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OpenTrials
Completed

NCT Number: NCT01101867

Prandial Insulin Dosing in Hospitalized Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspart fixed dose

Drug

fixed dose

Other names: Novolog

Aspart flexible dose

Drug

dose based upon carbohydrate intake and total daily requirements

Other names: Novolog

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Hypoglycemia

    Time frame: 72 hour

    Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)

  3. 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.

  4. 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.

  5. 1,5-anhydroglucitol Change

    Time frame: day 1 to day 3

    change in short-term measure of glycemia

Sponsors and collaborators

Lead sponsor

Kathleen Dungan

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes

Acronym: ICHO

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Apr 12, 2010
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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