Safety and Efficacy of a Peri-Operative Protocol for Patients with Diabetes Treated with Continuous Subcutaneous Insulin Infusion who are Admitted for Same-Day Surgery

Objective: The number of people with diabetes using continuous subcutaneous insulin infusions (CSII) with an insulin pump has risen dramatically, creating new challenges when these patients are admitted to the hospital for surgical or other procedures. There is limited literature guiding CSII use during surgical procedures.Methods: The study was carried out in a large, urban, tertiary care hospital. We enrolled 49 patients using insulin pump therapy presenting for 57 elective surgeries. We developed a CSII peri-operative glycemic management protocol (PGMP) to standardize insulin pump management in patients admitted to a same-day surgery unit (SDSU). The purpose was evaluate the safety (% capillary blood glucose (CBG) <70 mg/dL and/or pump incidents) and efficacy (first postoperative CBG ≤200 mg/dL) of the CSII PGMP. We determine the contribution of admission CBG, type of anesthesia, surgery length, and peri-operative steroid use on postoperative glycemic control.Results: Overall, 63% of patients treated according to the CSII PGMP had a first postoperative CBG ≤200 mg/dL. There were no episodes of intra- or postoperative hypoglycemia. For patients treated with the CSII PGMP, the mean postoperative CBG was lower in patients with anticipated or actual surgical length ≤120 minutes (158.1 ± 53.9 vs. 216 ± 77.7 mg/dL, P<.01). No differences were observed with admission CBG, type of anesthesia, or steroid use.Conclusions: This study demonstrates that a CSII PGMP is both safe and effective for patients admitted for elective surgical procedures and provides an example of a standardized protocol for use in clinical practice.Abbreviations: A1C = glycated hemoglobin BG = blood glucose CBG = capillary blood glucose CSII = continuous subcutaneous insulin infusion DM = diabetes mellitus EMR = electronic medical record IV = intravenous PGMP = peri-operative glycemic management protocol SDS = same-day surgery SDSU = same-day surgery unit SQ = subcutaneous UC = usual care     

Comparison of Basal Insulin Regimens on Glycemic Variability in Noncritically Ill Patients with Type 2 Diabetes

Objective: To evaluate the impact of different subcutaneous basal insulin regimens on glycemic variability (GV) and hospital complications in non-intensive care unit (ICU) patients with type 2 diabetes (T2D).Methods: This study is a post hoc analysis of 279 general medicine and surgery patients treated with either a “Basal Bolus” insulin regimen using glargine once daily and glulisine before meals or a “Basal Plus” regimen using glargine once daily plus correction doses of glulisine before meals for glucose >140 mg/dL. GV was calculated as mean delta (Δ) daily glucose, mean SD, and mean amplitude of glycemic excursions (MAGE).Results: Treatment with Basal Bolus and Basal Plus regimens resulted in similar mean daily glucose, hypoglycemia, length of stay (LOS), and hospital complications (all P>.05). There were no differences in GV between treatment groups by Δ change (72.5 ± 36 vs. 69.3 ± 34 mg/dL), SD (38.5 ± 18 vs. 37.1 ± 16 mg/dL) and MAGE (67.5 ± 34 vs. 66.1 ± 39 mg/dL) (all P>.05). Surgery patients treated with Basal Bolus had higher GV compared to those treated with Basal Plus (Δ daily glucose and SD: P = .02, MAGE: P = .009), but no difference in GV was found between treatment groups for the general medicine patients (P>.05). Patients with hypoglycemia events had higher GV compared to subjects without hypoglycemia (P<.05), but no association was found between GV and hospital complications (P>.05).Conclusion: Treating hospitalized, non-ICU, diabetic patients with Basal Plus insulin regimen resulted in similar glucose control and GV compared to the standard Basal Bolus insulin regimen. Higher GV was not associated with hospital complications.Abbreviations:BG = blood glucoseCV= coefficient of variationGV= glycemic variabilityICU = intensive care unitLOS = length of stayMAGE = mean amplitude of glycemic excursionsSSI = sliding scale insulinT2D = type 2 diabetesTDD =total daily dose     

Glycemic Control with use of Insulin Glargine after Cardiothoracic Surgery: A Retrospective Study

