Insulin Therapy in the Hospital Comparing Two Protocols

NCT ID: NCT00841919

Last Updated: 2009-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-06-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

NPH insulin and regular insulin

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Glargine insulin

Intervention Type: DRUG

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.

lispro insulin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lantus insulin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Cook County Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

John H. Stroger Jr. Hospital of Cook County

Principal Investigators

Leon Fogelfeld, MD

Role: PRINCIPAL_INVESTIGATOR

John H Stroger Jr. Hospital

Evelyn Lacuesta, MD

Role: STUDY_CHAIR

John H Stroger Jr. Hospital

Yannis Guerra, MD

Role: STUDY_CHAIR

Rush University Hospital

Locations

John H Stroger Jr. Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21454236 (View on PubMed)

Other Identifiers

BBJHS200901

Identifier Type: -

Identifier Source: org_study_id