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

• Status: Completed
• Trial end date: 2019-12-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting

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