ObjectivePerioperative glycemic control in critically ill cardiothoracic surgery patients may improve postsurgical outcomes. The objective of the study was to compare outcomes before and after the implementation of a protocol using subcutaneous (SC) glargine at transition from intravenous insulin infusion (IVII).MethodsIn August 2006, the Cleveland Clinic began using glargine and supplemental rapid-acting sliding scale insulin (SSI) at transition from IVII (glargine-SSI group). Before August 2006, only supplemental insulin was used (SSI-only group). The primary outcome was first blood glucose (BG1) after discontinuation of IVII. Secondary outcomes included the absolute difference between the last glucose before discontinuation of IVII (BG0) and BG1, mean glucose in the first 24 hours after discontinuation of IVII (BG24), need for SSI, and hypoglycemia.ResultsMean BG0, BG1, and BG24, and the difference between BG1 and BG0 and between BG24 and BG0 were not significantly different between groups. Diabetes mellitus (DM) patients who had received glargine had a lower mean difference between BG1 and BG0 and a lower mean BG24 than those who had not received glargine (14.6 mg/dL vs. 33.1 mg/dL; P = .20, and 163.8 mg/dL vs. 177.9 mg/dL; P = .29, respectively). A higher proportion of DM patients needed SSI than did non-DM patients (82% vs. 36%; P<.001).ConclusionGlargine administered at the cessation of IVII enabled less SSI coverage in diabetic patients subsequent to transition from IVII. However, there was no significant difference in BG control between the glargine-SSI and SSI-only groups. Prospective studies involving more patients are needed to show possible clinically significant benefits of this intervention. (Endocr Pract. 2013;19:485-493)     

Inpatient Hypoglycemic Events in a Comparative Effectiveness Trial for Glycemic Control in a High-Risk Population

Objective: Inpatient hypoglycemia (glucose ≤70 mg/dL) is a limitation of intensive control with insulin. Causes of hypoglycemia were evaluated in a randomized controlled trial examining intensive glycemic control (IG, target 140 mg/dL) versus moderate glycemic control (MG, target 180 mg/dL) on post–liver transplant outcomes.Methods: Hypoglycemic episodes were reviewed by a multidisciplinary team to calculate and identify contributing pathophysiologic and operational factors. A subsequent subgroup case control (1:1) analysis (with/without) hypoglycemia was completed to further delineate factors. A total of 164 participants were enrolled, and 155 patients were examined in depth.Results: Overall, insulin-related hypoglycemia was experienced in 24 of 82 patients in IG (episodes: 20 drip, 36 subcutaneous [SQ]) and 4 of 82 in MG (episodes: 2 drip, 2 SQ). Most episodes occurred at night (41 of 60), with high insulin amounts (44 of 60), and during a protocol deviation (51 of 60). Compared to those without hypoglycemia (n = 127 vs. n = 28), hypoglycemic patients had significantly longer hospital stays (13.6 ± 12.6 days vs. 7.4 ± 6.1 days; P = .002), higher peak insulin drip rates (17.4 ± 10.3 U/h vs. 13.1 ± 9.9 U/h; P = .044), and higher peak insulin glargine doses (36.8 ± 21.4 U vs. 26.2 ± 24.3 U; P = .035). In the case-matched analysis (24 cases, 24 controls), those with insulin-related hypoglycemia had higher median peak insulin drip rates (17 U/h vs. 11 U/h; P = .04) and protocol deviations (92% vs. 50%; P = .004).Conclusion: Peak insulin requirements and protocol deviations were correlated with hypoglycemia.Abbreviations:DM = diabetes mellitusICU = intensive care unitIG = intensive glycemic controlMELD = Model for End-stage Liver DiseaseMG = moderate glycemic controlSQ = subcutaneous     

Computerized Physician Order Entry- Based Hyperglycemia Inpatient Protocol and Glycemic Outcomes: The CPOE-HIP Study

ObjectiveTo evaluate the impact of implementing a computerized physician order entry (CPOE)-based hyperglycemia inpatient protocol (HIP) on glycemic outcomes.MethodsThis retrospective, cross-sectional study compared blood glucose values, hemoglobin A_1c values, diabetes medication profiles, and demographic data of diabetic patients admitted to medicine services between March 15, 2006, and April 11, 2006 (before CPOE-HIP protocol was adopted), with data of diabetic patients admitted between October 3, 2007, and October 30, 2007 (1 year after CPOE-HIP protocol was implemented).ResultsA total of 241 diabetic patients comprised the pre-CPOE-HIP group and 197 patients comprised the post-CPOE-HIP group. After the protocol was adopted, there was a decrease of 10.8 mg/dL in the mean glucose concentration per patient-day (175.5 ± 81.2 mg/dL vs 164.7 ± 82 mg/dL, P < .001). Additional glycemic control improvements included a 5% increase in patient-days with serum glucose concentrations between 70 and 150 mg/ dL (41.1% vs 46.1%, P = .008) and a 3.1% decrease in patient-days with glucose concentrations above 299 mg/dL (16.9% vs 13.8%, P = .023). The percentage of patientdays with glucose concentrations less than or equal to 50 mg/dL was not significantly different (0.95% vs 1.27%, P = .15). Compliance with the American Diabetes Association recommendation for hemoglobin A_1c inpatient testing frequency increased from 37.3% to 64.5% (P < .001). The length of stay did not differ between the groups.ConclusionsImplementation of a hospital-wide, CPOE-based, hyperglycemia management protocol had a favorable impact onglucose targets, decreasing excessively high glucose levels without increasing clinically meaningful hypoglycemic events. Compliance with hemoglobin A_1c testing recommendations also improved. (Endocr Pract. 2010;16:389-397)     

