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Insulin Therapy in the Hospital Comparing Two Protocols

Information source: John H. Stroger Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Glargine insulin (Drug); NPH insulin and regular insulin (Drug); lispro insulin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: John H. Stroger Hospital

Official(s) and/or principal investigator(s):
Leon Fogelfeld, MD, Principal Investigator, Affiliation: John H Stroger Jr. Hospital
Evelyn Lacuesta, MD, Study Chair, Affiliation: John H Stroger Jr. Hospital
Yannis Guerra, MD, Study Chair, Affiliation: Rush University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The rate of correct timing of insulin and food administration

Pre and post- prandial glucose levels

Secondary outcome:

Length of hospital stay

Nursing staff satisfaction scores for evaluation of the two methods

Hypoglycemia rates.

High excursions of blood sugars (>300 mg/dl).

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

John H Stroger Jr. Hospital, Chicago, Illinois 60612, United States
Additional Information

Starting date: December 2006
Last updated: September 8, 2009

Page last updated: August 23, 2015

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