Initiating+Insulin+Therapy+in+DM2

** Patty Glatt, MD 10/09 ** Describe to patient as the "background" amount of insulin needed to run the fuel cells of their body's motor; Mealtime insulin is the extra insulin needed to handle the calories eaten. · **Add Basal “Background” insulin to oral regimen when A1C> 7.5-8.0 or FBS> 130 on maximum optimal oral regimen. Early use reduces CV/macrovascular complications.** Single basal dose sufficient when FBS elevated but orals control postprandial · **Basal therapy offers opportunity for patient efficacy, establish control FBS, transition to prandial and MDI insulin.** · **Oral DM agents: Continue MTF for weight control and insulin resistance. Caution w/TZD with insulin may ↑CHF. SU: Usually ↓ reduce to ½ max dose or DC.**
 * DM2 ADVANCEMENT TO INSULIN: When Patient Fails Oral Rx **
 * I. Initiating Single Basal Injection **


 * __ BLOOD GLUCOSE GOALS ON HOME MONITORING __**
 * Before meals: 90-130: w/o significant hypoglycemia**
 * 120-180: for elderly or patients with hypoglycemic unawareness**
 * 80-100: for those desiring tighter physiologic control**
 * After meals: under 160; Recommended under 135**
 * Bedtime: under 180; Recommended under 130**
 * Basal Insulin Treat to Target (T2T) Protocol **** : **
 * Achieves quicker A1C control with patient-driven titration. Avoids hypoglycemia**
 * GOAL: Titrate to FBS 90-130 mg/dl. (May adjust to tighter goal ≤110 individually per MD outside of protocol)**
 * How?**
 * 1. Start with minimum 10 units once daily Lantus/Glargine®, or Levemir/Detemir® or use guideline below to guide decision.** For 100kg, on average needs 40-50 units ultimately. Some start at 50% calculated for T2T.
 * 2. ↑ by 2 units until FBS <130; Option to ↑ by 4 units for FBS >180.**
 * When? ↑ insulin dose every 3-4 days** (“twice a week- patient picks”)
 * Warn: Hypoglycemia: ↓ by 4U or 10-15% if pre-breakfast glucose <70 or 2AM < 100**

· For patients unable to manage multiple dose injections for whatever reason · Improved control when Basal insufficient · Must eat at regular times and consistent calories; Skipping meals may lead to hypoglycemia · Premixed insulin offers no flexibility in adjustment of rapid portion
 * CALCULATING BASAL INSULIN DOSE (Usually dosed at bedtime)**
 * 0.5 U/kg normally**
 * 0.3 U/kg if concerned about risk of hypoglycemia (elderly, impaired renal, cardiac or hepatic function)**
 * 0.7 U/kg for presumed high insulin resistance (obesity, post-CABG, open wounds)**
 * II. Moving Beyond Single Basal Dosing **
 * After Basal T2T goal is reached, if HgbA1C remains >8.0, on add pre-meal "Prandial" insulin**
 * PREMIXED INSULIN(Humalog ®75/25 or Novolog ®70/30):**
 * Advantage of Premixed Insulins**
 * Disadvantages of Premixed Insulins**

· **Test glucose before meal and 2 hours after meal (from first bite) being targeted. Adjust twice a week until readings are within 40mg/dl of each other or goal achieved** · **Basal insulin Glargine usually given at bedtime. Adjust until FBS at target** · **Rapid-acting Lispro (Humalog) before each meal. May start with highest meal.** · **Add supplemental Lispro(Humalog) meal bolus insulin ( see Correction Factors below) if above target before giving prandial insulin**
 * PREMIXED INSULIN OPTIONS:**
 * 1.) Switch to single Premixed before dinner. Titrate Premixed T2T to 2hrpost prandial BS (based on start of meal).** Best when mostly elevated FBS and dinner or as initial Pre-mix when dinner is highest meal.
 * 2.) Advance to BID premixed Humalog®75/25 or Novolog ®70/30.** **Calculate TDD. Equally split between the prebreakfast and predinner injections.** Adjust according to SMBG. Occasional use for Humalog®50/50 for PM dose when more PM prandial insulin needed
 * 3.) AM Premixed Humalog ®75/25 or Novolog ®70/30 or NPH+Lispro(Humalog®)**
 * and PM (dinner or HS) NPH** When most elevations are daytime only.
 * III. **** MDI (Multi-Dose Injection) **** Basal +Bolus Regimen **** : **
 * Add pre-meal (Humalog®)Lispro, (Novolog®)Aspart, or (Apirdra)Glulisine® to single meal; start with largest meal. Gradually add additional largest meals, one at a time, until control. T2T for each prandial rapid insulin to 2hr postprandial.**
 * Features:**

