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
  Purpose

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.


Condition Intervention Phase
Diabetes
Admitting Hospital
Non-critically Ill
Drug: Aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 126
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: flexible dose
aspart dose determined based upon carbohydrate intake.
Drug: Aspart
dose based upon carbohydrate intake and total daily requirements
Other Name: Novolog
Active Comparator: fixed dose
fixed meal dose of aspart (based upon weight or total daily insulin dose)
Drug: Aspart
fixed dose
Other Name: Novolog

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101867

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Kathleen Dungan
Novo Nordisk A/S
Investigators
Principal Investigator: Kathleen M Dungan, MD Ohio State University
  More Information

No publications provided

Responsible Party: Kathleen Dungan, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01101867     History of Changes
Other Study ID Numbers: Novo Nordisk xxxx
Study First Received: April 8, 2010
Results First Received: April 9, 2013
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University:
diabetes
glucose
hospital

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014