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Prandial Insulin Dosing in Hospitalized Patients (ICHO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101867
First Posted: April 12, 2010
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Kathleen Dungan, The Ohio State University:

Primary Outcome Measures:
  • Mean Glucose [ Time Frame: day 3 ]
    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 ]
    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 ]
    Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)

  • Rate of Change in Glucose [ Time Frame: 72 hour ]
  • Treatment Satisfaction [ Time Frame: day 3 ]
    treatment satisfaction questionnaire validated in-hospital

  • 1,5-anhydroglucitol Change [ Time Frame: day 1 to day 3 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kathleen Dungan, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01101867     History of Changes
Other Study ID Numbers: Novo Nordisk xxxx
First Submitted: April 8, 2010
First Posted: April 12, 2010
Results First Submitted: April 9, 2013
Results First Posted: July 2, 2013
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by Kathleen Dungan, The Ohio State University:
diabetes
glucose
hospital

Additional relevant MeSH terms:
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs