Trial Outcomes & Findings for Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients (NCT NCT01792830)

Last Updated: 2018-09-24

Results Overview

Change in the level of HbA1c in a one month period after discharge from the hospital. The A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

175 participants

Primary outcome timeframe

One month after hospital discharge

Results posted on

2018-09-24

Participant Flow

Participants were recruited from Emory University Hospital, Emory University Hospital - Midtown, and Grady Memorial Hospital, in Atlanta, Georgia, from October 2012 to February 2014. Study arms for results are presented to precisely reflect the medication used post-hospital discharge, as prescribed by the participant's provider.

Participant milestones

Participant milestones
Measure	Control, Non-diabetic, no Treatment Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Metformin and Insulin Glargine Participants with a history of diabetes and with HbA1C \<7% who were discharged on metformin and insulin glargine, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
Overall Study STARTED	84	3	4	21	2	4	14	7	20	4	12
Overall Study COMPLETED	59	3	4	18	1	3	12	6	11	4	9
Overall Study NOT COMPLETED	25	0	0	3	1	1	2	1	9	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Control, Non-diabetic, no Treatment Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Diabetic, HbA1C <7%, Metformin Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Metformin and Insulin Glargine Participants with a history of diabetes and with HbA1C \<7% who were discharged on metformin and insulin glargine, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
Overall Study Withdrawal by Subject	22	2	1	1	1	1	7	2
Overall Study Death	3	1	0	0	1	0	1	1
Overall Study Adverse Event	0	0	0	0	0	0	1	0

Baseline Characteristics

Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control, Non-diabetic, no Treatment n=84 Participants Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin n=3 Participants Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin n=4 Participants Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin n=21 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Metformin and Insulin Glargine n=2 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on metformin and insulin glargine, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine n=4 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin n=14 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine n=7 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine n=20 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine n=4 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine n=12 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.	Total n=175 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	11 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	5 Participants n=3 Participants	2 Participants n=6 Participants	8 Participants n=114 Participants	4 Participants	11 Participants n=19 Participants	84 Participants n=4 Participants
Age, Categorical >=65 years	43 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	10 Participants n=7 Participants	2 Participants n=31 Participants	3 Participants n=30 Participants	9 Participants n=3 Participants	5 Participants n=6 Participants	12 Participants n=114 Participants	0 Participants	1 Participants n=19 Participants	91 Participants n=4 Participants
Sex: Female, Male Female	23 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	6 Participants n=7 Participants	1 Participants n=31 Participants	1 Participants n=30 Participants	5 Participants n=3 Participants	1 Participants n=6 Participants	5 Participants n=114 Participants	3 Participants	3 Participants n=19 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	61 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	15 Participants n=7 Participants	1 Participants n=31 Participants	3 Participants n=30 Participants	9 Participants n=3 Participants	6 Participants n=6 Participants	15 Participants n=114 Participants	1 Participants	9 Participants n=19 Participants	126 Participants n=4 Participants
Region of Enrollment United States	84 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants	21 Participants n=7 Participants	2 Participants n=31 Participants	4 Participants n=30 Participants	14 Participants n=3 Participants	7 Participants n=6 Participants	20 Participants n=114 Participants	4 Participants	12 Participants n=19 Participants	175 Participants n=4 Participants

PRIMARY outcome

Timeframe: One month after hospital discharge

Population: This analysis includes participants who had blood drawn one month after hospital discharge. Most patients that completed the discharge part did so over the phone. The "diabetic, HbA1C \<7%, metformin and insulin glargine" is not included in this table as no participants in this group had blood drawn for this analysis.

Outcome measures

Outcome measures
Measure	Control, Non-diabetic, no Treatment n=24 Participants Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin n=1 Participants Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin n=2 Participants Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin n=9 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine n=3 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin n=6 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine n=4 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine n=9 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine n=3 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine n=5 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.	Diabetic, HbA1C >9%, Insulin Glulisine Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
Efficacy, Measured by a Change in HbA1c Levels	5.09 percent of glycosylated hemoglobin Standard Deviation 0.43	5.2 percent of glycosylated hemoglobin Standard Deviation 0.00	5.5 percent of glycosylated hemoglobin Standard Deviation 0.5	5.8 percent of glycosylated hemoglobin Standard Deviation 0.5	6.9 percent of glycosylated hemoglobin Standard Deviation 1.60	6.1 percent of glycosylated hemoglobin Standard Deviation 2.60	6.3 percent of glycosylated hemoglobin Standard Deviation 0.89	6.6 percent of glycosylated hemoglobin Standard Deviation 0.70	8.6 percent of glycosylated hemoglobin Standard Deviation 1.9	6.9 percent of glycosylated hemoglobin Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: 3 months after discharge

Population: This analysis includes participants who completed the month 3 study visit either in person or by phone.

The number of participants that were readmitted to the hospital 3 months after initial hospital discharge

Outcome measures

Outcome measures
Measure	Control, Non-diabetic, no Treatment n=41 Participants Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin n=2 Participants Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin n=4 Participants Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin n=3 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine n=1 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin n=1 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine n=6 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine n=5 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine n=8 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine n=3 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.	Diabetic, HbA1C >9%, Insulin Glulisine n=4 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
Number of Participants Readmitted to the Hospital	11 participants	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 3 months after discharge

Population: This analysis includes participants who completed the month 3 study visit either in person or by phone.

The number of participants that experienced hypoglycemia, defined as blood glucose levels ≤70 mg/dl.

Outcome measures

Outcome measures
Measure	Control, Non-diabetic, no Treatment n=41 Participants Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin n=2 Participants Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin n=4 Participants Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin n=3 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine n=1 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin n=1 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine n=6 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine n=5 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine n=8 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine n=3 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.	Diabetic, HbA1C >9%, Insulin Glulisine n=4 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
The Number of Participants Experiencing a Hypoglycemic Event	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months after discharge

Population: Participants who completed the Month 3 study visit in person or by phone.

