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



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:2/2/2019
Start Date:October 2015
End Date:December 2019
Contact:Priyathama Vellanki, MD
Email:priyathama.vellanki@emory.edu
Phone:(404) 778 1687

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Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen

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.

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
We found this trial at
2
sites
80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Phone: 404-778-1687
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Atlanta, GA
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Phone: 404-778-1687
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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