Prandial Insulin Dosing in Hospitalized Patients (ICHO)

Kathleen Dungan

Status and phase: Completed; Phase 4

Conditions: Diabetes; Admitting Hospital; Non-critically Ill

Treatments: Drug: Aspart flexible dose; Drug: Aspart fixed dose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01101867

Novo Nordisk xxxx

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Aspart flexible dose

Experimental group

Description:

aspart dose determined based upon carbohydrate intake.

Treatment:

Drug: Aspart flexible dose

Aspart fixed dose

Active Comparator group

Description:

fixed meal dose of aspart (based upon weight or total daily insulin dose)

Treatment:

Drug: Aspart fixed dose