Clinical trial NCT00841919: Insulin Therapy in the Hospital Comparing Two Protocols
Official title: Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Inpatient
Insulin
Insulin pen
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
Collaborators: name: Eli Lilly and Company
First posted: 2009-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The rate of correct timing of insulin and food administration
timeFrame: 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
measure: Pre and post- prandial glucose levels
timeFrame: 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:
measure: Length of hospital stay
timeFrame: Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
measure: Nursing staff satisfaction scores for evaluation of the two methods
timeFrame: 24 hours after last patient is discharged
measure: Hypoglycemia rates.
timeFrame: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
measure: High excursions of blood sugars (>300 mg/dl).
timeFrame: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H Stroger Jr. Hospital
state: Illinois
Study officials:
affiliation: John H Stroger Jr. Hospital
name: Leon Fogelfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: John H Stroger Jr. Hospital
name: Evelyn Lacuesta, MD
role: STUDY_CHAIR
affiliation: Rush University Hospital
name: Yannis Guerra, MD
role: STUDY_CHAIR
References:
citation: 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.