We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Insulin Therapy in the Hospital Comparing Two Protocols

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00841919
First Posted: February 12, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by:
John H. Stroger Hospital
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: Glargine insulin Drug: NPH insulin and regular insulin Drug: lispro insulin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study

Resource links provided by NLM:


Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • The rate of correct timing of insulin and food administration [ Time Frame: 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 [ Time Frame: 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:
  • Length of hospital stay [ Time Frame: 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 [ Time Frame: 24 hours after last patient is discharged ]
  • Hypoglycemia rates. [ Time Frame: 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). [ Time Frame: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial ]

Estimated Enrollment: 60
Study Start Date: December 2006
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841919


Locations
United States, Illinois
John H Stroger Jr. Hospital
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leon Fogelfeld, John H. Stroger Jr. Hospital of Cook County
ClinicalTrials.gov Identifier: NCT00841919     History of Changes
Other Study ID Numbers: BBJHS200901
First Submitted: February 9, 2009
First Posted: February 12, 2009
Last Update Posted: October 12, 2017
Last Verified: September 2009

Keywords provided by John H. Stroger Hospital:
Diabetes
Inpatient
Insulin
Insulin pen

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Glargine
Insulin Lispro
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs