Insulin Therapy in the Hospital Comparing Two Protocols

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: NPH insulin and regular insulin; Drug: Glargine insulin; Drug: lispro insulin

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H Stroger Jr. Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2; 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.	Drug: 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.
Experimental: 1; 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	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.; Other Names: Lantus insulin; Drug: 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.

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• Sponsor: John H. Stroger Hospital
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Leon Fogelfeld, MD, John H Stroger Jr. Hospital; Study Chair: Evelyn Lacuesta, MD, John H Stroger Jr. Hospital; Study Chair: Yannis Guerra, MD, Rush University Hospital

Publications and helpful links

General Publications

• Guerra YS, Lacuesta EA, Yrastorza R, Miernik J, Shakya N, Fogelfeld L. Insulin injections in relation to meals in the hospital medicine ward: comparison of 2 protocols. Endocr Pract. 2011 Sep-Oct;17(5):737-46. doi: 10.4158/EP10358.OR.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 11, 2009
• First Posted (Estimate): February 12, 2009

Study Record Updates

• Last Update Posted (Estimate): September 9, 2009
• Last Update Submitted That Met QC Criteria: September 8, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Diabetes; Insulin; Inpatient; Insulin pen
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: BBJHS200901