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Insulin Therapy in the Hospital Comparing Two Protocols

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glargine insulin
NPH insulin and regular insulin
lispro insulin
Sponsored by
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Inpatient, Insulin, Insulin pen

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • John H Stroger Jr. Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm 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.

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

Outcomes

Primary Outcome Measures

The rate of correct timing of insulin and food administration
Pre and post- prandial glucose levels

Secondary Outcome Measures

Length of hospital stay
Nursing staff satisfaction scores for evaluation of the two methods
Hypoglycemia rates.
High excursions of blood sugars (>300 mg/dl).

Full Information

First Posted
February 9, 2009
Last Updated
September 8, 2009
Sponsor
Cook County Health
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00841919
Brief Title
Insulin Therapy in the Hospital Comparing Two Protocols
Official Title
Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cook County Health
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, Inpatient, Insulin, Insulin pen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm 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 Title
1
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Glargine insulin
Other Intervention Name(s)
Lantus insulin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
NPH insulin and regular insulin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
lispro insulin
Intervention 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.
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
Length of hospital stay
Time Frame
Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
Title
Nursing staff satisfaction scores for evaluation of the two methods
Time Frame
24 hours after last patient is discharged
Title
Hypoglycemia rates.
Time Frame
From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Fogelfeld, MD
Organizational Affiliation
John H Stroger Jr. Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evelyn Lacuesta, MD
Organizational Affiliation
John H Stroger Jr. Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yannis Guerra, MD
Organizational Affiliation
Rush University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
John H Stroger Jr. Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21454236
Citation
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.
Results Reference
derived

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Insulin Therapy in the Hospital Comparing Two Protocols

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