II. Indications

  1. See Type II Diabetes Mellitus
  2. Insulin Augmentation (basal Insulin only starting at 0.1 to 0.3 units/kg)
    1. Symptomatic Hyperglycemia or Hemoglobin A1C >9% despite non-Insulin therapy AND
      1. One or two oral Oral Hypoglycemic agents OR
      2. GLP-1 Agonist and at least one Oral Hypoglycemic agent
  3. Insulin Replacement (basal and Bolus Insulin starting at 0.6 to 1.0 units/kg)
    1. Blood Glucose >300 to 350 mg/dl OR
    2. Hemoglobin A1C >10-12% OR
    3. Failure to meet Blood Glucose goals despite Insulin Augmentation

III. Adverse Effects

  1. Weight gain
    1. Consider basal Insulin with GLP-1 Receptor Agonist, Metformin or Pamlintide to mitigate weight gain
    2. Avoid other Medications Associated with Weight Gain
  2. Hypoglycemia
    1. See Hypoglycemia Management in Diabetes Mellitus
    2. Patient Education on recognition and management of Hypoglycemia
    3. Exercise caution when Hemoglobin A1C <7.4%, severe Renal Insufficiency
    4. Do not use Insulin Secretagogues (e.g. Sulfonylureas, Meglitinide) with Bolus Insulin
    5. Analogue basal (e.g. Lantus) and bolus (e.g. Lispro) agents are lower risk for Hypoglycemia than regular and NPH

IV. Protocol: Identify Blood Glucose goals

  1. No predisposition to Hypoglycemia (goals per ADA, and AACE/ACE in parentheses)
    1. Pre-meal or Fasting: 80-130 mg/dl per ADA (or 70 to 110 mg/dl per AACE/ACE)
    2. Two hour post-prandial Glucose <180 mg/dl per ADA (or 140 per AACE/ACE)
      1. Blood Glucose 20-40 mg/dl above pre-meal Glucose
    3. Bedtime: 100-140
    4. Hemoglobin A1C: <7-8% (Normal 4.0 - 6.0%)
  2. Predisposition for Hypoglycemia (Comorbid conditions)
    1. Pre-meal/Fasting: 100-150
    2. Hemoglobin A1C: 7-8%

V. Protocol: Starting Basal Only Insulin (Augmentation) and Advancing to Basal/Bolus Insulin (Replacement) in Type II Diabetes

  1. Precautions
    1. Requires regular Blood Glucose Monitoring and compliant, reliable patient and family
    2. Educate on home Hypoglycemia Management (Glucose tablets, Glucagon)
  2. Step 0: 0-0-0-G (Basal Only Protocol - Insulin Augmentation)
    1. Basal Insulin
      1. Preparations
        1. Insulin Glargine (G) such as Lantus, Levemir or
        2. NPH (if cost is a concern)
          1. Also start with single dose at bedtime (despite shorter half life)
      2. Starting dose options
        1. Basal Insulin 10 units at night OR
        2. Basal Insulin 0.1 to 0.2 units/kg/day (or 50% of total daily sliding scale dose)
      3. Titrate
        1. Increase basal Insulin by 2-4 units or 10-15% once or twice weekly until Blood Glucose controlled
        2. Go to Step 1 when Blood Glucose not at goal despite basal Insulin >0.5 units/kg/day
        3. Hypoglycemia should prompt decrease Insulin 4 units or 10-20% (and address cause)
    2. Other agents to continue
      1. Oral Insulin sensitizer (e.g. Metformin or Glucophage) and
      2. Oral Insulin Secretagogue (e.g. Glipizide)
        1. Stop when Bolus Insulin (e.g. RA) is initiated more than once daily
  3. Step 1: 0-0-RA-G (Basal Plus Protocol)
    1. As an alternative, may use premixed Insulin twice daily (see protocol below)
    2. Add 0.1 units/kg (or 4 units or 10% of basal dose) Bolus Insulin before largest meal
      1. Lispro or Aspart (rapid acting or RA) or
      2. Regular Insulin (if cost is a concern)
        1. Avoid in Stage IV or Stage V significant Chronic Kidney Disease
        2. Avoid if history of severe Hypoglycemia
    3. Other dosing
      1. Decrease Insulin Glargine by 0.1 units/kg if Hemoglobin A1C <8%
      2. Continue Insulin sensitizer (e.g. Metformin)
      3. Caution with Insulin Secretagogue (e.g. Glipizide)
        1. May be continued with caution once per day opposite the rapid acting Insulin dose
        2. Consider discontinuing in the elderly or other risks of Hypoglycemia
    4. Titration
      1. Check Blood GlucoseFasting, before rapid acting (RA) dose and at bedtime
      2. Increase Bolus Insulin by 1-2 units or 10-15% once or twice weekly until Blood Glucose controlled
      3. Hypoglycemia should prompt decrease Insulin 2-4 units or 10-20% (and address cause)
  4. Step 2: RA-0-RA-G (Basal-Bolus Protocol)
    1. Add 0.1 units/kg (or 4 units or 10% of basal dose) rapid acting (RA) Bolus Insulin before 2nd largest meal
    2. Decrease Insulin Glargine by 0.1 units/kg if Hemoglobin A1C <8%
    3. Continue Insulin sensitizer (e.g. Metformin)
    4. Stop Insulin Secretagogue (e.g. Glipizide, Meglitinide)
    5. Check Blood GlucoseFasting, before rapid acting (RA) doses and at bedtime
  5. Step 3: RA-RA-RA-G (Basal-Bolus Intensive Protocol)
    1. Add 0.1 units/kg (or 4 units or 10% of basal dose) rapid acting (RA), Bolus Insulin before 3rd largest meal
    2. Decrease Insulin Glargine by 0.1 units/kg if Hemoglobin A1C <8%
    3. Check Blood GlucoseFasting, before rapid acting (RA) doses and at bedtime
  6. Precautions
    1. Keep Insulin split into 50% basal and 50% bolus