· **Can be used with Type 2 DM and Type 1** · **Assoc w/ improved glycemic control leading resulting in less microvascular ds** · **Patient not tied to rigid eating schedule as with fixed-split** · **Elimination of dietary restrictions for those who do CHO counting**
 * Benefits **

· **Intensive management requires high level compliance and literacy to master** <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· **Frequent testing required or learning Carb counting**
 * Disadvantages **


 * __ Starting Basal/Bolus Insulin Regimen __**
 * 1. Calculate Total Daily Dose (TDD)-see box. [Alternative: 0.25-0.3 U/kg/d]**
 * CALCULATE THE TDD: ** Calculate the TDD based on patient size for premixed insulin
 * Dialysis patient (regardless if increased BMI): 0.3 U/kg/d**
 * Lean (BMI <25): 0.2 - 0.44 U/kg/d**
 * Overweight (BMI 25-30): 0.5 U/kg/d**
 * Obese (BMI >30): 0.6 -0.8 U/kg/d**


 * 2. Basal =50% of TDD, usually at bedtime; alternatively 30% TDD as NPH pre-breakfast and 20% TDD as NPH pre-dinner**
 * 3. Prandial (pre-meal) Bolus = 50% of TDD, as Lispro, Aspart, or Apirdra : 20% pre-breakfast, 10% pre-lunch, and 20% pre-dinner.**
 * __Alternative__: Basal 40%; Premeal = 20% each**


 * __Alternative__**
 * Basal = 0.125units/kg/d**
 * Pre-Breakfast Lispro= 0.025 units/kg/d**
 * Pre-Lunch Lispro = 0.0125 units/kg/d**
 * Pre-Dinner Lispro = 0.023 units/kg/d**
 * Patient Self Adjustment Instructions: **
 * SELF ADJUSTMENT FOR PREMIX AND MDI LISPRO **
 * When? Every 3-4 days. Adjust one dose at a time, usually first targeting dinner control.**
 * Target Goal: ↑ 1-2 units until at target goal 90-130 before meals.**

2 hr after Lunch → Before Lunch Lispro insulin or** **Before Lunch Premixed insulin**
 * WHEN? __ Uncontrolled Pre-Meal BG __→ __ Adjust __**
 * Before Breakfast Glucose→ Bedtime Basal or before dinner premixed**
 * Before lunch → Before Breakfast Lispro or Breakfast premixed
 * 2 hr after Dinner→ Before Dinner Lispro or Before** **Dinner premixed insulin**
 * Bedtime Glucose→ Before Dinner Lispro or** **Before Dinner premixed**


 * HOW MUCH? __ If Blood Glucose __→ __ Adjust Insulin __**
 * <20 below goal→ ↓ dose 3 Units or 10-15%**
 * At goal→ No Change**
 * over 5-10→ ↑ dose 1 unit**
 * over 11-19→ ↑ dose 2 units**
 * >20 above goal→ ↑ dose 3 Units**


 * TARGET GOALS:**
 * FBS, PREMEAL ≤ 130 ≥90, Recommended ˂100**
 * 2 HR POSTPRANDIAL ˂160 -135; recommend goal ˂135**
 * BEDTIME ˂130**
 * HYPOGLYCEMIA ANY ˂70**


 * http://care.diabetesjournals.org/content/32/1/193.full.pdf+html **
 * http://clinical.diabetesjournals.org/content/23/2/78.full.pdf+html **
 * http://care.diabetesjournals.org/content/31/7/1305.full.pdf+html **
 * MISCELLANEOUS PRACTICE TIPS **
 * **Fix lows values first. If only once or twice (not a pattern), ask about skipped meals. Adjust insulin in response to a //pattern//, not in response to a single abnormal value**
 * **Hypoglycemia: Review signs, symptoms, treatment and strategies for preventing**
 * **Give patients early opportunity to try a “dry practice insulin injection”**
 * **Offer pen devices to patients with low vision, poor hand control, true needle phobia. Medi-Cal TAR approval feasible for all of these. PAR for CCHP.**
 * **Don’t underprescribe low dose syringes. Better to use 0.5 for T2T**
 * **NEVER THREATEN A PATIENT WITH INSULIN**
 * **CCHP limits Lantus to 60 cc/month.**
 * **Pens 5/box**


