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 administrationPre and post- prandial glucose levels
Secondary outcome: Length of hospital stayNursing 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
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