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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014