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Completed

NCT Number: NCT00841919

Insulin Therapy in the Hospital Comparing Two Protocols

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

John H Stroger Jr. Hospital

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Lantus insulin

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.

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.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Length of hospital stay

    Time frame: Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge

  2. Nursing staff satisfaction scores for evaluation of the two methods

    Time frame: 24 hours after last patient is discharged

  3. Hypoglycemia rates.

    Time frame: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial

  4. 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

Sponsors and collaborators

Lead sponsor

Cook County Health

Other Gov

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 12, 2009
Registry last updated
Sep 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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