| Literature DB >> 35276324 |
Ann T Sweeney1, Samara Pena2, Jeena Sandeep2, Bryan Hernandez2, Ye Chen3, Janis L Breeze3, Aysegul Bulut2, Karen Feghali2, Moaz Abdelrehim2, Mohamed Abdelazeem2, Padmavathi Srivoleti2, Linda Salvucci2, Susan Berry Cann2, Catalina Norman2.
Abstract
OBJECTIVE: Continuous glucose monitoring (CGM) has demonstrated benefits in managing inpatient diabetes. We initiated this single-arm pilot feasibility study during the COVID-19 pandemic in 11 patients with diabetes to determine the feasibility and accuracy of real-time CGM in patients who underwent cardiac surgery and whose care was being transitioned from the intensive care unit.Entities:
Keywords: Clark error grid (CEG) analyses; cardiac surgery; chronic kidney disease (CKD); continuous glucose monitoring (CGM); mean absolute relative difference (MARD); noncritically ill
Mesh:
Substances:
Year: 2022 PMID: 35276324 PMCID: PMC8902897 DOI: 10.1016/j.eprac.2022.03.001
Source DB: PubMed Journal: Endocr Pract ISSN: 1530-891X Impact factor: 3.701
Summary Statistics of Demographic Characteristics and Risk Factors
| Overall ( | |
|---|---|
| Demographic characteristics | … |
| Age, y, mean (SD) | 72.5 (4.3) |
| Male | 8 (72.7) |
| Minority race/ethnicity | … |
| African American | 1 (9.1) |
| Asian | 1 (9.1) |
| Hispanic | 1 (9.1) |
| Weight, kg, mean (SD) | 84.8 (17.9) |
| BMI, kg/m2, mean (SD) | 30.6 (5.2) |
| HbA1c, median (IQR) | 7.8% (62 mmol/mol) (7.4%, 10.3% [57 mmol/mol, 89 mmol/mol]) |
| DM complications | … |
| Retinopathy (%) | 0 (0.0) |
| Nephropathy eGFR (%) | 9 (81.8) |
| CKD stage (%) | … |
| II | 1 (9.1) |
| IIIA | 2 (18.2) |
| IIIB | 3 (27.3) |
| IV | 2 (18.2) |
| V | 1 (9.1) |
| Neuropathy (%) | 3 (27.3) |
| CAD (%) | 11 (100.0) |
| CVA (%) | 0 (0.0) |
| PVD (%) | 2 (18.2) |
| Risk factors for hypoglycemia | … |
| Age of >67 y (%) | 9 (81.8) |
| BMI of <27 kg/m2 (%) | 4 (36.4) |
| Renal failure: eGFR of <60 mL/min/1.73 m2 | |
| Malnutrition (%) | 0 (0.0) |
| History of recent hypoglycemia (6-8 wk) (%) | 0 (0.0) |
| Long DM duration >20 y (%) | 7 (63.6) |
| CHF (%) | 7 (63.6) |
| After cardiac surgery (%) | … |
| CABGX2 | 2 (18.2) |
| CABGX3 | 1 (9.1) |
| CABGX4 | 7 (63.6) |
| MVR/TVR | 1 (9.1) |
Abbreviations: BMI = body mass index; CABG = coronary artery bypass graft; CAD = coronary artery disease; CHF = congestive heart failure; CKD = chronic kidney disease; CVA = cerebrovascular accident; DM = diabetes mellitus; eGFR = estimated glomerular filtration rate; HbA1c = glycated hemoglobin; IQR = interquartile range; MVR = mitral valve replacement; PVD = peripheral vascular disease; TVR = tricuspid valve replacement.
Summary Statistics of Outcomes Over 3 Days
| Outcomes | Overall ( |
|---|---|
| % Time in range 70-180 mg/dL, mean (SD) | 59.8 (22.7) |
| % Time hypoglycemia of <70 mg/dL, mean (SD) | 1.4 (2.0) |
| % Time hypoglycemia of <54 mg/dL, mean (SD) | 0.3 (0.9) |
| % Time hyperglycemia of >180 mg/dL, mean (SD) | 38.8 (22.1) |
| Number of patients with any hypoglycemic excursion glucose level of <70 mg/dL for >20 min (%) | 1 (10.0) |
| The 3-day rate of hypoglycemic excursion glucose level of <70 mg/dL for >20 min (number of events per person-time) | 1/30 person-days |
| Total daily insulin dose on the final day, units/kg/d, mean (SD) | 0.6 (0.4) |
| Mean basal, units (SD) | 26.0 (16.8) |
| Mean bolus, units (SD) | 21.2 (16.0) |
One patient remained in hospital for <3 days.