The number of participants that experienced severe hypoglycemia, defined as blood glucose levels ≤ 40 mg/dl.

Outcome measures

Outcome measures
Measure	Control, Non-diabetic, no Treatment n=41 Participants Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin n=2 Participants Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin n=4 Participants Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin n=3 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine n=1 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin n=1 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine n=6 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine n=5 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine n=8 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine n=3 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.	Diabetic, HbA1C >9%, Insulin Glulisine n=4 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
The Number of Participants Experiencing a Severe Hypoglycemic Event	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months after discharge

Population: Participants who completed the Month 3 study visit, in person or by phone.

The number of participants that experienced hyperglycemia, defined as blood glucose levels ≥ 140 mg/dl.

Outcome measures

Outcome measures
Measure	Control, Non-diabetic, no Treatment n=41 Participants Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin n=2 Participants Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin n=4 Participants Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin n=3 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine n=1 Participants Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin n=1 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine n=6 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine n=5 Participants Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine n=8 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine n=3 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.	Diabetic, HbA1C >9%, Insulin Glulisine n=4 Participants Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
Number of Participants Experiencing a Hyperglycemic Event	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	3 Participants	1 Participants	3 Participants	3 Participants	2 Participants

Deaths: 0 deaths

Diabetic, HbA1C >9%, Insulin Glulisine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Control, Non-diabetic, no Treatment n=84 participants at risk Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin n=3 participants at risk Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin n=4 participants at risk Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin n=21 participants at risk Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Metformin and Insulin Glargine n=2 participants at risk Participants with a history of diabetes and with HbA1C \<7% who were discharged on metformin and insulin glargine, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine n=4 participants at risk Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin n=14 participants at risk Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine n=7 participants at risk Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine n=20 participants at risk Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine n=4 participants at risk Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine n=12 participants at risk Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
Cardiac disorders Cardiac disorder resulting in inpatient death	1.2% 1/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	14.3% 2/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	25.0% 1/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Cardiac disorders Cardiac disorder resulting in death during hospital readmission	0.00% 0/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	25.0% 1/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.

Other adverse events

Other adverse events
Measure	Control, Non-diabetic, no Treatment n=84 participants at risk Participants who did not have coronary artery bypass graft surgery (CABG), with no history of diabetes and with HbA1C \<7%, who did not require subcutaneous insulin in the hospital and were discharged with no antidiabetic therapy.	Non-diabetic, Metformin n=3 participants at risk Participants without a history of diabetes and with HbA1C \<7%, who were discharged on oral metformin following CABG surgery.	Non-diabetic, Insulin n=4 participants at risk Participants without a history of diabetes and with HbA1C\< 7% and persistent hyperglycemia requiring subcutaneous insulin therapy in the hospital who were discharged without oral diabetes medication, following CABG surgery.	Diabetic, HbA1C <7%, Metformin n=21 participants at risk Participants with a history of diabetes and with HbA1C \<7% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C <7%, Metformin and Insulin Glargine n=2 participants at risk Participants with a history of diabetes and with HbA1C \<7% who were discharged on metformin and insulin glargine, following CABG surgery.	Diabetic, HbA1C <7%, Insulin Glargine n=4 participants at risk Participants with a history of diabetes and with HbA1C \<7% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C 7%- 9%, Metformin n=14 participants at risk Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin, following CABG surgery.	Diabetic, HbA1C 7%-9%, Metformin and Insulin Glargine n=7 participants at risk Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on oral metformin plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose, following CABG surgery.	Diabetic, HbA1C 7%-9%, Insulin Glargine n=20 participants at risk Participants with a history of diabetes and with HbA1C between 7% and 9% who were discharged on glargine insulin (a long-acting basal insulin analogue), following CABG surgery.	Diabetic, HbA1C >9%, Metformin and Insulin Glargine n=4 participants at risk Participants with a history of diabetes and with HbA1C \>9% who were discharged on oral metformin and glargine insulin to be taken daily at the same time of day or a basal bolus insulin regimen, following CABG surgery.	Diabetic, HbA1C >9%, Insulin Glulisine n=12 participants at risk Participants with a history of diabetes and with HbA1C \>9% who were discharged on glulisine, a rapid-acting insulin to be taken before meals, following CABG.
Social circumstances Trauma from car accident	1.2% 1/84 • Number of events 1 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	8.3% 1/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Blood and lymphatic system disorders Hematoma	0.00% 0/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	33.3% 1/3 • Number of events 1 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Gastrointestinal disorders Stomach virus	0.00% 0/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	16.7% 2/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Renal and urinary disorders Bladder cancer	0.00% 0/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	25.0% 1/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Blood and lymphatic system disorders Anemia	0.00% 0/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	25.0% 1/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Blood and lymphatic system disorders Necrotic ulcer	0.00% 0/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	25.0% 1/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Hepatobiliary disorders Cholecystectomy	1.2% 1/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Gastrointestinal disorders Lower gastrointestinal bleeding	1.2% 1/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Vascular disorders Hypotension	1.2% 1/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
General disorders Seizure	1.2% 1/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Renal and urinary disorders Nephrolithiasis	1.2% 1/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.
Musculoskeletal and connective tissue disorders Gout	0.00% 0/84 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/3 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	4.8% 1/21 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/2 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/14 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/7 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/20 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/4 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.	0.00% 0/12 • Adverse events were collected from the time a participant signed the consent form until one month after hospital discharge. Mortality data includes participants who died prior to initial hospital discharge plus those who died during the study follow-up period. Any post-operative complications (including infections and wound infections) are captured as adverse events.

Additional Information

Dr. Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place