Prandial Insulin Dosing in Hospitalized Patients

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Kathleen Dungan
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Long-Acting

Criteria

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