Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01184014
• Date of registration: 16/08/2010
• Primary sponsor: Park Nicollet Institute
• Public title: Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
• Scientific title: Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
• Date of first enrolment: August 2010
• Target sample size: 144
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01184014
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Mary L Johnson, RN

• Name: Kathy McCann, RN

• Name: Richard M Bergenstal, MD
• Affiliation: International Diabetes Center at Park Nicollet

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men or women aged =18 years who receive steroids in doses greater than physiologic
replacement levels of = 10 mg Prednisone or its equivalent of dexamethasone or
methylprednisolone.

- Have signed the consent form for the study

- Have a BG > 180 mg/dL any time during the first 24 hour of steroid administration
that is above physiological replacement ( = 10 mg Prednisone or equivalent)

- Are scheduled to be in hospital = 2 days.

Exclusion Criteria:

- Unable to read or understand English

- History of psychiatric disability affecting informed consent or compliance with drug
intake

- Type 1 diabetes

- Acute or chronic renal failure (creatinine clearance <30mL/min estimated by method of
Cockcroft and Gault)

- Patients in Hospice Care

- Age <18 years

- Previously enrolled in this study.

- Not appropriate for the steroid protocol in judgment of the principal investigator
and/or attending physician.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hyperglycemia

Intervention(s)

Drug: Complete Insulin Orders

Drug: NPH insulin plus Complete Insulin Orders

Primary Outcome(s)

the proportion of blood glucose readings between 70 and 180 mg/dL, inclusive [Time Frame: discharge or until after their 5th day in the hospital]

Secondary Outcome(s)

the mean blood glucose of all blood glucose readings [Time Frame: starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days]

Secondary ID(s)

04000-10-C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Diabetes Center at Park Nicollet

Sanofi-Aventis