Insulin Therapy in the Hospital Comparing Two Protocols

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841919
• Other study ID #: BBJHS200901
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2009
• Last updated: September 8, 2009
• Start date: December 2006
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• Source: John H. Stroger Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Glargine insulin
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.
• NPH insulin and regular insulin
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.
• lispro insulin
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.

Locations

Country	Name	City	State
United States	John H Stroger Jr. Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
John H. Stroger Hospital	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of hospital stay		Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
Secondary	Nursing staff satisfaction scores for evaluation of the two methods		24 hours after last patient is discharged
Secondary	Hypoglycemia rates.		From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
Secondary	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