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Most coronary artery bypass graft surgery (CABG) patients develop high blood sugar while they are in the hospital. No studies have shown what the best insulin regimen is for CABG patients with type 2 diabetes is after going home from the hospital. Patients with high blood sugar and diabetes after cardiac bypass surgery will be followed for 3 months to look at how well their treatment(s) for diabetes work after discharge. Patients with diabetes will be discharged on oral antidiabetic drugs or with insulin glargine injections based on their sugar control. Patients with admission HbA1c < 7% (a laboratory value that shows the average blood sugar level in the body over 3 months) will be discharged on the same diabetes medications that they used before coming to the hospital. Those with an HbA1c between 7% and 9% will be discharged on insulin glargine at 50%-80% of the dose used in the hospital and oral antidiabetic drugs. Those with an HbA1c > 9% will be discharged on glargine at 80-100% of the dose used in the hospital in addition to oral antidiabetic drugs or with insulin glargine and insulin glulisine. The primary outcome will be a change in HbA1c at 4 and 12 weeks after discharge.
Hospital discharge represents a critical time for ensuring a safe transition to the outpatient setting and reducing the need for emergency department visits and re-hospitalization. Poor coordination of patient care and education on insulin administration at the time of patient discharge to home may be associated with medical errors that may increase risk of hypoglycemia, hyperglycemia and hospital readmission. No prospective studies have examined the impact of a discharge treatment regimen after cardiac surgery. Therefore, this study aims to determine the efficacy and safety of an HbA1c based treatment algorithm in controlling blood glucose (BG) after discharge. The total duration of the study is 3 months.
This study will include diabetic and non-diabetic subjects who participated in the American Diabetes Association (ADA) trial entitled "Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery." The ADA study is a two-arm randomized multicenter, open-label controlled trial aimed to determine if intensive insulin control with a BG target of 100-140mg/dl will reduce perioperative complications compared to a conventional BG control with a target of 141-180 mg/dl in hyperglycemic subjects who undergo coronary artery bypass graft surgery (CABG).
Treatment recommendations at discharge:
Patients with admission HbA1c < 7%:
Patients with Admission HbA1c between 7% and 9%:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control HbA1c < 7% | No Intervention | Subjects not requiring coronary artery bypass graft surgery (CABG), with no history of diabetes with HbA1c <7% not requiring subcutaneous insulin in the hospital will be discharged on no antidiabetic therapy. | |
| Diabetic/ Metformin and 50-Glargine HbA1c 7%- 9% | Active Comparator | Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of total daily hospital dose. |
|
| Diabetic/ Metformin and 80-Glargine HbA1c 7%-9%% | Active Comparator | Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c 7%- 9% will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of total daily hospital dose or with basal bolus regimen at same inpatient total daily insulin dose. |
|
| No diabetes/ Metformin only | Active Comparator | Subjects requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Patients without a history of diabetes and admission HbA1c < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy. Treatment naïve patients with an HbA1c between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy, Measured by a Change in HbA1c Levels | 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. | One month after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Readmitted to the Hospital | The number of participants that were readmitted to the hospital 3 months after initial hospital discharge | 3 months after discharge |
| The Number of Participants Experiencing a Hypoglycemic Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo E Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory Midtown Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Non-diabetic, Metformin | Participants without a history of diabetes and with HbA1C <7%, who were discharged on oral metformin following CABG surgery. |
| FG002 | 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. |
| FG003 | Diabetic, HbA1C <7%, Metformin | Participants with a history of diabetes and with HbA1C <7% who were discharged on oral metformin, following CABG surgery. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| FG010 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Non-diabetic, Metformin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy, Measured by a Change in HbA1c Levels | 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. | 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. | Posted | Mean | Standard Deviation | percent of glycosylated hemoglobin | One month after hospital discharge |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder resulting in inpatient death | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trauma from car accident | Social circumstances | Non-systematic Assessment |
The study had participants from other states who lived more than 50 miles away from the hospitals and did not return for their post-operative care or 12 week follow up. Some subjects preferred to complete follow ups via phone and no blood was drawn.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guillermo Umpierrez | Emory University | 404-778-1665 | geumpie@emory.edu |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069036 | Insulin Glargine |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D049528 |
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| Diabetic/antidiabetic regimen | Active Comparator | Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen. Subjects will receive one of the three treatment options based on their blood glucose levels: Metformin alone, both metformin and glargine insulin or glargine alone. |
|
| No diabetes/ Insulin only | Active Comparator | Subjects requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c <7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital. |
|
| Diabetes/Insulin only | Active Comparator | Subjects requiring coronary artery bypass graft surgery (CABG) with an admission HbA1c >9% and persistent hyperglycemia will be given basal insulin (glargine) once daily, at the same time of the day and rapid-acting insulin (glulisine) before meals. |
|
|
|
| Glargine insulin | Drug | Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day. Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose. Patients with an HbA1c > 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose. |
|
|
| Glulisine | Drug | Glulisine is an injectable, recombinant insulin analog. The total daily dose varies between 0.5 to 1 unit/kg/day depending on the levels of blood glucose. Glulisine will be given within 15 minutes before a meal or within 20 minutes after starting a meal. |
|
|
The number of participants that experienced hypoglycemia, defined as blood glucose levels ≤70 mg/dl.
| 3 months after discharge |
| The Number of Participants Experiencing a Severe Hypoglycemic Event | The number of participants that experienced severe hypoglycemia, defined as blood glucose levels ≤ 40 mg/dl. | 3 months after discharge |
| Number of Participants Experiencing a Hyperglycemic Event | The number of participants that experienced hyperglycemia, defined as blood glucose levels ≥ 140 mg/dl. | 3 months after discharge |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30326 | United States |
| Death |
|
| Adverse Event |
|
Participants without a history of diabetes and with HbA1C <7%, who were discharged on oral metformin following CABG surgery. |
| BG002 | 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. |
| BG003 | Diabetic, HbA1C <7%, Metformin | Participants with a history of diabetes and with HbA1C <7% who were discharged on oral metformin, following CABG surgery. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | 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. |
| BG010 | 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. |
| BG011 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Non-diabetic, Metformin | Participants without a history of diabetes and with HbA1C <7%, who were discharged on oral metformin following CABG surgery. |
| OG002 | 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. |
| OG003 | Diabetic, HbA1C <7%, Metformin | Participants with a history of diabetes and with HbA1C <7% who were discharged on oral metformin, following CABG surgery. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
| OG009 | 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. |
|
|
| Secondary | Number of Participants Readmitted to the Hospital | The number of participants that were readmitted to the hospital 3 months after initial hospital discharge | This analysis includes participants who completed the month 3 study visit either in person or by phone. | Posted | Number | participants | 3 months after discharge |
|
|
|
| Secondary | The Number of Participants Experiencing a Hypoglycemic Event | The number of participants that experienced hypoglycemia, defined as blood glucose levels ≤70 mg/dl. | This analysis includes participants who completed the month 3 study visit either in person or by phone. | Posted | Count of Participants | Participants | 3 months after discharge |
|
|
|
| Secondary | The Number of Participants Experiencing a Severe Hypoglycemic Event | The number of participants that experienced severe hypoglycemia, defined as blood glucose levels ≤ 40 mg/dl. | Participants who completed the Month 3 study visit in person or by phone. | Posted | Count of Participants | Participants | 3 months after discharge |
|
|
|
| Secondary | Number of Participants Experiencing a Hyperglycemic Event | The number of participants that experienced hyperglycemia, defined as blood glucose levels ≥ 140 mg/dl. | Participants who completed the Month 3 study visit, in person or by phone. | Posted | Count of Participants | Participants | 3 months after discharge |
|
|
|
| 5 |
| 84 |
| 1 |
| 84 |
| 6 |
| 84 |
| EG001 | Non-diabetic, Metformin | Participants without a history of diabetes and with HbA1C <7%, who were discharged on oral metformin following CABG surgery. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG002 | 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. | 1 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Diabetic, HbA1C <7%, Metformin | Participants with a history of diabetes and with HbA1C <7% who were discharged on oral metformin, following CABG surgery. | 0 | 21 | 0 | 21 | 1 | 21 |
| EG004 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG005 | 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. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG006 | 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. | 1 | 12 | 2 | 14 | 0 | 14 |
| EG007 | 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG008 | 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. | 2 | 20 | 0 | 20 | 0 | 20 |
| EG009 | 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. | 0 | 4 | 1 | 4 | 2 | 4 |
| EG010 | 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. | 1 | 12 | 0 | 12 | 3 | 12 |
| Cardiac disorder resulting in death during hospital readmission | Cardiac disorders | Non-systematic Assessment |
|
| Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Stomach virus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bladder cancer | Renal and urinary disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Necrotic ulcer | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cholecystectomy | Hepatobiliary disorders | Non-systematic Assessment |
|
| Lower gastrointestinal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Seizure | General disorders | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |