Prandial Insulin Dosing in Hospitalized Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Detailed Description
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The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Official Title
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Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes

Conditions
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Diabetes, Admitting Hospital, Non-critically Ill

Intervention / Treatment
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* Drug: Aspart fixed dose
* Drug: Aspart flexible dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: general medical or minor surgical hospitalized patients type 2 diabetes blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment Exclusion Criteria: • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours). Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds. Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing. Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely Prolonged (>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable. Patients for whom expected length of stay will be less than 48 hours Patients using subcutaneous insulin pumps Diabetic ketoacidosis End-stage renal disease on dialysis End-stage liver disease with cirrhosis Mental conditions precluding informed consent Potentially sensitive admissions: prisoners, HIV, suicidality Unable to give consent in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspart flexible dose<br>aspart dose determined based upon carbohydrate intake. | Drug: Aspart flexible dose<br>* dose based upon carbohydrate intake and total daily requirements<br>* Other names: Novolog;|
| Active Comparator: Aspart fixed dose<br>fixed meal dose of aspart (based upon weight or total daily insulin dose) | Drug: Aspart fixed dose<br>* fixed dose<br>* Other names: Novolog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Glucose | Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3 | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glucose | Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3. | day 3 | 
| Hypoglycemia | Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl) | 72 hour | 
| Change in Glucose | Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1. | 72 hour | 
| Treatment Satisfaction | treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score. | day 3 | 
| 1,5-anhydroglucitol Change | change in short-term measure of glycemia | day 1 to day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, glucose, hospital