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United States Coronary Artery Bypass Surgery (CABG) Diabetes Project (USCDP) Pilot Study

NCT00646438 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-02-04

No results posted yet for this study

Summary

Standard care for patients with diabetes having CABG surgery at Providence St. Vincent Medical Center includes strict control of blood sugar (glucose) levels for 3 days after surgery. This is done through frequent monitoring of blood sugar levels and by giving insulin continuously through a needle into a vein (intravenously). This intensive glucose control has resulted in fewer complications such as serious infections and death, and has shortened the length of the hospital stay for patients.

This study treatment is different from standard treatment in that it extends the intensive glucose control beyond the third postoperative day to one full year. Once discharged from the hospital following the CABG procedure, the intense glucose control is done using subcutaneous insulin (a shot under the skin), oral medications, and by measuring blood sugar levels frequently.

The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year. Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.

Conditions

Interventions

DRUG

Strict Glycemic Control for one year post-op CABG

The CDE and Study Coordinator will also meet with the patient in the hospital to show how the Lifescan One-Touch Ultra II glucometer works and review the study follow-up schedule. Patients will be sent home with the Lifescan One-Touch Ultra II glucometer and a supply of strips. Post-Discharge Period Patients will meet alternatively with the CDE and study doctor on a specific schedule including every week for the first month, every 2 weeks in the second month, and every month thereafter till the 12th month. During these sessions the BG records will be downloaded from the Lifescan One-Touch Ultra II glucometer and reviewed to see patterns and any areas that could be improved or changed. For all patients in the study arm, the medications that are being taken and the results of glucose monitoring charts will be reviewed weekly with endocrinologists so that any additional recommendations may be made to improve glucose control.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • LifeScan

    collaborator INDUSTRY

  • Providence Heart & Vascular Institute

    lead OTHER

Principal Investigators

  • Anthony Furnary, MD · Providence Heart & Vascular Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-02-29
Completion
2012-12-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00646438 on ClinicalTrials.gov