Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients

Study Overview
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Brief Summary
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Diabetes mellitus is associated with negative outcomes in patients undergoing surgery. Blood sugar levels are monitored by measuring a values that include but are not limited to hemoglobin A1c, capillary blood glucose, and fructosamine . This study is being done to investigate if there is an associated between these values and postsurgical outcomes.

Detailed Description
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This study aims to compare the predictive capacity of both fructosamine and HbA1c on preoperative basal glucose level, as well as adverse events (cardiovascular events, surgical site infection, and mortality) and length of post-anesthesia care unit (PACU) stay in both Type I and Type II diabetic patients. Secondary outcomes include length of anesthesia administration, an indicator of intraoperative complications, and perioperative glucose level.

Official Title
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Prospective, Observational Study Evaluating the Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients Undergoing Surgeries

Conditions
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Diabetes

Intervention / Treatment
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* Diagnostic Test: Capillary blood glucose blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients able to consent. Patients with either Type I or Type II diabetes mellitus (DM) Patients undergoing non-cardiac surgeries under general anesthesia ≥ 18 years of age Exclusion Criteria: Inability to read, understand or sign the consent form End-stage renal disease Special populations (Incarcerated individuals, pregnant female patients)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical patients<br>Diabetic patients scheduled to undergo non-cardiac surgery | Diagnostic Test: Capillary blood glucose blood draw<br>* Capillary blood glucose (CBG), HbA1c, fructosamine, albumin, BUN, and creatinine values will be obtained from a blood draw as a standard of care<br>* Other names: CBG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting capillary blood glucose level | Association between pre-operative HbA1c and fructosamine with pre-operative, fasting capillary blood glucose level measured the morning of surgery in preoperative holding area. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoglycemia | i. Incidence of hypoglycemia, defined as CBG < 70 mg/dL, during the perioperative period | 1 day | 
| hyperglycemia | ii. Incidence of hyperglycemia, defined as CBG > 180 mg/dL, during the perioperative period | 1 day | 
| infection | Incidence of wound infection | 1 day | 
| wound healing | Incidence of poor wound healing | 1 day | 
| delirium | Incidence of post-operative delirium | 1 day | 
| reoperation | Incidence of reoperation procedure | 1 day | 
| LOS | Length of PACU stay | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemoglobinA1c, serum fructosamine, glycemic control