Prandial Insulin Dosing in Hospitalized Patients (ICHO)
This study has been completed.
Novo Nordisk A/S
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
First received: April 8, 2010
Last updated: July 2, 2013
Last verified: July 2013
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes
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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
Experimental: flexible dose
aspart dose determined based upon carbohydrate intake.
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)
Other Name: Novolog
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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
• 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01101867
|The Ohio State University
|Columbus, Ohio, United States, 43210 |
Novo Nordisk A/S
||Kathleen M Dungan, MD
||Ohio State University
No publications provided
||Kathleen Dungan, Assistant Professor, The Ohio State University
History of Changes
|Other Study ID Numbers:
||Novo Nordisk xxxx
|Study First Received:
||April 8, 2010
|Results First Received:
||April 9, 2013
||July 2, 2013
||United States: Food and Drug Administration
Keywords provided by Ohio State University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs