Prandial Insulin Dosing in Hospitalized Patients

Diabetes Clinical Trial

— ICHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101867
• Other study ID #: Novo Nordisk xxxx
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2010
• Last updated: January 3, 2018
• Start date: June 2010
• Est. completion date: March 2013

Study information

• Verified date: January 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Admitting Hospital
• Diabetes
• Non-critically Ill

Intervention

Drug:
• Aspart fixed dose
fixed dose
• Aspart flexible dose
dose based upon carbohydrate intake and total daily requirements

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kathleen Dungan	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Glucose	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	Postprandial Glucose	Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.	day 3
Secondary	Hypoglycemia	Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)	72 hour
Secondary	Change in Glucose	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
Secondary	Treatment Satisfaction	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
Secondary	1,5-anhydroglucitol Change	change in short-term measure of glycemia	day 1 to day 3