Basal-Bolus Regimen With Insulin Analogues Versus Human Insulin in Medical Patients with type 2 Diabetes: A Randomized Controlled Trial in Latin America

Objective: Few randomized studies have focused on the optimal management of non–intensive care unit patients with type 2 diabetes in Latin America. We compared the safety and efficacy of a basal-bolus regimen with analogues and human insulins in general medicine patients admitted to a University Hospital in Asunción, Paraguay.Methods: In a prospective, open-label trial, we randomized 134 nonsurgical patients with blood glucose (BG) between 140 and 400 mg/dL to a basal-bolus regimen with glargine once daily and glulisine before meals (n = 66) or Neutral Protamine Hagedorn (NPH) twice daily and regular insulin before meals (n = 68). Major outcomes included differences in daily BG levels and frequency of hypoglycemic events between treatment groups.Results: There were no differences in the mean daily BG (157 ± 37 mg/dL versus 158 ± 44 mg/dL; P = .90) or in the number of BG readings within target <140 mg/dL before meals (76% versus 74%) between the glargine/glulisine and NPH/regular regimens. The mean insulin dose in the glargine/glulisine group was 0.76 ± 0.3 units/kg/day (glargine, 22 ± 9 units/day; glulisine, 31 ± 12 units/day) and was not different compared with NPH/regular group (0.75 ± 0.3 units/kg/day [NPH, 28 ± 12 units/day; regular, 23 ± 9 units/day]). The overall prevalence of hypoglycemia (<70 mg/dL) was similar between patients treated with NPH/regular and glargine/glulisine (38% versus 35%; P = .68), but more patients treated with human insulin had severe (<40 mg/dL) hypoglycemia (7.6% versus 25%; P = .08). There were no differences in length of hospital stay or mortality between groups.Conclusion: The basal-bolus regimen with insulin analogues resulted in equivalent glycemic control and frequency of hypoglycemia compared to treatment with human insulin in hospitalized patients with diabetes.Abbreviations: BG = blood glucose BMI = body mass index HbA_1c = glycated hemoglobin NPH = Neutral Protamine Hagedorn T2D = type 2 diabetes     

Comparison of the Effect of Insulin Glulisine to Insulin Aspart on Breakfast Postprandial Blood Glucose Levels in Children with Type 1 Diabetes Mellitus on Multiple Daily Injections

ObjectiveRapid-acting insulins, including insulin aspart (NovoLog) and lispro (Humalog), do not seem to effectively control postprandial glycemic excursions in children with type 1 diabetes mellitus (T1DM). The objective of this study was to determine if insulin glulisine (Apidra), another rapid-acting insulin analog, would be superior in controlling postprandial hyperglycemia in children with T1DM.MethodsThirteen prepubertal children ages 4 to 11 years completed this study. Inclusion criteria included T1DM ≥6 months, glycosylated hemoglobin (HbAlC) 6.9 to 10%, blood glucose (BG) levels in adequate control for 1 week prior to study start, multiple daily injections (MDI) with insulin glargine or determir once daily and aspart or lispro premeal. If fasting BG was 70 to 180 mg/dL, subjects received insulin glulisine alternating with aspart prior to a prescribed breakfast with a fixed amount of carbohydrate (45, 60, or 75 g) for 20 days. Postprandial BG values were obtained at 2 and 4 hours.ResultsMean baseline BG values for insulin glulisine (136.4 ± 15.7 mg/dL; mean ± SD) and aspart (133.4 ± 14.7 mg/dL) were similar (P = .34). Mean increase in 2-hour postprandial BG was higher in glulisine (+113.5 ± 65.2 mg/dL) than aspart (+98.6 ± 66.9 mg/dL), (P = .01). BG remained higher at 4 hours (glulisine: 141.9 ± 36.5 mg/ dL, aspart: 129.0 ± 37.0 mg/dL) (P = .04). Although statistically insignificant, more hypoglycemic events occurred at 2-and 4-hours postprandial with insulin aspart.ConclusionInsulin aspart appears to be more effective than insulin glulisine in controlling 2-and 4-hour postprandial BG excursions in prepubertal children with T1DM. (Endocr Pract. 2013;19:614-619)     

