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

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Heart & Vascular Institute
• Collaborators: LifeScan; Sanofi

Criteria

Inclusion Criteria:

• Patients 18 - 80 years old

• Pre-op diagnosis of diabetes

• Scheduled for elective or urgent CABG surgery

• Able to sign informed consent for research study

Exclusion Criteria:

• Patients less than 18 years old or greater than 80 years old

• Emergent or salvage CABG surgery

• Other surgical intervention planned in same setting ( Valve surgery, TMR, MAZE...)