
III.Timeline for evaluation:
Every 6 weeks with the start of a new student who will be managing patients enrolled in the insulin management program.
IV.Practices:
a. For patients who are requiring high doses of U-100 insulin (e.g., >200 units per day), using U-500 should be considered if the patient is:
  • i. Adherent with medications and follow-up visits

  • ii. Has no or minimal cognitive impairment

  • iii. Is able to describe signs/symptoms consistent with hypoglycemia

  • iv. Is willing to have in-person or phone consultations weekly with student/pharmacist or provider

b. For patients referred to the U-500 Insulin Management Program, during the first visit, the student, pharmacist, or practitioner will:
  • i. Determine total daily dose of U-500 by adding up the current total daily dose of U-100 insulin, dropping the U-100 dose by 20% and then dividing by 5 (U-500 is equivalent to 500 units/mL, and all other insulins are U-100, equivalent to 100 units/mL)

  • ii. Determine the frequency of the U-500 based on the total daily dose of U-100

    • 1. 200–300 units/day of U-100 = BID dosing (60/40 with 60% of total daily dose before breakfast and 40% before dinner)

    • 2. 300–750 units/day of U-100 = TID dosing (40/30/30 with 40% of total daily dose before breakfast, 30% before lunch, and 30% before dinner)

  • iii. Assess how patient manages hypoglycemia and review or provide the Rule of 15 hypoglycemia management education

  • iv. Assess the level of physical activity since the last visit, provide education regarding benefits of physical activity, and have patient set personal physical activity goals

  • v. Assess current diet, determine whether patient is willing to eat a bedtime snack if needed, provide education regarding diet, and have patient set personal dietary goals

  • vi. Educate the patient that all other insulins will need to be discontinued with the initiation of U-500

  • vii. Educate the patient that he or she will need to check and record a fasting blood glucose every morning, a 2-hour postprandial blood glucose every day (rotate among breakfast, lunch, and dinner), and a bedtime blood glucose every night

  • viii. Provide 0.5-cc syringes to patient if patient only has 1-cc syringes at home and explain the importance of using the 0.5-cc syringes; have patient demonstrate how much insulin will be drawn up to ensure understanding and proper dosing

  • ix. Verify that patient understands the U-500 dosing by having him or her tell you how many units will be administered with each dose, what s/he will do with the other insulins (discontinue use), and how s/he plans to manage hypoglycemic episodes and describe personal goals regarding physical activity and diet for the next week

c. During subsequent visits, the student, pharmacist, or practitioner will:
  • i. Obtain the blood glucose values for fasting, 2-hour postbreakfast, 2-hour postlunch, 2-hour postdinner, and bedtime

  • ii. Determine U-500 dose adjustment:

    • 1. Divide 1,650 by total daily basal insulin dose to determine insulin resistance (or the blood glucose drop associated with 1 unit of insulin)

    • 2. Calculate the number of units required to achieve postprandial blood glucose of 180 mg/dL after the most problematic meal based on insulin resistance (calculated above) to estimate likely future insulin needs

    • 3. If postprandial blood glucose averages are >180 mg/dL, consider adding 0.1–0.2 mL of U-500 in the morning based on expected glucose reduction per the insulin resistance calculation

    • 4. If fasting glucose is >130 mg/dL and bedtime glucose is >150 mg/dL, consider increasing dose of bedtime U-500 by 0.1 mL and ensure that patient is taking a bedtime snack

  • iii. Assess whether patient had any hypoglycemic episodes and review the rule of 15 hypoglycemia management education

  • iv. Assess the level of physical activity since the last visit, provide encouragement so patient continues to engage in physical activity, and have patient set personal physical activity goals for the next week

  • v. Assess current diet, determine whether patient has been eating a bedtime snack, provide encouragement so patient continues to engage in good dietary habits, and have patient set personal dietary goals for the next week

  • vi. Reinforce that the patient will need to continue to check and record a fasting blood glucose every morning and a 2-hour postprandial blood glucose every day (rotate among breakfast, lunch, and dinner) and a bedtime blood glucose every night

  • vii. The student will document all above information as a note in the electronic health record; include glucose readings, average numbers, treatment changes, and education provided

  • viii. Weekly patient follow-up visits will continue as described above until patient’s glucose is controlled with a fasting blood glucose <130 mg/dL and postprandial blood glucose <180 mg/dL

  • ix. When all blood glucose levels are controlled, maintain the current dose until the next visit, stop weekly follow-up visits with the student or practitioner, and instruct patient to follow up with primary care provider

d. Hypoglycemia management:
  • i. Appropriate hypoglycemia management includes the Rule of 15:

    • 1. If patient feels bad, s/he should check blood glucose level

    • 2. If <70 mg/dL, s/he should eat 15 g of fast-acting carbohydrates (e.g., 4 oz fruit juice, 1/2 can regular soft drink, 4 glucose tabs, or 4 hard candies), wait 15 minutes, and recheck blood glucose; if still low, repeat 15 g of fast-acting carbohydrates and check blood glucose in another 15 minutes

    • 3. Patients should continue checking blood glucose and eating 15 g of carbohydrates until blood glucose is >70 mg/dL, and then eat a protein-rich meal

    • 4. If blood glucose continues to stay low despite appropriate management, seek emergency medical care

  • ii. If patient is having ≥2 hypoglycemia episodes within 1 week or ≥4 episodes within 1 month, discuss with clinical pharmacist or primary care provider

  • Sources:

  • 1. Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin determir in patients with type 2 diabetes: results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab 2007;9:902–913

  • 2. American Diabetes Association. Clinical practice recommendations 2012. Diabetes Care 2012;35:S1–S100