Insulin Therapy in the Hospital Comparing Two Protocols

NCT00841919 | Completed Phase 4

• 1 other identifier: BBJHS200901
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Diabetes; Inpatient; Insulin; Insulin pen

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

2

ACTIVE COMPARATOR

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

1

EXPERIMENTAL

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; Drug: lispro insulin

Interventions

Glargine insulin 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.

Also known as: Lantus insulin

1

NPH insulin and regular insulin 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.

2

lispro insulin 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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook County Health: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

John H Stroger Jr. Hospital

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 21454236 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Glargine; Insulin, Isophane; Insulin; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin; Insulin, Short-Acting

Study Officials

• Leon Fogelfeld, MD

  John H Stroger Jr. Hospital

  PRINCIPAL INVESTIGATOR

• Evelyn Lacuesta, MD

  John H Stroger Jr. Hospital

  STUDY CHAIR

• Yannis Guerra, MD

  Rush University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 12, 2009
• Study Start: December 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 9, 2009

Record last verified: 2009-09

Locations

US (1)