Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes

Emory University226 enrolled

Overview

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.

The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

226

Conditions

Interventions

Insulin glargineDRUG

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%.

Insulin aspartDRUG

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%.

Supplemental insulin aspartDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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