 * IV. Pens and Needles **
 * PEN DEVICES **
 * Patient Selection **** : **
 * **Poor Dexterity- OA, neuropathy - Approved indication**
 * ** Mental or Cognitive impairment - Approved indication**
 * **Poor eyesight - Approved indication**
 * **Poor adherence –Requires explanation for authorization**
 * **Needle Phobia –Requires explanation for authorization**
 * __ Manufacturer / Product / Timing / Cost __**
 * AVENTIS-SANOFI / Solostar PrefilledPen Lantus (Glargine)/ ** ***Once daily/ HS $195**
 * Solostar PrefilledPen Apidra (Glulisine)*/ 15 mins AC **
 * Reusuable Opticlick*  ** Most used in EU
 * *Order B-D Ultra Fine Needles 31g ,3/16"mini, 5/16"short; 29g 1/2" standard **


 * NOVO-NORKDISK/ Novolog® Mix 70/30 FLEXPENǂ / 15 mins AC/ $195 **
 * Reusable Novolog ® (Aspart) FLEXPENǂ / 10 mins AC / $195 **
 * ǂOrder NovoFine 30,32 disposable needles or B-D Ultra Fine Needles 31g,3/16", 5/16";29g 1/2" standard **


 * LILLY/ Humalog® Mix 75/25 Prefilled Pen /1 5 mins AC / $195 **
 * Humalog® (Lispro) Prefilled Pen / 15 mins AC/ $195 **
 * Humulin® N (NPH) Pen/ 30 mins AC/ $140 **
 * Humulin® 70/30 (NPH/R) / 30 mins AC / $140 **
 * *Order B-D Ultra Fine Needles 31g ,3/16", 5/16";[29g 1/2" original] **

“Pre-filled” pens are disposable. All supplied 3ml=300 units/ pen or cartridge; 5 pen/per box. Max delivery is 60 units max per injection, except Solostar Lantus and Opticlick with max 80 units per injection [Innolet Device with large dial and numbers for use with Novolin ®(NPH/Reg) - soon to be discontinued] All covered on medical plans but require Prior Authorization/ Treatment Authorization Requests Store all unopened cartridges in refrigerator until use or expiration date; Store open unrefrigerated pen cartridges for 10-14 days. Good cost alternative are Prefilled Syringes for selective patients e.g. learning impaired, family members

<span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· Educate early that diabetes is a progressive disease; prepare your patient that most patients will eventually need insulin. <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· Oral medication only work when the body makes enough insulin. <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· Starting Insulin early is about reducing complications over 10 years (death, MI, Stroke, amputation). We can all agree on a goal to live a long healthy life. <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· Insulin allows a person the freedom to eat a relatively “normal” diet again <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· Insulin is the only “natural therapy” we have <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· Just one shot a day of insulin may be sufficient <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· Insulin does not require refrigeration <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· Starting insulin does not cause complications; untreated advanced disease does. <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· **INSULIN ALWAYS WORKs** ** VI. Addendum **
 * NEEDLES **
 * Gauge:** Thinness. Higher number refers to finer needle. Order highest gauge available for patient comfort
 * 30, 31 (“microfine”) gauge: needles are painless**
 * Lengths:** Thin patients can use shorter needles. Obese patients need longer needles.
 * 1/2" Standard (** comes in 29, 30, 31 gauge**) for more obese patients**
 * 5/16” Short (** comes in 28, 29, 20, 31 gauge**) for thinner patients**
 * 3/16" Mini **May be most comfortable for the
 * Volume: Don’t underprescribe.** Patient may not exceed their monthly insurance allotment
 * 0.3cc =** Low dose - up to 30 units. Best visibility if low dose used. May exceed dose if T2T pt.
 * 0.5cc **= Low dose- up to 50 units. Best for starting T2T to avoid running out of syringes
 * 1.0** cc = Standard- up to 100 units. Best if obeseT2T and likely will need high dose
 * V. Talking Points: **
 * OVERCOMING BARRIERS TO STARTING INSULIN TX **
 * Bolus Pre-prandial Insulin Correction Dose **
 * __Calculating the Insulin Sensitivity Factor__:**
 * Adjust blood glucose before/between meals as needed for deviations from goal. Approximation if patient is not well controlled on current insulin regimen.**

** APPROXIMATION OF INSULIN SENSITIVITY FACTORS: **
 * __ Patient Characteristic __ → __ Amount ↓BG/1U Lispro __**
 * Highly insulin sensitive and/or bad kidneys→ Lower 60-100 mg/dl**
 * Normally insulin sensitive → Lower 50 mg/dl**
 * Mild insulin resistance BMI> 25→ Lower 30 mg/dl**
 * Moderate insulin resistance BMI>30→ Lower 20 mg/dl**
 * Severe insulin resistance BMI>40→ Lower <10 mg/dl**


 * "RULE OF 1800"**
 * For patients well controlled, use the Rule of 1800 for a more precise patient-specific value. This is the amount of Lispro needed to bring current BG down to target BG.**