VI. Protocol: Starting Basal Insulin (e.g. Lantus) and Bolus Insulin (e.g. Lispro)

  1. Step 0: Adjust oral medications
    1. Stop Insulin Secretagogue (Sulfonylurea, Meglitinide) when on twice daily Bolus Insulin
    2. Continue Insulin sensitizers (Metformin, Glitazone)
  2. Step 1: Choose a 24 hour basal Insulin (once daily):
    1. Detemir (Levemir)
    2. Glargine (Lantus)
  3. Step 2: Choose a Bolus Insulin (pre-meal Insulin):
    1. Regular Insulin (Novolin R, Humulin R)
    2. Glulisine (Apidra)
    3. Lispro (Humalog)
    4. Aspart (Novolog)
  4. Step 3: Starting dose
    1. Hemoglobin A1C <8
      1. Basal Insulin 0.1 units/kg once daily AND
      2. Bolus Insulin 0.1 units/kg divided equally before meals (start before breakfast and dinner)
    2. Hemoglobin A1C 8-10
      1. Basal Insulin 0.2 units/kg once daily AND
      2. Bolus Insulin 0.2 units/kg divided equally before meals (start before breakfast and dinner)
    3. Hemoglobin A1C >10
      1. Basal Insulin 0.3 units/kg once daily AND
      2. Bolus Insulin 0.3 units/kg divided equally before meals (start before breakfast and dinner)

VII. Protocol: Starting Basal/Bolus Insulin using NPH

  1. Background
    1. Other regimens less complicated and therefore preferred
    2. However, NPH and Regular Insulin are least expensive Insulin options
  2. Step 0: Adjust oral medications
    1. Stop Insulin Secretagogue (Sulfonylurea, Meglitinide) when on twice daily Bolus Insulin
    2. Continue Insulin sensitizers (Metformin, Glitazone)
  3. Step 1: Starting dose
    1. Hemoglobin A1C <8: Total Insulin: 0.1 units/kg in AM and 0.1 units/kg in PM
    2. Hemoglobin A1C 8-10: Total Insulin: 0.2 units/kg in AM and 0.2 units/kg in PM
    3. Hemoglobin A1C >10: Total Insulin: 0.3 units/kg in AM and 0.3 units/kg in PM
  4. Step 2: Divide each Insulin dose into 1/3 bolus (e.g. Regular Insulin) and 2/3 NPH Insulin
  5. Step 3: Schedule 2 doses of Bolus Insulin (e.g. regular) and 2 doses of NPH daily
    1. Breakfast (50%): NPH Insulin (2/3) and Regular Insulin (1/3)
    2. Dinner (50%): NPH Insulin (2/3) and Regular Insulin (1/3)