Hypoglycemia Rates After Restriction of High-Dose Glargine in Hospitalized Patients

Objective: Hypoglycemia remains one of the main challenges of insulin therapy. To reduce insulin-related hypoglycemia at our institution, we restricted inpatient ordering of high glargine doses (≥0.5 U/kg/day) to endocrine staff in May 2013. This retrospective cohort study assesses its effect on hypoglycemia and glycemic control within 48 hours of admission (ADM).Methods: We identified 692 adult patients hospitalized at Boston Medical Center who received glargine upon ADM from November 1, 2012 through April 30, 2013 as the pre-intervention group, and 651 adult patients admitted between November 1, 2013 and April 30, 2014 as the postintervention group. Demographics, medical history, home insulin regimen, concurrent oral diabetes medications or glucocorticoid administration, ADM serum creatinine, all blood glucose levels (BG) ≤48 hours of ADM, and hemoglobin A1c values ≤3 months were assessed. Hypoglycemia was defined as BG ≤70 mg/dL, and hyperglycemia as BG ≥200 mg/dL. Multivariable regression models assessed potential associations between covariates and incidence of hypoglycemia and average BG ≤48 hours of ADM.Results: Demographics were similar between groups. Significantly less patients received high-dose glargine in the post-intervention group (5.2% vs. 0.3%, P<.001). Incidences of hypoglycemia were significantly lower in the postintervention group (20.9% vs. 17.8%, P<.001 per ADM; 3.4% vs. 2.3%, P = .001 per BG measurements [BGM]). Mean BG levels ≤48 hours of ADM and incidence of hyperglycemia were not significantly different. The adjusted incident rate ratio of hypoglycemia was 0.63 per ADM and 0.74 per BGM in the postintervention group compared to the pre-intervention group (P = .001 and P = .063, respectively).Conclusion: We found that implementation of a restriction on high doses of glargine resulted in lower rates of hypoglycemia without worsening glycemic control.Abbreviations:ADM = admissionBG = blood glucoseBGM = blood glucose measurementsBMC = Boston Medical CenterBMI = body mass indexEMR = electronic medical recordHgbA1c = hemoglobin A1cIRR = incidence rate ratioNPH = neutral protamine HagedornTDD = total daily doseT2D = type 2 diabetes     

Addressing Pitfalls in Management of Diabetic Ketoacidosis with a Standardized Protocol

Objective: To determine the efficacy and safety of a diabetic ketoacidosis (DKA)-Power Plan (PP) for guiding intravenous (IV) insulin infusions prior to anion gap (AG) closure and administering subcutaneous (SC) insulin ≥1 hour before discontinuing IV insulin.Methods: Retrospective chart review of patients with DKA before (pre-PP) (n = 60) and following (post-PP) (n = 60) implementation of a DKA-PP. Groups were compared for percentage of patients for whom IV insulin therapy was continued until AG closure, the percentage of patients receiving SC insulin ≥1 hour before discontinuation of IV insulin, and percentage of patients with rebound DKA during the index hospitalization.Results: Admission plasma glucose (514 mg/dL vs. 500 mg/dL; P = .36) and venous pH (7.2 vs. 7.2; P = .57) were similar in pre- and post-PP groups. Inappropriate discontinuation of IV insulin occurred less frequently in post-PP patients (28% vs. 7%; P = .007), with a lower frequency of rebound DKA (40% vs. 8%; P = .001) following acute management. More post-PP patients received SC insulin ≥1 hour before discontinuation of IV insulin (65% vs. 78%; P = .05).Conclusion: Implementation of a DKA-PP was associated with appropriate discontinuation of IV insulin in more patients, more frequent administration of SC insulin ≥1 hour prior to discontinuation of IV insulin, and fewer episodes of rebound DKA.Abbreviations: ADA = American Diabetes Association; AG = anion gap; BG = blood glucose; DKA = diabetic ketoacidosis; DKA-PP = DKA-Power Plan; ICU = intensive care unit; IQR = interquartile range; IV = intravenous; IVF = IV fluid; LOS = length of stay; SC = subcutaneous     

Effects of a Computerized Order Set on the Inpatient Management of Hyperglycemia: A Cluster-Randomized Controlled Trial

ObjectiveTo determine the effects of a computerized order set on the inpatient management of diabetes and hyperglycemia.MethodsWe conducted a cluster-randomized controlled trial on the general medical service of an academic medical center staffed by residents and hospitalists. Consecutively enrolled patients with diabetes mellitus or inpatient hyperglycemia were randomized on the basis of their medical team to usual care (control group) or an admission order set built into the hospital’s computer provider order entry (CPOE) system (intervention group). All teams received a detailed subcutaneous insulin protocol and case-based education. The primary outcome was the mean percent of glucose readings per patient between 60 and 180 mg/dL.ResultsBetween April 5 and June 22, 2006, we identified 179 eligible study subjects. The mean percent of glucose readings per patient between 60 and 180 mg/dL was 75% in the intervention group and 71% in the usual care group (adjusted relative risk, 1.36; 95% confidence interval, 1.03 to 1.80). In comparison with usual care, the intervention group also had a lower patient-day weighted mean glucose (148 mg/dL versus 158 mg/dL, P = .04), less use of sliding-scale insulin by itself (25% versus 58%, P = .01), and no significant difference in the rate of severe hypoglycemia (glucose < 40 mg/dL; 0.5% versus 0.3% of patient-days, P = .58).ConclusionThe use of an order set built into a hospital’s CPOE system led to improvements in glycemic control and insulin ordering without causing a significant increase in hypoglycemia. Other institutions with CPOE should consider adopting similar order sets as part of a comprehensive inpatient glycemic management program. (Endocr Pract. 2010;16:209-218)     

A Retrospective Study Comparing Neutral Protamine Hagedorn Insulin With Glargine As Basal Therapy In Prednisone-Associated Diabetes Mellitus In Hospitalized Patients

ObjectiveTo compare glycemic outcomes in hospitalized patients with or without type 2 diabetes mellitus receiving neutral protamine Hagedorn insulin (NPH) vs glargine as basal insulin for management of glucocorticoid-associated hyperglycemia.MethodsWe conducted a retrospective review of electronic medical records in prednisone-treated adult patients with hyperglycemia in a university hospital. Consecutive patients were selected in both the NPH and glargine cohorts using inclusion and exclusion criteria. Baseline characteristics were assessed in each cohort. Glycemic outcomes were analyzed by comparing fasting blood glucose, mean daily blood glucose concentration, median daily blood glucose concentration, and the number of hypoglycemic episodes on a prespecified index day.ResultsOne hundred twenty patients were included: 60 patients in the NPH cohort and 60 patients in the glargine cohort. The weight-based insulin requirement was lower in the NPH cohort than in the glargine cohort (0.27 ± 0.2 units/kg vs 0.34 ± 0.2 units/kg [P = .04] for basal insulin and 0.26 ± 0.2 units/kg vs 0.36 ± 0.2 units/kg [P = .03] for bolus insulin). NPH and glargine cohorts were similar regarding age, sex, race, body mass index, hemoglobin A_1c, serum creatinine, and prednisone dosage. Glycemic outcomes in the NPH cohort compared with outcomes in the glargine cohort were similar regarding mean fasting blood glucose concentration (134 ± 49 mg/dL vs 139 ± 54 mg/dL [P = .63]), mean daily blood glucose (167 ± 46 mg/dL vs 165 ± 52 mg/dL [P = .79]), median blood glucose (160 ± 49 mg/dL vs 159 ± 57 mg/dL [P = .90]), and number of hypoglycemic episodes per day (0.12 ± 0.3 vs 0.10 ± 0.3 [P = .77]).ConclusionsNPH and glargine appear to be equally effective as basal insulin in the management of hyperglycemia in hospitalized patients receiving prednisone. However, the total daily insulin doses used were lower in the NPH cohort. (Endocr Pract. 2012;18:712-719)     

Comparison of 3 Algorithms for Basal Insulin in Transitioning from Intravenous to Subcutaneous Insulin in Stable Patients after Cardiothoracic Surgery

