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Insulin Therapy in the Hospital Comparing Two Protocols

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT00841919
First received: February 9, 2009
Last updated: September 8, 2009
Last verified: September 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Nursing staff satisfaction scores for evaluation of the two methods [ Time Frame: 24 hours after last patient is discharged ] [ Designated as safety issue: No ]
  • Hypoglycemia rates. [ Time Frame: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by John H. Stroger Hospital

Additional 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
Study First Received: February 9, 2009
Last Updated: September 8, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014