Prandial Insulin Dosing in Hospitalized Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01101867
• Date of registration: 08/04/2010
• Primary sponsor: Kathleen Dungan
• Public title: Prandial Insulin Dosing in Hospitalized Patients ICHO
• Scientific title: Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes
• Date of first enrolment: June 2010
• Target sample size: 110
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01101867
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Kathleen M Dungan, MD
• Affiliation: Ohio State University

Key inclusion & exclusion criteria

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, TPN, or tube feeds.

- Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on
pharmacologic contraceptives, 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 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Admitting Hospital

Diabetes

Non-critically Ill

Intervention(s)

Drug: Aspart

Primary Outcome(s)

Mean glucose [Time Frame: day 3]

Secondary Outcome(s)

1,5-anhydroglucitol change [Time Frame: day 1 to day 3]

hypoglycemia [Time Frame: 72 hour]

postprandial glucose [Time Frame: day 3]

rate of change in glucose [Time Frame: 72 hour]

treatment satisfaction [Time Frame: day 3]

Secondary ID(s)

Novo Nordisk xxxx

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novo Nordisk