Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: Insulin glargine; Insulin aspart; Supplemental insulin aspart
Intervention description: Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day.
Daily insulin dose will be adjusted as follow:
If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change
If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day
If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day
If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day
If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.; Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held.
Daily insulin dose will be adjusted as follow:
If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change
If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day
If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day
If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day
If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.; Insulin aspart will be administered following the supplemental insulin scale protocol.
For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows:
BG >141-180 mg/dL; 2-4 units of insulin aspart
BG between 181-220 mg/dL; 3-6 units of insulin aspart
BG between 221-260 mg/dL; 4-8 units of insulin aspart
BG between 261-300 mg/dL; 5-10 units of insulin aspart
BG between 301-350 mg/dL; 6-12 units of insulin aspart
BG between 351-400 mg/dL; 7-14 units of insulin aspart
BG > 400 mg/dL; 8-16 units of insulin aspart
For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:
BG between 261-300 mg/dL; 5-10 units of insulin aspart
BG between 301-350 mg/dL; 6-12 units of insulin aspart
BG between 351-400 mg/dL; 7-14 units of insulin aspart
BG > 400 mg/dL; 8-16 units of insulin aspart
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hyperglycemia; Hypoglycemia

Summary:

      The purpose of this study is to test whether using extra doses of aspart insulin to correct
      blood sugars before meals improves the care of patients with type 2 diabetes in the hospital
      who are already receiving the standard of care treatment with glargine and aspart insulin
      injections to control blood sugar levels. Studies done in the past indicate that blood sugar
      levels are controlled on the standard treatment of insulin and that most patients do not need
      the small extra dose of insulin at bedtime. The investigators want to test if there is any
      benefit to giving patients extra doses of insulin during the day to correct the high blood
      sugars.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects admitted to the hospital with acute or chronic medical illnesses or for
             elective and emergency surgical illness or trauma

          2. Known history of Type 2 diabetes mellitus for >3 months

          3. Treated with either diet alone, any combination of oral antidiabetic agents,
             non-insulin injectables or insulin therapy

          4. Blood glucose levels between >140 mg and <400 mg/dL without laboratory evidence of
             diabetic ketoacidosis

        Exclusion Criteria:

          1. Hyperglycemia without a history of diabetes

          2. Subjects with acute critical illness admitted to the ICU or expected to require ICU
             admission

          3. Subjects receiving continuous insulin infusion

          4. Clinically relevant hepatic disease

          5. Corticosteroid therapy

          6. Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) <30

          7. Subjects unable to sign consent

          8. Pregnancy