 * __“Rule of 1800” Insulin Sensitivity Factor__: To estimate expected drop in blood glucose for each unit of Lispro insulin, use the “1800 Rule”**
 * [Feasible to calculate only when pt. in reasonable control on known insulin regimen]**
 * 1.) To calculate the Correction Factor: Divide 1800 by total current Total Daily**
 * Dose insulin (TDD)= glucose mg/dl point drop for every unit of Lispro insulin.**
 * 2.) Current BG – Target BG (110)= # points over target.**
 * 3.) Divide this by “correction factor” (round # as needed).**

<span style="font-family: 'Times New Roman'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;"> <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· **To estimate the insulin required to cover the carbohydrate load of an upcoming meal. (CHO counting). Method used for intensive Bolus + 3X Prandial** <span style="font-family: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol; msobidifontfamily: Symbol; msofareastfontfamily: Symbol; msolist: Ignore;">· **Package labels and food lists with carbohydrate grams and portions sizes assist with this.**
 * INSULIN:CARBOHYDRATE CORRECTION FACTOR**
 * I:C ratio is the amount of carbohydrate covered by one unit of rapid-acting insulin analog (Lispro, Aspart). ** ** The insulin-to-carbohydrate ratio can be determined using the 500 rule (see below), in which the total daily dose of insulin (TDD) is divided by 500. Typically, insulin-to-carbohydrate ratios are in the range of 1U: 10-15 gram of carbohydrate. **
 * This method can be modified for patients who prefer a simpler method of counting carbohydrates or food intake. Patients round their carbohydrate choices to a 15 g portion size and count their carbohydrates in denominations of portions rather than grams. An example would be 1 unit of insulin per 1 portion of carbohydrate. **


 * __ The Carbohydrate Coverage “500 Rule __**** ”: **
 * Gives an approximation for how many grams of CHO will be covered by 1U of Lispro insulin.**
 * Divide 500 by the TDD of insulin (basal + bolus) to determine how many grams of carbohydrate will be covered by 1U of Lispro. This is this individuals “correction factor”.**

**__EXAMPLES OF CORECTION FACTORS__**
 * Calculating Carbohydrate Coverage with “500 rule”**
 * Example: Pt uses total 30 units per day (15 units Glargine and 15 units Lispro):**
 * 500/30= 17 grams carbohydrate covered by 1 unit of Lispro**
 * Therefore, for this patient, there CHO: Lispro insulin ratio is 17:1**


 * Calculating Insulin Sensitivity Factor- Example:**
 * Joe typically uses 30 units of glargine at bedtime, 10 units of lispro at breakfast, 5 units at lunch, and 15 units at dinner.**
 * TDD= 30glargine = 30lispro = 60 units insulin/day**
 * 1800/60 = 30**
 * Therefore every 1 unit of Lispro should drop Joe’s blood glucose 30 mg/dl.**
 * Or stated another way, for Joe, his insulin sensitivity correction factor is 30 mg/dl for each unit of Novolog (Lispro).This can be used to estimate what supplemental dose Joe will need for a pre-meal correction dose in addition to his usual dose if his pre-meal glucose value is exceeds target value.**


 * Calculating Bolus- Example:**
 * Joe has a tooth infection. His pre-lunch blood sugar has shot up to 240 from his usual 120. He needs a correction factor for 120mg/dl. Therefore, he needs 120mg/dl divided by 30mg/dl per 1 unit = __4 units__ Novolog //__for correction.__//__.__ Therefore Joe’s dose will be his usual 5 + 4 = __ 9 units__ Novolog before eating lunch.**

<span style="font-family: 'Times New Roman'; font-size: 12pt; mso-ansi-language: EN-US; mso-bidi-language: AR-SA; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">
 * Example:**
 * Calculating Pre-Prandial Correction with CHO counting and Bolus Correction: **
 * By way of example, consider a patient who has a target blood sugar before meals of 110, premeal glucose of 170, insulin-to-carbohydrate ratio of 1:15, and an insulin sensitivity factor of 1:30. This person is about to eat a meal estimated to contain 60 g of carbohydrate. He currently takes a dose of Glargine/Lantus every evening and a rapid-acting analog (lispro or aspart) before each meal. With the I:C ratio of 1:15 and 60 g of carbohydrate intake, this patient would require 4 units of rapid-acting insulin to cover the carbohydrates at this meal. With a premeal glucose of 170, target glucose of 110 and a 1:30 insulin sensitivity factor, an additional 2 units would be required as the correction factor. Four units of lispro or aspart will be needed to cover the carbohydrate intake, and an additional 2 units will be needed as a correction factor based on the premeal glucose, for a total dose of 6 units of lispro or aspart **** . **