ObjectiveTo determine the effectiveness of an algorithm containing 1 of 3 initial subcutaneous doses of insulin detemir and flexible prandial and supplemental insulin aspart in stable patients who have undergone cardiac surgery and are being transitioned off intravenous insulin infusion.MethodsPatients were extubated, were not taking vasopressors, and were otherwise stable, requiring at least 1 unit per hour of intravenous insulin at least 48 hours after surgery. Patients were randomly assigned to once-daily insulin detemir at 50%, 65%, or 80% of intravenous basal insulin requirements and received insulin aspart according to carbohydrate intake. The dose of insulin detemir was adjusted daily over 72 hours.ResultsEighty-two patients were included. The percentages of patients with an initial morning glucose concentration of 80 to 130 mg/dL were 36%, 63%, and 56% of patients at the 50%, 65%, and 80% doses, respectively (P = .12). However, the mean overall glucose value at 24 and 72 hours was similar between groups, and 86%, 93%, and 92% of patients in each group, respectively, achieved a mean glucose concentration of 80 to 180 mg/dL at 72 hours (P = .60). Hypoglycemia (glucose < 65 mg/dL) only occurred in the 65% group (21%) and the 80% group (12%) over the first 72 hours (P = .02 in the 50% group compared with the 65% and 80% groups combined) with 1 event of a glucose concentration less than 40 mg/dL in the 80% group. There was no loss of glycemic control by the end of the once-daily dosing interval.ConclusionsGlycemic targets can be achieved without hypoglycemia by 72 hours in most patients who have undergone cardiac surgery and require intravenous insulin with a regimen consisting of an initial insulin detemir dose of 50% of basal intravenous insulin requirements and prandial and supplemental insulin. (Endocr Pract. 2011; 17:753-758)     

Long-Acting Subcutaneously Administered Insulin for Glycemic Control Immediately After Cardiac Surgery

ObjectiveTo test the hypothesis that subcutaneous administration of basal insulin begun immediately after cardiac surgery can decrease the need for insulin infusion in patients without diabetes and save nursing time.MethodsAfter cardiac surgery, 36 adult patients without diabetes were randomly assigned to receive either standard treatment (control group) or insulin glargine once daily in addition to standard treatment (basal insulin group). Standard treatment included blood glucose measurements every 1 to 4 hours and intermittent insulin infusion to maintain blood glucose levels between 100 and 150 mg/dL. The study period lasted up to 72 hours.ResultsThere were no differences in demographics or baseline laboratory characteristics of the 2 study groups. Mean daily blood glucose levels were lower in the basal insulin group in comparison with the control group, but the difference was not statistically significant (129.3 ± 9.4 mg/ dL versus 132.6 ± 7.3 mg/dL; P = .25). The mean duration of insulin infusion was significantly shorter in the basal insulin group than in the control group (16.3 ± 10.7 hours versus 26.6 ± 17.3 hours; P = .04). Nurses tested blood glucose a mean of 8.3 ± 3.5 times per patient per day in the basal insulin group and 12.0 ± 4.7 times per patient per day in the control group (P = .01). There was no occurrence of hypoglycemia (blood glucose level < 60 mg/dL) in either group.ConclusionOnce-daily insulin glargine is safe and may decrease the duration of insulin infusion and reduce nursing time in patients without diabetes who have hyperglycemia after cardiac surgery. (Endocr Pract. 2011;17: 558-562)     

Safety and Efficacy of Glucostabilizer in the Management of Diabetic Ketoacidosis

