Prandial Insulin Dosing in Hospitalized Patients (ICHO)
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|ClinicalTrials.gov Identifier: NCT01101867|
Recruitment Status : Completed
First Posted : April 12, 2010
Results First Posted : July 2, 2013
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Admitting Hospital Non-critically Ill||Drug: Aspart fixed dose Drug: Aspart flexible dose||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||March 2013|
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 Name: Novolog
Active Comparator: Aspart fixed dose
fixed meal dose of aspart (based upon weight or total daily insulin dose)
Drug: Aspart fixed dose
Other Name: Novolog
- 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
- 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)
- 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.
- 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.
- 1,5-anhydroglucitol Change [ Time Frame: day 1 to day 3 ]change in short-term measure of glycemia
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
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Kathleen M Dungan, MD||Ohio State University|