Safety And Efficacy Of Dpp-4 Inhibitors For The Management Of Hospitalized General Medicine And Surgery Patients with Type 2 Diabetes

Objective: DPP-4 inhibitors (DPP-4i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from 3 prospective studies using DPP-4i in general medicine and surgery patients with type 2 diabetes (T2D).Methods: We combined data from 3 randomized studies comparing DPP-4i alone or in combination with basal insulin or a basal-bolus insulin regimen. Medicine (n = 266) and surgery (n = 319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dL, treated with diet, oral agents, or low-dose insulin therapy were included. Patients received DPP-4i alone (n = 144), DPP-4i plus basal insulin (n = 158) or basal-bolus regimen (n = 283). All groups received correctional doses with rapid-acting insulin for BG >140 mg/dL. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications.Results: There were no differences in mean hospital daily BG among patients treated with DPP-4i alone (170 ± 37 mg/dL), DPP-4i plus basal (172 ± 42 mg/dL), or basalbolus (172 ± 43 mg/dL), P = .94; or in the percentage of BG readings within target of 70 to 180 mg/dL (63 ± 32%, 60 ± 31%, and 64 ± 28%, respectively; P = .42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP-4i alone (2%) compared to DPP-4i plus basal (9%) and basal-bolus (10%); P = .004.Conclusion: Treatment with DPP-4i alone or in combination with basal insulin is effective and results in a lower incidence of hypoglycemia compared to a basal-bolus insulin regimen in general medicine and surgery patients with T2D.Abbreviations: BG = blood glucose; BMI = body mass index; CI = confidence interval; DPP-4i = dipeptidyl peptidase-4 inhibitors; HbA1c = hemoglobin A1c; OR = odds ratio; T2D = type 2 diabetes     

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     

Glucose Variability is an Independent Predictor of Mortality in Hospitalized Patients Treated with Total Parenteral Nutrition

ObjectiveHyperglycemia is associated with increased mortality in critically ill patients treated with total parenteral nutrition (TPN). The role of glucose variability (GV) in predicting outcomes in these patients is not known.MethodsThis retrospective study included medical and surgical patients receiving TPN in a community teaching hospital. GV was calculated by standard deviation (SD) of blood glucose (BG) values and by mean BG daily (Δ) change (daily max – daily minimum).ResultsA total of 276 medical and surgical patients (mean age: 51 ± 18 years), 19% with a history of diabetes mellitus (DM), and 74% with intensive care unit (ICU) admission were treated with TPN. During TPN, the mean daily BG was 142.9 ± 33 mg/dL; frequencies of hypoglycemia < 70 and < 40 mg/dL were 41% and 3%, respectively; and hospital mortality was 27.2%. The mean GV by SD was 38 ± 21 mg/dL and by mean (Δ) change 58 ± 34 mg/dL. GV was significantly higher in deceased patients (SD: 48 ± 25 vs. 34 ± 18 mg/dL and Δ change: 75 ± 39 vs. 51 ± 29 mg/dL, both P < .01) than surviving patients. Multivariate analysis adjusted for age, DM status, gender, APACHE (Acute Physiology and Chronic Health Evaluation) score, mean daily glucose, and hypoglycemia revealed that GV was an independent predictor of hospital mortality (P < .05). The association between GV and mortality was limited to patients without a history of DM and was not present in patients with DM.ConclusionHigh GV is associated with increased hospital mortality independent of the presence and severity of hyperglycemia or hypoglycemia during TPN therapy. Prospective randomized trials are needed to determine if reduction in GV with intensive glycemic control improves clinical outcomes in patients treated with TPN. (Endocr Pract. 2014;20:41-45)     

Management of Hyperglycemia in Diabetic Patients with Hematologic Malignancies During Dexamethasone Therapy

ObjectiveTo compare the response to different insulin regimens for management of hyperglycemia in diabetic patients with hematologic malignancies who are receiving dexamethasone.MethodsA retrospective analysis was conducted to determine whether a basal bolus insulin (BBI) regimen with detemir and aspart is superior to a sliding scale regular insulin (SSI) regimen for management of hyperglycemia in hospitalized diabetic patients receiving dexamethasone.ResultsForty patients with hematologic malignancies were treated with intravenous (8 to 12 mg/day) or oral (40 mg/day) dexamethasone for 3 days. The average blood glucose (BG) level was 301 ± 57 mg/dL in the SSI group (n = 28) and 219 ± 51 mg/dL in the BBI group (n = 12) (P <.001). The BBI regimen resulted in an average BG reduction of 52 ± 82 mg/dL throughout the course of dexa-methasone therapy, while the SSI regimen produced an increase in the mean daily BG level of 128 ± 77 mg/dL (P <.001). On the last day of dexamethasone administration, the insulin requirement was 49 ± 29 units/day in the SSI group and 122 ± 39 units/day in the BBI group (P <.001). Three patients in the SSI group developed diabetic ketoacidosis or hyperosmolar hyperglycemia during steroid therapy. No hypoglycemia was observed in either group. The length of stay and infection rates were similar between groups.ConclusionBasal and bolus insulin regimen is an effective and safe approach for managing dexamethasone-induced hyperglycemia in hospitalized patients with hematologic malignancies. (Endocr Pract. 2013;19:231-235)     

Examination of Implementation of Intravenous and Subcutaneous Insulin Protocols and Glycemic Control in Heart Transplant Patients

ObjectivePerioperative glycemic management is particularly challenging in heart transplant (HT) patients who are on high-dose steroids and subject to surgical stress. The objective of the study was to examine the efficacy and safety of perioperative insulin administration in HT patients with and without diabetes.MethodsMedical records of 71 HT patients from June 1, 2005 to July 31, 2009 whose hyperglycemia was managed by our Glucose Management Service (GMS) were analyzed for up to 1 year after HT. Their daily blood glucose (BG) averages on intravenous (IV) insulin drips and subcutaneous (SQ) insulin, hypoglycemia rates, reasons for hypoglycemia, and deviations from insulin protocols were analyzed.ResultsDaily BG averages between diabetic (DM) and nondiabetic (nonDM) patients were not significantly different while on the drip but were significantly different for first 5 days on SQ (P < .05). The daily insulin glargine doses were similar. No patients developed severe hypoglycemia (BG ≤ 40 mg/dL) while on drip, and only 2.8% experienced hypoglycemia on SQ. Among 40 episodes of moderate hypoglycemia while on drip, 15 had nurse deviations from protocol prior to the episode. Posttransition day fasting glucose was at goal (mean 124.7 ± 35.4 mg/dL); however 39.4% (28/71) of patients received a transition insulin glargine dose that was different from the amount indicated by protocol. The likelihood of developing moderate hypoglycemia on SQ was associated with the glargine dose used at the time of transition (odds ratio [OR] 1.03, P = .034).ConclusionInpatient insulin protocols implemented by a GMS are successful in obtaining glycemic control with minimal side effects in patients with and without diabetes, even when they are on a high-dose steroid regimen. (Endocr Pract. 2014;20:527-535)     

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     

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)     

The Association of Diabetes and Hyperglycemia on Inpatient Readmissions

ObjectiveTo evaluate the association between inpatient glycemic control and readmission in individuals with diabetes and hyperglycemia (DM/HG).MethodsTwo data sets were analyzed from fiscal years 2011 to 2013: hospital data using the International Classification of Diseases, Ninth Revision (ICD-9) codes for DM/HG and point of care (POC) glucose monitoring. The variables analyzed included gender, age, mean, minimum and maximum glucose, along with 4 measures of glycemic variability (GV), standard deviation, coefficient of variation, mean amplitude of glucose excursions, and average daily risk range.ResultsOf 66 518 discharges in FY 2011-2013, 28.4% had DM/HG based on ICD-9 codes and 53% received POC monitoring. The overall readmission rate was 13.9%, although the rates for individuals with DM/HG were higher at 18.9% and 20.6% using ICD-9 codes and POC data, respectively. The readmitted group had higher mean glucose (169 ± 47 mg/dL vs 158 ± 46 mg/dL, P < .001). Individuals with severe hypoglycemia and hyperglycemia had the highest readmission rates. All 4 GV measures were consistent and higher in the readmitted group.ConclusionIndividuals with DM/HG have higher 30-day readmission rates than those without. Those readmitted had higher mean glucose, more extreme glucose values, and higher GV. To our knowledge, this is the first report of multiple metrics of inpatient glycemic control, including GV, and their associations with readmission.     

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)     

Hospital Insulin Protocol Aims For Glucose Control In Glucocorticoid-Induced Hyperglycemia

Objective: To compare the effectiveness of 2 insulin protocols to treat glucocorticoid-induced hyperglycemia in the nonintensive care hospital setting.Methods: A randomized, open-label, parallel-arm study was conducted comparing standard recommended care of complete insulin orders (CIO) (i.e., 3-part insulin regimen of long-acting basal [background], rapid-acting bolus [mealtime], and rapid-acting correction factor) to an experimental group following a regimen of Neutral Protamine Hagedorn (NPH) plus CIO (NPH-CIO). The primary outcome was mean blood glucose (BG), and the secondary outcome was percent of BG in target range of 70 to 180 mg/dL. Hypoglycemia was also evaluated.Results: Sixty-one patients completed 2 to 5 consecutive inpatient days (31 CIO; 30 NPH-CIO). Baseline mean BG results were 237.2 ± 50.2 and 221.9 ± 35.8 mg/dL (P = .30) in the CIO and NPH-CIO groups, respectively. No significant difference in overall mean BG between the 2 groups was detected; however, a significant difference arose on day 3: mean BG 181.8 ± 32.6 mg/dL (CIO) versus 157.2 ± 6.1 mg/dL (NPH-CIO) (P = .03). Moreover, the total daily doses (TDDs) of insulin did not differ: 34.8 ± 43.0 units (CIO) versus 35.8 ± 25.0 units (NPH-CIO) (P = .13). Percent of BG in target was 54.6% (CIO) and 62% (NPH-CIO) (P = .24). Incidence of severe hypoglycemia (<50 mg/dL) was the same in both groups (0.1%).Conclusion: NPH added to 3-part insulin regimen (CIO) may be an effective way to a combat glucocorticoid-induced hyperglycemia, though further research is needed in a larger population.Abbreviations:A1C = hemoglobin A1CBG = blood glucoseCIO = complete insulin ordersDM = diabetes mellitusNPH = neutral protamine HagedornNPH-CIO = neutral protamine Hagedorn plus CIOTDD = total daily dose     

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)     

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     

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)     

Impact of a Hypoglycemia Reduction Bundle and a Systems Approach to Inpatient Glycemic Management

Objective: Uncontrolled hyperglycemia and iatrogenic hypoglycemia represent common and frequently preventable quality and safety issues. We sought to demonstrate the effectiveness of a hypoglycemia reduction bundle, proactive surveillance of glycemic outliers, and an interdisciplinary data-driven approach to glycemic management.Methods: Population: all hospitalized adult non–intensive care unit (non-ICU) patients with hyperglycemia and/or a diagnosis of diabetes admitted to our 550-bed academic center across 5 calendar years (CYs). Interventions: hypoglycemia reduction bundle targeting most common remediable contributors to iatrogenic hypoglycemia; clinical decision support in standardized order sets and glucose management pages; measure-vention (daily measurement of glycemic outliers with concurrent intervention by the inpatient diabetes team); educational programs. Measures and analysis: Pearson chi-square value with relative risks (RRs) and 95% confidence intervals (CIs) were calculated to compare glycemic control, hypoglycemia, and hypoglycemia management parameters across the baseline time period (TP1, CY 2009–2010), transitional (TP2, CY 2011–2012), and mature postintervention phase (TP3, CY 2013). Hypoglycemia defined as blood glucose <70 mg/dL, severe hypoglycemia as <40 mg/dL, and severe hyperglycemia >299 mg/dL.Results: A total of 22,990 non-ICU patients, representing 94,900 patient-days of observation were included over the 5-year study. The RR TP3:TP1 for glycemic excursions was reduced significantly: hypoglycemic stay, 0.71 (95% CI, 0.65 to 0.79); severe hypoglycemic stay, 0.44 (95% CI, 0.34 to 0.58); recurrent hypoglycemic day during stay, 0.78 (95% CI, 0.64 to 0.94); severe hypoglycemic day, 0.48 (95% CI, 0.37 to 0.62); severe hyperglycemic day (>299 mg/dL), 0.76 (95% CI, 0.73 to 0.80).Conclusion: Hyperglycemia and hypoglycemia event rates were both improved, with the most marked effect on severe hypoglycemic events. Most of these interventions should be portable to other hospitals.Abbreviations: BG = blood glucose CDS = clinical decision support CI = confidence interval CY = calendar year DIG = diabetes initiative group EHR = electronic health record ICU = intensive care unit RR = relative risk SHM = Society of Hospital Medicine TP = time period     

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     

Effectiveness of Inpatient Insulin Order Sets Using Human Insulins in Noncritically Ill Patients in A Rural Hospital

Objective: Recent guidelines recommend a physiologic approach to non–intensive care unit (ICU) inpatient glucose management utilizing basal-bolus with correctional (BBC) insulin over traditional sliding-scale insulin monotherapy. Unfortunately, few studies exist using a BBC approach restricted to human insulins (regular and neutral protamine Hagedorn [NPH]). This study evaluated changes in provider prescribing patterns, effects on blood glucose, and safety with implementation of hospital order sets for BBC using human insulins.Methods: Order sets were developed for non-ICU inpatients, consisting of basal, prandial, and correctional insulin using NPH and regular human insulins. Evaluation compared a 4-month period before (admissions, n = 274) with a 4-month period after order set availability (n = 302). Primary outcome was change in insulin prescribing patterns. Secondary outcomes included use of nonpreferred diabetes treatments, hemoglobin A_1c testing, mean daily blood glucose, and incidence of hypoglycemia.Results: Use of BBC insulin regimen increased from 10.6 to 27.5% after order set implementation (P<.001). Use of oral antihyperglycemic agents decreased from 24.1 to 14.9% after implementation (P = .006). Hemoglobin A_1c testing rose from 50.0 to 62.3% after (P = .003). Mean daily blood glucose improved, with an estimated mean difference of 14.4 mg/dL (95% confidence interval, 2.2 to 26.5 mg/dL) over hospital days 3 through 9 (P = .02). There was no significant change in the incidence of moderate or severe hypoglycemia.Conclusion: Implementation of hospital-wide human insulin order sets led to improvements in prescribing practices and blood glucose control, without increasing the incidence of hypoglycemia. These order sets may be useful for facilities limited by formulary and cost considerations to the use of older human insulins.Abbreviations: BBC = basal-bolus with correctional insulin ICU = intensive care unit NPH = neutral protamine Hagedorn NPO = nil per os     

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     

U500 Regular Insulin use in Insulin-Resistant type 2 Diabetic Veteran Patients

ObjectiveTo evaluate the use of U500 regular insulin therapy in insulin-resistant patients with type 2 diabetes mellitus who were previously treated with high-dosage U100 insulin regimens.Methods:At a large Veterans Affairs medical center, a retrospective chart review was performed of all patients whose U100 insulin regimens were converted to U500 regular insulin regimens using a protocol to ensure patient safety. Patients were followed up for longer than 6 months. Data reviewed included total daily dosage of insulin before and after regimen conversion and changes in hemoglobin A1c, body weight, lipids, and episodes of severe hypoglycemia.ResultsFifty-three patients met inclusion criteria. Average hemoglobin A1c level on U100 insulin regimens was 9.1 ± 1.7%, which decreased to 8.1 ± 1.3% (P < .001) after an average of 20 months (range, 6-52 months) on U500 insulin. The total daily insulin dosage at study end was not significantly greater on U500 (415 ± 166 units/day) than on U100 insulin (391 ± 120 units/day) (P = .34). Body weight did not change significantly (134 ± 29 kg vs 136 ± 30 kg, P = .18). There was a 20-mg/dL decrease in total cholesterol (P = .014). Triglyceride values decreased by 97 mg/dL (P = .005). Eight episodes of severe hypoglycemia were documented in patients treated with U500 insulin, but this was similar to the incidence in these same patients while treated with U100 insulin.ConclusionWe conclude that U500 insulin can be safely and effectively used in insulin-resistant patients with type 2 diabetes followed up at a large Veterans Affairs medical center using a protocol that ensures patients are thoroughly educated and carefully monitored. (Endocr Pract. 2012;18:34-38)