There was only 1 patient with 1 incidence of hypoglycemic excursion (glucose level of <70 mg/dL) among 10 patients within the 3-day window.
Fig. 1Clarke grid analysis is used to compare the glucose measurement obtained from POC and CGM. A table is also provided with percentage of values of CGM that occur within different zones. Zone A: no effect on clinical action (CGM within 20% of POC). Zone B: altered clinical action with little to no effect on clinical outcome (>20% difference, no incorrect treatment). Zone C: altered clinical action, likely to affect clinical outcome (hyperglycemia or hypoglycemia leading to inappropriate treatment). Zone D: altered clinical action, could have significant medical risk (undetected hypoglycemia or hyperglycemia needing treatment). Zone E: altered clinical action, could have dangerous consequences (hypoglycemia mistaken for hyperglycemia, and vice versa). CGM = continuous glucose monitoring; POC = point-of-care.
Mean Absolute Relative Difference Between Point-of-Care and Continuous Glucose Monitoring
| ARD | Overall ( | eGFR ≥ 20 mL/min/1.73 m2 ( | eGFR < 20 mL/min/1.73 m2 ( |
|---|---|---|---|
| Mean (SD) | 14.80 (13.53) | 12.13 (7.67) | 21.27 (20.81) |
| Median (IQR) | 13.20 (5.22, 18.52) | 12.71 (5.35, 17.16) | 16.37 (5.09, 25.08) |
| (Minimum, maximum) | (0, 91.00) | (0, 34.95) | (0, 91.00) |
Abbreviations: ARD = absolute relative difference; eGFR = estimated glomerular filtration rate; IQR = interquartile range.
Mean absolute relative difference was calculated on the basis of 137 matched glucose pairs of 11 patients during their hospital stay; the maximum hospital stay is 76 hours. Mean absolute relative difference has also been shown for patients in different chronic kidney disease strata (those with eGFR of ≥20 mL/min/1.73 m2 and those with eGFR of <20 mL/min/1.73 m2).
Sensitivity Analysis: Mean Absolute Relative Difference for Glucose Measurement Within the First 24 Hours During Hospital Stay and Rest of Hospital Stay
| ARD | Overall ( | eGFR ≥ 20 mL/min/1.73 m2 ( | eGFR < 20 mL/min/1.73 m2 ( |
|---|---|---|---|
| Mean (SD) | 15.42 (14.44) | 12.80 (7.85) | 21.55 (23.02) |
| Median (IQR) | 14.78 (7.38, 20.18) | 12.65 (6.37, 17.63) | 18.32 (12.94, 20.96) |
| (Minimum, maximum) | (0.30, 91.00) | (0.30, 30.28) | (1.03, 91.00) |
Abbreviations: ARD = absolute relative difference; eGFR = estimated glomerular filtration rate; IQR = interquartile range.
Mean absolute relative difference has also been calculated in different chronic kidney disease strata (patients with eGFR of >20 mL/min/1.73 m2 and those with <20 mL/min/1.73 m2).
Sensitivity Analysis: Mean Absolute Relative Difference for Glucose Measurement After the First 24 Hours During Hospital Stay and Rest of Hospital Stay
| ARD | Overall ( | eGFR ≥ 20 mL/min/1.73 m2 ( | eGFR < 20 mL/min/1.73 m2 ( |
|---|---|---|---|
| Mean (SD) | 14.54 (13.21) | 11.86 (7.64) | 21.15 (20.23) |
| Median (IQR) | 13.14 (5.10, 18.06) | 12.71 (5.35, 16.67) | 14.71 (4.41, 29.46) |
| (Minimum, maximum) | (0, 73.33) | (0, 34.95) | (0, 73.33) |
Abbreviations: ARD = absolute relative difference; eGFR = estimated glomerular filtration rate; IQR = interquartile range.
Mean absolute relative difference has also been calculated in different chronic kidney disease strata (patients with eGFR of >20 mL/min/1.73 m2 and those with <20 mL/min/1.73 m2).
Fig. 2A, Summary data of CGM study patient, illustrating 65% time in range vs 0% hypoglycemia and 34% hyperglycemia. B, CGM data from a study patient, illustrating how overnight hypoglycemia and prolonged postprandial hyperglycemia are captured using CGM but C, are not detected via the standard fingerstick POC blood glucose level protocol. AGP = ambulatory glucose profile; BG = blood glucose; CGM = continuous glucose monitoring; GMI = glucose management indicator; POC = point-of-care.
| N | A (%) | B (%) | D (%) |
|---|---|---|---|
| 137 | 76.6 | 21.2 | 2.2 |