VIII. Protocol: Starting Insulin using Premixed Insulin

  1. Step 0: Adjust oral medications
    1. Stop Insulin Secretagogue (Sulfonylurea, Meglitinide)
    2. Continue Insulin sensitizers (Metformin, Glitazone)
  2. Insulin preparations (for twice daily dosing)
    1. Lispro Mix 75/25 or
    2. Aspart Premix 70/30
  3. Starting dose
    1. Based on Insulin Glargine Regimen (Insulin Augmentation) as above
      1. Divide current basal Insulin dose into 2/3 AM and 1/3 PM or
      2. Divide current basal Insulin dose into 1/2 AM and 1/2 PM
    2. Based on current Hemoglobin A1C
      1. A1C <8: 0.1 units/kg in AM and 0.1 units/kg in PM
      2. A1C 8-10: 0.2 units/kg in AM and 0.2 units/kg in PM
      3. A1C >10: 0.3 units/kg in AM and 0.3 units/kg in PM
  4. Titration
    1. Check Blood GlucoseFasting, before Insulin dose and at bedtime
    2. Increase Insulin by 1-2 units or 10-15% once or twice weekly until Blood Glucose controlled
    3. Hypoglycemia should prompt decrease Insulin 2-4 units or 10-20% (and address cause)

IX. Protocol: Converting from Premixed Insulin to Basal Bolus Insulin

  1. Calculate total Insulin units/kg
    1. Total >1.5 units/kg: Lower total to 1.0 unit/kg
    2. Hemoglobin A1C <9: Decrease total Insulin by 10%
  2. Divide total Insulin Dosing
    1. Insulin Glargine: 50% of total Insulin
    2. Rapid acting: 50% of total divided across meals

X. Protocol: Insulin Adjustments

XI. References

  1. Howard-Thompson (2018) Am Fam Physician 97(1):29-37
  2. Inzucchi (2015) Diabetes Care 38(1): 140-9 [PubMed]

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Ontology: Insulin (C0021641)

Definition (NCI) A short-acting form of insulin. Regular insulin is obtained from animal or recombinant sources. The onset of action of regular insulin occurs at 30-90 minutes after injection; its effect lasts for 6 to 8 hours. Endogenous human insulin, a pancreatic hormone composed of two polypeptide chains, is important for the normal metabolism of carbohydrates, proteins and fats; it has anabolic effects on many types of tissues. (NCI04)
Definition (NCI) Insulin (51 aa, ~6 kDa) is encoded by the human INS gene. This protein is involved in the direct regulation of glucose metabolism.
Definition (CSP) protein hormone secreted by beta cells of the pancreas; insulin plays a major role in the regulation of glucose metabolism, generally promoting the cellular utilization of glucose and is also an important regulator of protein and lipid metabolism; insulin is used as a drug to control insulin-dependent diabetes mellitus.
Definition (MSH) A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).
Concepts Pharmacologic Substance (T121) , Amino Acid, Peptide, or Protein (T116) , Hormone (T125)
MSH D007328
SnomedCT 325014006, 67866001, 39487003, 412222002
LNC LP70329-5, LP16325-0, LP14676-8, LP32542-0, MTHU002108, MTHU019392, LA15805-7
English Insulin, insulin, Regular Insulin, Soluble insulin, Insulin Regular, insulin preparations, insulin preparations (medication), insulin regular, Insulin [Chemical/Ingredient], insulin products, insulin preparation, insulin product, regular insulin, insulins, Insulin, Soluble, Soluble Insulin, Soluble insulin (substance), Insulin regular, Insulin, Regular, Insulin product, Insulin (substance), Insulin preparation, Insulin product (product), Regular insulin product, Unmodified insulin product, Insulin preparation, NOS, Regular insulin preparation, Unmodified insulin preparation, Insulin preparation (substance), Regular insulin (substance), Regular insulin, INSULIN
Swedish Insulin
Finnish Insuliini
French Insuline ordinaire, Insuline soluble, Insuline
Russian INSULIN, ИНСУЛИН
Spanish producto con insulina (producto), preparado insulínico, insulina (producto), producto con insulina, insulina (sustancia), insulina, preparado de insulina (producto), preparado de insulina (sustancia), preparado de insulina cristalina de cinc, preparado de insulina cristalina de zinc, preparado de insulina no modificada, preparado de insulina, insulina regular (sustancia), insulina regular, Insulina
Italian Insulina regolare, Insulina
Croatian INZULIN
Polish Insulina
Japanese インスリン, インスリン亜鉛水性懸濁液, インシュリン
Czech inzulin, insulin
Norwegian Insulin, Oppløselig insulin
German Insulin
Portuguese Insulina