Objective: To evaluate the safety and efficacy of GlucoStabilizer software intravenous insulin (IV) dosing in comparison to American Diabetes Association protocol-directed provider-guided insulin dose adjustment (PGIA).Methods: GlucoStabilizer calculates the dose of IV insulin required to reach a prescribed target glucose range. GlucoStabilizer has not been fully studied in DKA. This retrospective study compared outcomes in patients with DKA before and after the implementation of GlucoStabilizer. Insulin doses were administered based on GlucoStabilizer calculations or PGIA. The analysis evaluated before-after changes in the amount of insulin used, time to target, hypoglycemia or hypokalemia events, and the time to DKA resolution.Results: We studied 77 patients with insulin doses calculated by GlucoStabilizer and 69 patients with PGIA dosing. GlucoStabilizer was superior to PGIA. Patients treated with GlucoStabilizer-calculated doses did not experience hypoglycemia (N = 0 versus N = 10; P<.001). The 10 unique PGIA patients had a total of 18 episodes with 17 between 55 to 69 mg/dL; 1 <54 mg/dL, and no episodes <40 mg/dL. The GlucoStabilizer group required less insulin to reach DKA resolution (59.2 versus 101.2 units; P<.001). Time to glycemic target and DKA resolution were similar (6.7 versus 4.6 hours; P = .132) and (9.8 versus 9.9 hours; P = .803), respectively. No difference in the incidence of hypokalemia was seen (N = 9 versus N = 11; P = .48).Conclusion: This study demonstrates the Gluco Stabilizer settings that can be successfully used in the management of DKA with the avoidance of hypoglycemia. Patients treated with GlucoStabilizer-calculated doses experienced no hypoglycemia and required less insulin as compared to those managed with PGIA.Abbreviations: ADA = American Diabetes Association; DKA = diabetic ketoacidosis; ED = emergency department; eGMS = electronic glycemic management systems; ICU = intensive care unit; IV = intravenous; PGIA = protocol-directed provider-guided insulin dose adjustment     

Impaired Postoperative Hyperglycemic Stress Response Associated with Increased Mortality in Patients in the Cardiothoracic Surgery Intensive Care Unit

ObjectiveTo describe the association of tight glycemic control with intensive insulin therapy and clinical outcome among patients in the cardiothoracic surgery intensive care unit.MethodsAll patients who underwent cardiothoracic surgery and were admitted to the cardiothoracic surgery intensive care unit between September 13, 2007, and November 1, 2007, were enrolled. Clinical and metabolic data were prospectively collected. All patients received intensive insulin therapy using a nurse-driven dynamic protocol targeting blood glucose values of 80 to 110 mg/dL. Four stages of critical illness were defined as follows: acute critical illness (intensive care unit days 0-2), prolonged acute critical illness (intensive care unit 3 or more days), chronic critical illnesss (tracheotomy performed), and recovery (liberated from ventilator).ResultsOne hundred fourteen patients were enrolled. Seventy-three (64%) recovered during acute critical illness, 26 (23%) recovered during prolonged acute critical illness, and 15 (13%) progressed to chronic critical illness. All 6 deaths were among patients in chronic critial illness. Admission blood glucose and average blood glucose values for the first 12 hours were lower in patients who developed chronic critical illness and died and were higher in patients who developed chronic critical illness and survived (P = .007 and P = .007, respectively). Severe hypoglycemia (blood glucose < 40 mg/dL) occurred once (0.03% of all measurements). Lower initial blood glucose values, which reflect an impaired stress response immediately after surgery, were associated with increased mortality, and a significant delay in achieving tight glycemic control with intensive insulin therapy was associated with prolonged intensive care unit course, but no increase in mortality.ConclusionThe study findings suggest that acute postoperative hyperglycemia and its prompt correction with intensive insulin therapy are associated with favorable outcomes in patients in the cardiothoracic surgery intensive care unit. (Endocr Pract. 2010;16:798-804)     

A Comparison of Twice-Daily Biphasic Insulin Aspart 70/30 and Once-Daily Insulin Glargine in Persons With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Therapy: A Randomized,Open-Label Study

ObjectiveTo compare efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) with insulin (glargine) in type 2 diabetic patients who were not maintaining glycemic control on basal insulin and oral antidiabetic drugs.MethodsIn a 24-week, open-label, parallel-group trial, type 2 diabetic patients who were not maintaining glycemic control on basal insulin (glargine or neutral protamine Hagedorn) + oral antidiabetic drugs were randomly assigned to twice-daily BIAsp 30 + metformin or oncedaily glargine + metformin + secretagogues (secretagogues were discontinued in the BIAsp 30 arm).ResultsOne hundred thirty-seven patients were randomly assigned to the BIAsp 30 group and 143 patients were randomly assigned to the glargine group. Of 280 patients randomized, 229 (81.8%) completed the study. End-of-trial hemoglobin A_1c reductions were − 1.3% (BIAsp 30) vs − 1.2% (glargine) (treatment difference: 95% confidence interval, − 0.06 [− 0.32 to 0.20]; P = .657). Of patients taking BIAsp 30, 27.3% reached a hemoglobin A_1c level < 7.0% compared with 22.0% of patients taking glargine (treatment difference: P = .388). Glucose increment averaged over 3 meals was lower in the BIAsp 30 arm (treatment difference: − 17.8 mg/dL, P = .001). Fasting plasma glucose reductions from baseline were − 13.8 mg/ dL (BIAsp 30) vs − 42.5 mg/dL (glargine) (P = .0002). Final minor hypoglycemia rate, insulin dose, and weight change were higher in the BIAsp 30 arm (6.5 vs 3.4 events/patient per year, P <.05; 1.19 vs 0.63 U/kg; and 3.1 vs 1.4 kg, P = .0004, respectively).ConclusionsDespite not receiving secretagogues, patients taking BIAsp 30 + metformin achieved similar hemoglobin A_1c levels and lower postprandial plasma glucose compared with those receiving glargine + metformin + secretagogues. The large improvement in the glargine group suggests the patients were not true basal failures at randomization. While switching to BIAsp 30 improves glycemic control in this patient population, remaining on basal insulin and optimizing the dose may be equally effective in the short term. (Endocr Pract. 2011;17:41-50)     

Safety and Efficacy of an Insulin Infusion Protocol Designed for the Non-Intensive Care Setting

ObjectiveTo determine whether glycemic control can be safely achieved with use of a simplified insulin infusion protocol in hospitalized patients who are not in the intensive care unit (ICU).MethodsWe developed a novel intravenous insulin protocol specifically designed for use in the non-ICU setting. We then collected clinical data on the first 30 patients treated with use of this protocol. Our study focused on safety and glycemic control.ResultsThe insulin infusion protocol was used in 30 patients for a total of 634 hours. A single hypoglycemic episode (glucose level < 60 mg/dL) occurred in 3 patients. The target mean glucose level of < 150 mg/dL was achieved in 9 hours. Once the glucose target had been achieved, the mean and median glucose concentrations were 156 mg/dL and 140 mg/dL, respectively.ConclusionUse of a simple intravenous insulin protocol can safely and effectively control the blood glucose level in patients in a non-ICU setting. (Endocr Pract. 2009;15:682-688)     

Glycemic Control After Hospital Discharge in Insulin-Treated Type 2 Diabetes: A Randomized Pilot Study of Daily Remote Glucose Monitoring

ObjectiveLittle is known about glycemic control in type 2 diabetes patients treated with insulin in the high-risk period between hospital discharge and follow-up. We sought to assess the impact of remote glucose monitoring on postdischarge glycemic control and insulin titration.MethodsWe randomly assigned 28 hospitalized type 2 diabetes patients who were discharged home on insulin therapy to routine specialty care (RSC) or RSC with daily remote glucose monitoring (RGM). We compared the primary outcome of mean blood glucose and exploratory outcomes of hypoglycemia/hyperglycemia rates, change in hemoglobin A_1c and glycated albumin, and insulin titration frequency between groups.ResultsMean blood glucose was not significantly different between the treatment arms (144 ± 34 mg/dL in the RSC group and 172 ± 41 mg/dL in the RGM group; not significant), nor were there significant differences in any of the other measures of glycemia during the month after discharge. Hypoglycemia (glucometer reading < 60 mg/dL) was common, occurring in 46% of subjects, with no difference between groups. In as-treated analysis, insulin dose adjustments (29% with an increase and 43% with decrease in insulin dose) occurred more frequently in the patients who used RGM (average of 2.8 vs. 1.2 dose adjustments; P = .03).ConclusionIn this pilot trial in insulin-treated type 2 diabetes, RGM did not affect glycemic control after hospital discharge; however, the high rate of hypoglycemia in the postdischarge transition period and the higher frequency of insulin titration in patients who used RGM suggest a safety role for such monitoring in the transition from hospital to home. (Endocr Pract. 2015;21:115-121)     

Clinical Characteristics of Patients with Type 2 Diabetes Mellitus Continued on Oral Antidiabetes Medications in the Hospital

Objective: Basal/basal-bolus insulin with discontinuation of home oral antidiabetes medications (OADs) is the preferred method to achieve glycemic control in many hospitalized patients. We hypothesized that a subset of patients with type 2 diabetes mellitus (T2DM) can achieve an acceptable level of blood sugar control without cessation of their OADs when hospitalized.Methods: A retrospective chart review was conducted on patients with T2DM who were only on OADs at home, admitted to Fairview Hospital, a community hospital in the Cleveland Clinic Health System. We divided patients into those whose OADs were continued (group 1) and those whose OADs were discontinued (group 2), with or without the addition of insulin in the hospital. Blood glucose (BG) levels and patient characteristics were compared.Results: There were 175 patients, 73 in group 1 and 102 in group 2. The percentage of patients achieving all BG values within 100 to 180 mg/dL was the same between group 1 (21.9%) and group 2 (23.8%) (P = .78). Mean BG was similar between group 1 and group 2 (146.1 ± 41.4 mg/dL versus 152.1 ± 38.9 mg/dL; P = .33), with no significant difference in terms of percentage of patients with hyperglycemia or hypoglycemia. A greater proportion of patients in group 1 had an uninterrupted feeding status, nonintensive care unit admission and no contrast dye exposure, and a shorter length of stay.Conclusion: Our study shows that patients with certain characteristics could achieve an acceptable level of glycemic control without cessation of their home OADs.Abbreviations: BG = blood glucose; DPP-4 = dipeptidyl dipeptidase 4; GFR = glomerular filtration rate; HbA1c = hemoglobin A1c; ICU = intensive care unit; LOS = length of stay; NPO = nil per os; OAD = oral antidiabetes medication; POC = point of care; T2DM = type 2 diabetes mellitus     

Daily Inpatient Glycemic Survey (DINGS): A Process to Remotely Identify and Assist in the Management of Hospitalized Patients with Diabetes and Hyperglycemia

Objective: Hyperglycemia, hypoglycemia, and glycemic variability have been associated with increased morbidity, mortality, and overall costs of care in hospitalized patients. At the Stratton VA Medical Center in Albany, New York, a process aimed to improve inpatient glycemic control by remotely assisting primary care teams in the management of hyperglycemia and diabetes was designed.Methods: An electronic query comprised of hospitalized patients with glucose values <70 mg/dL or >350 mg/dL is generated daily. Electronic medical records (EMRs) are individually reviewed by diabetes specialist providers, and management recommendations are sent to primary care teams when applicable. Glucose data was retrospectively examined before and after the establishment of the daily inpatient glycemic survey (DINGS) process, and rates of hyperglycemia and hypoglycemia were compared.Results: Patient-day mean glucose slightly but significantly decreased from 177.6 ± 64.4 to 173.2 ± 59.4 mg/dL (P<.001). The percentage of patient-days with any value >350 mg/dL also decreased from 9.69 to 7.36% (P<.001), while the percentage of patient-days with mean glucose values in the range of 90 to 180 mg/dL increased from 58.1 to 61.4% (P<.001). Glycemic variability, assessed by the SD of glucose, significantly decreased from 53.9 to 49.8 mg/dL (P<.001). Moreover, rates of hypoglycemia (<70 mg/dL) decreased significantly by 41% (P<.001).Conclusion: Quality metrics of inpatient glycemic control improved significantly after the establishment of the DINGS process within our facility. Prospective controlled studies are needed to confirm a causal association.Abbreviations: DINGS = daily inpatient glycemic survey EMR = electronic medical record HbA1c = glycated hemoglobin ICU = intensive care unit VA = Veterans Affairs     

Inpatient Glycemic Control on the Vascular Surgery Service

ObjectiveTo describe a structured inpatient insulin management protocol and order set for glycemic control on a vascular surgery service.MethodsPatients admitted to the vascular surgery service with underlying diabetes were enrolled in a study of use of a preprinted basal-bolus insulin order set based on a total daily dose of 0.5 U/kg (0.25 U/kg of insulin glargine and 0.25 U/kg of insulin aspart divided into 3 equal mealtime doses). Outcomes included the mean glycemic control at each of 5 established time intervals, the percentage of blood glucose measurements within the target range of 70 to 180 mg/dL, the incidence of hypoglycemia, and the insulin dosages. Historical control patients with diabetes from the same hospital service were used for comparison.ResultsBoth the study group and the control group consisted of 26 patients. The number of finger-stick blood glucose measurements performed was 871 in the control group and 896 in the intervention group. The mean blood glucose level (± SD) for the intervention group was 149.4 ± 50.7 mg/dL, in comparison with 165.2 ± 64.4 mg/dL for the control group. The incidence of hypoglycemia decreased 50% in the intervention group—from 32 (4% of the finger-stick assessments in the control group) to 19 (2% of the finger-stick blood glucose measurements in the study group). The blood glucose target range of 70 to 180 mg/dL was achieved in 75% of the measurements in the study group versus 61% in the control group. The basal insulin dose was unchanged in 65% of the patients, and of the 9 patients requiring a change in the dose, 5 had the dose decreased by 10% and 4 had the dose increased by 10%.ConclusionThe use of a standardized basal-bolus weight-based insulin regimen was successful at achieving improved glycemic control as well as reducing the incidence of hypoglycemia in an inpatient population with diabetes. (Endocr Pract. 2008;14:185-192)