Prandial Insulin Dosing in Hospitalized Patients (ICHO)

January 3, 2018 updated by: Kathleen Dungan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspart flexible dose
aspart dose determined based upon carbohydrate intake.
Drug: Aspart flexible dose
dose based upon carbohydrate intake and total daily requirements
Other Names:
  • Novolog
Active Comparator: Aspart fixed dose
fixed meal dose of aspart (based upon weight or total daily insulin dose)
Drug: Aspart fixed dose
fixed dose
Other Names:
  • Novolog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 3
Hypoglycemia
Time Frame: 72 hour
Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)
72 hour
Change in Glucose
Time Frame: 72 hour
Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.
72 hour
Treatment Satisfaction
Time Frame: day 3
treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.
day 3
1,5-anhydroglucitol Change
Time Frame: day 1 to day 3
change in short-term measure of glycemia
day 1 to day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathleen Dungan

Collaborators

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Novo Nordisk xxxx

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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