Insulin Therapy in the Hospital Comparing Two Protocols

Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study

Sponsors

Lead Sponsor: John H. Stroger Hospital

Collaborator: Eli Lilly and Company

Source John H. Stroger Hospital
Brief Summary

The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.

Overall Status Completed
Start Date December 2006
Completion Date June 2009
Primary Completion Date March 2009
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
The rate of correct timing of insulin and food administration Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
Pre and post- prandial glucose levels Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
Secondary Outcome
Measure Time Frame
Length of hospital stay Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
Nursing staff satisfaction scores for evaluation of the two methods 24 hours after last patient is discharged
Hypoglycemia rates. From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
High excursions of blood sugars (>300 mg/dl). From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Glargine insulin

Description: The study group will receive Insulin Glargine as basal insulin. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.

Arm Group Label: 1

Other Name: Lantus insulin

Intervention Type: Drug

Intervention Name: NPH insulin and regular insulin

Description: The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.

Arm Group Label: 2

Intervention Type: Drug

Intervention Name: lispro insulin

Description: Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.

Arm Group Label: 1

Eligibility

Criteria:

Inclusion Criteria:

- Uncontrolled blood sugar:

- Random blood sugar ≥ 200mg/dl

- Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours.

- Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.

- Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.

- Patient is able to eat and oral feeding is expected.

Exclusion Criteria:

- Patients receiving inpatient oral hypoglycemic agents

- Patients with chronic kidney disease stages 4 & 5 (estimated GFR of <30ml/min) and on dialysis

- Patient with chronic liver disease

- Patient with hypoglycemia unawareness

- Pregnancy

- Patients who are on "NPO" for medical reasons.

- Patient is expected to stay in the hospital for less than 3 days.

- Patient on a new inpatient insulin regimen for > 36 hours.

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Location
Facility: John H Stroger Jr. Hospital
Location Countries

United States

Verification Date

September 2009

Responsible Party

Name Title: Leon Fogelfeld

Organization: John H. Stroger Jr. Hospital of Cook County

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 2

Type: Active Comparator

Description: The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.

Label: 1

Type: Experimental

Description: The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov