Prandial Insulin Dosing in Hospitalized Patients (ICHO)

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01101867
First received: April 8, 2010
Last updated: July 2, 2013
Last verified: July 2013

April 8, 2010
July 2, 2013
June 2010
June 2012   (final data collection date for primary outcome measure)
Mean Glucose [ Time Frame: day 3 ] [ Designated as safety issue: No ]
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
Mean glucose [ Time Frame: day 3 ] [ Designated as safety issue: No ]
mean 7-point glucose at day 3
Complete list of historical versions of study NCT01101867 on ClinicalTrials.gov Archive Site
  • Postprandial Glucose [ Time Frame: day 3 ] [ Designated as safety issue: No ]
    Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.
  • Hypoglycemia [ Time Frame: 72 hour ] [ Designated as safety issue: Yes ]
    Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)
  • Rate of Change in Glucose [ Time Frame: 72 hour ] [ Designated as safety issue: No ]
  • Treatment Satisfaction [ Time Frame: day 3 ] [ Designated as safety issue: No ]
    treatment satisfaction questionnaire validated in-hospital
  • 1,5-anhydroglucitol Change [ Time Frame: day 1 to day 3 ] [ Designated as safety issue: No ]
    change in short-term measure of glycemia
  • postprandial glucose [ Time Frame: day 3 ] [ Designated as safety issue: No ]
    mean of day 3 post-breakfast, lunch and dinner glucose
  • hypoglycemia [ Time Frame: 72 hour ] [ Designated as safety issue: Yes ]
    number of hypoglycemic events (<70 mg/dl or <40 mg/dl)
  • rate of change in glucose [ Time Frame: 72 hour ] [ Designated as safety issue: No ]
  • treatment satisfaction [ Time Frame: day 3 ] [ Designated as safety issue: No ]
    treatment satisfaction questionnaire validated in-hospital
  • 1,5-anhydroglucitol change [ Time Frame: day 1 to day 3 ] [ Designated as safety issue: No ]
    change in short-term measure of glycemia
Not Provided
Not Provided
 
Prandial Insulin Dosing in Hospitalized Patients
Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Admitting Hospital
  • Non-critically Ill
  • Drug: Aspart
    fixed dose
    Other Name: Novolog
  • Drug: Aspart
    dose based upon carbohydrate intake and total daily requirements
    Other Name: Novolog
  • Experimental: flexible dose
    aspart dose determined based upon carbohydrate intake.
    Intervention: Drug: Aspart
  • Active Comparator: fixed dose
    fixed meal dose of aspart (based upon weight or total daily insulin dose)
    Intervention: Drug: Aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
March 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01101867
Novo Nordisk xxxx
No
Kathleen Dungan, The Ohio State University
Kathleen Dungan
Novo Nordisk A/S
Principal Investigator: Kathleen M Dungan, MD Ohio State University
Ohio State University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP