Automated Insulin Delivery Technology In The Hospital: Update on Safety and Efficacy Data.

BACKGROUND: Automated insulin delivery systems (AID) are a rapidly growing component in the area of continuous subcutaneous insulin infusion (CSII) therapy. As more patients use these systems in the outpatient setting, it is important to assess safety if their use is allowed to continue in the inpatient setting. METHODS: Analysis was conducted of the records of patients using AID technology upon admission to our hospital between June 2020 and December 2022. Adverse events and glycemic control of AID users were compared to patients using non-AID systems and to patients who had CSII discontinued. RESULTS: There were 185 patients analyzed: 64 on AID, 86 on non-AID, and 35 who had CSII discontinued. The number of patients on AID increased over the course of the observation period, while non-AID users decreased. Pair-wise comparisons indicated that patient-stay mean glucose levels and percentage of hypoglycemic events were similar between all groups, but the percentage of patient hyperglycemic measurements was significantly lower in the AID cohort. No adverse events (diabetic ketoacidosis, pump site complications, equipment malfunction) were reported in any either CSII cohort. CONCLUSION: The type of CSII technology encountered in the hospital is shifting from non-AID towards AID technologies. This analysis supports earlier findings that outpatient AID systems can be successfully transitioned into the inpatient setting. Further study is needed to define if AID systems offer any advantage in glycemic control.

Assessing outcomes of intravenous insulin therapy in non-intensive care patients.

OBJECTIVES: The aim of this study was to compare outcomes of using intravenous insulin infusion (IVII) therapy for managing hyperglycemia in a non-intensive care unit (ICU) versus an ICU setting. METHODS: We conducted a retrospective analysis on patients who received IVII for hyperglycemia. The analysis compared variables associated with hypoglycemic events while on IVII, and point-of-care blood glucose control and insulin regimens at discharge. Insulin administration errors occurring on IVII were determined. RESULTS: Between November 2020 and August 2022, 881 patients received 1,106 IVIIs (780 in ICU and 326 non-ICU). A cumulative 468 days were spent on IVII in the non-ICU setting and 1564 in the ICU (total 2,032 days). The frequency of hypoglycemia on IVII was higher when provided in the non-ICU vs ICU (1.4% vs 0.7%), p < 0.01). Non-ICU patients had significantly higher average blood glucose during the last 24 h of the hospital stay (185 mg/dL vs 160 mg/dL, non-ICU vs. ICU, Pp < 0.01) and were more likely discharged with basal-bolus insulin therapy (p < 0.01). After adjusting for other variables, the probability of having hypoglycemia (OR 2.35; 95% CI 1.62-3.42; p < 0.001) was higher for the non-ICU cohort. In addition, patients who received IVII in the non-ICU settings had mean glucose levels nearly 26 mg/dL higher (95% CI 19.40-32.9, p < 0.001) at discharge vs. ICU. Seven cases of insulin errors were reported while on IVII in the non-ICU settings, compared to one in the ICU. CONCLUSIONS: A large number (468) of ICU days were avoided by providing IVII in the non-ICU setting. Of the more than 400 days of IVII therapy provided in the non-ICU, only 7 medication errors occurred. Further studies are needed to optimize IVII strategy for non-ICU patients.

Diabetes mellitus and blood glucose variability increases the 30-day readmission rate after kidney transplantation.

INTRODUCTION: Inpatient hyperglycemia is an established independent risk factor among several patient cohorts for hospital readmission. This has not been studied after kidney transplantation. Nearly one-third of patients who have undergone a kidney transplant reportedly experience 30-day readmission. METHODS: Data on first-time solitary kidney transplantations were retrieved between September 2015 and December 2018. Information was linked to the electronic health records to determine diagnosis of diabetes mellitus and extract glucometric and insulin therapy data. Univariate logistic regression analysis and the XGBoost algorithm were used to predict 30-day readmission. We report the average performance of the models on the testing set on bootstrapped partitions of the data to ensure statistical significance. RESULTS: The cohort included 1036 patients who received kidney transplantation; 224 (22%) experienced 30-day readmission. The machine learning algorithm was able to predict 30-day readmission with an average area under the receiver operator curve (AUC) of 78% with (76.1%, 79.9%) 95% confidence interval (CI). We observed statistically significant differences in the presence of pretransplant diabetes, inpatient-hyperglycemia, inpatient-hypoglycemia, minimum and maximum glucose values among those with higher 30-day readmission rates. The XGBoost model identified the index admission length of stay, presence of hyper- and hypoglycemia, the recipient and donor body mass index (BMI) values, presence of delayed graft function, and African American race as the most predictive risk factors of 30-day readmission. Additionally, significant variations in the therapeutic management of blood glucose by providers were observed. CONCLUSIONS: Suboptimal glucose metrics during hospitalization after kidney transplantation are associated with an increased risk for 30-day hospital readmission. Optimizing hospital blood glucose management, a modifiable factor, after kidney transplantation may reduce the risk of 30-day readmission.

A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials.

Diabetes Technology Society organized an expert consensus panel to develop metrics for research in the use of continuous glucose monitors (CGMs) in a hospital setting. The experts met virtually in small groups both before and after an April 13, 2023 virtual meeting of the entire panel. The goal of the panel was to develop consensus definitions in anticipation of greater use of CGMs in hospital settings in the future. Establishment of consensus definitions of inpatient analytical metrics will be easier to compare outcomes between studies. Panelists defined terms related to 10 dimensions of measurements related to the use of CGMs including (1) hospital hypoglycemia, (2) hospital hyperglycemia, (3) hospital time in range, (4) hospital glycemic variability, (5) hospital glycemia risk index, (6) accuracy of CGM devices and reference methods for CGMs in the hospital, (7) meaningful time blocks for hospital glycemic goals, (8) hospital CGM data sufficiency, (9) using CGM data for insulin dosing, and (10) miscellaneous factors. The panelists voted on 51 proposed recommendations. Based on the panel vote, 51 recommendations were classified as either strong (43) or mild (8). Additional research is needed on CGM performance in the hospital. This consensus report is intended to support that type of research intended to improve outcomes for hospitalized people with diabetes.

Glucometrics: Where Are We Now?

PURPOSE OF REVIEW: Inpatient glucose data analysis, or glucometrics, has developed alongside the growing emphasis on glycemic control in the hospital. Shortcomings in the initial capabilities for glucometrics have pushed advancements in defining meaningful units of measurement and methods for capturing glucose data. This review addresses the growth in glucometrics and ends with its promising new state. RECENT FINDINGS: Standardization, allowing for benchmarking and purposeful comparison, has been a goal of the field. The National Quality Foundation glycemic measures and recently enacted Center for Medicare and Medicaid Services (CMS) electronic quality measures for hypo- and hyperglycemia have allowed for improved integration and consistency. Prior systems have culminated in an upcoming measure from the Center for Disease Control and Prevention's National Healthcare Safety Network. It is poised to create a new gold standard for glucometrics by expanding and refining the CMS metrics, which should empower both local improvement and benchmarking as the program matures.

Hybrid Closed-Loop Insulin Pump Technology Can Be Safely Used in the Inpatient Setting.

BACKGROUND: Hybrid closed-loop (HCL) systems, also known as automated insulin delivery systems, are a rapidly growing technology in diabetes management. Because more patients are using these systems in the outpatient setting, it is important to also assess inpatient safety to determine whether HCL use can be continued when those patients become hospitalized. METHODS: The records of patients using HCL technology on admission to our hospital between June 1, 2020, and June 30, 2021, were analyzed. RESULTS: The final analysis included 71 patients divided into 3 categories based on their pump use as an inpatient: (1) HCL users; (2) manual pump users; and (3) pump removed. All cohorts were similar in age, sex, race, hemoglobin A1C at admission, and in Medicare Severity Diagnosis Related Group. Pairwise comparisons indicated that patient-stay mean glucose levels, frequency of patient-specific hyperglycemic measurements, and frequency of hypoglycemic events were similar between all groups. No adverse events, particularly occurrences of diabetic ketoacidosis, pump site complications or infection, or equipment malfunction, were reported. CONCLUSION: This preliminary case series review indicates that continued use of HCL technology in the hospital is safe. Moreover, glycemic control in HCL users was comparable with that in those using insulin pump with manual settings and those converted to basal-bolus insulin therapy.

A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings.

BACKGROUND: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. METHODS: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. RESULTS: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. CONCLUSION: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Autoimmune polyglandular syndrome type 3: A case report of an unusual presentation and literature review.

Autoimmune polyglandular syndromes (APS) are rare disorders characterized by auto-destruction of endocrine and non-endocrine organs by organ-specific antibody-directed T-lymphocytic infiltration. This case highlights a 29-year-old Caucasian man with vitiligo found to have significant neurological abnormalities in the setting of newly diagnosed pernicious anemia and thyroid autoimmune disease.

A Plant-Based Dietary Intervention for Preoperative Glucose Optimization in Diabetic Patients Undergoing Total Joint Arthroplasty.

Purpose. The purpose of this study was to assess the feasibility and effectiveness of a whole food plant-based diet (WFPBD) to improve day of surgery fasting blood glucose (FBG) among patients with type 2 diabetes (T2D). Patients and Methods. Ten patients with T2D scheduled for a total hip or total knee replacement were recruited. For 3 weeks preceding their surgeries, subjects were asked to consume an entirely WFPBD. Frozen WFPBD meals were professionally prepared and delivered to each participant for the 3 weeks prior to surgery. FBG was reassessed on the morning of surgery and compared with preintervention values. Compliance with the diet was assessed. Results. Mean age of subjects and reported duration of diabetes was 65 and 8 years, respectively, average hemoglobin A1c (HbA1c) was 6.6%, and 6 were women. Mean FBG decreased from 127 to 116 mg/dL (P = .2). Five of the subjects experienced improvement in glycemic control, with an average decline of 11 mg/dL. Conclusion. A WFPBD is a potentially effective intervention to improve glycemic control among patients with T2D during the period leading up to surgery. Future controlled trials on a larger sample of patients to assess the impact of a WFPBD on glycemic control and surgical outcomes are warranted.

Unsafe Sharps Disposal Among Insulin-Using Patients With Diabetes Mellitus: An Emerging Global Crisis.

Approximately eight billion therapeutic injections are administered outside of medical treatment facilities annually. The management of diabetes mellitus (DM) includes self-monitoring of blood glucose levels and administration of insulin and injectable non-insulin-related medications. The lancets, needles, and syringes used for DM management are categorized as medical sharps. Improperly discarded medical sharps can cause needlestick injuries in unsuspecting individuals and thereby pose a considerable public health risk. Release of these items into the environment will likely increase with the rising worldwide prevalence of DM, and a public safety crisis will emerge if proper disposal measures are not emphasized. This article reviews the literature from various geopolitical regions and describes how a substantial number of patients with DM improperly discard their sharps. Data support the need to develop multifaceted and innovative approaches to reduce risk associated with improper disposal of DM-related medical sharps into local communities.

Cancer, diabetes, survival and glycemic control: a large multisite analysis.

Aim: To determine overall survival (OS) and glycemic control in patients with cancer and diabetes. Materials & methods: Patients of our institution with breast, colon, lung, pancreas and prostate cancer were retrospectively reviewed. OS was compared between matched patients with and without diabetes, and changes in glucose value over time were assessed. Results: For 3934 patients each with and without diabetes, adjusted analysis showed no difference in OS according to diabetes status (hazard ratio: 1.07; 95% CI: 0.96-1.20). Mean glucose values decreased over time in patients with and without diabetes (p = 0.01). Conclusion: In this large study of patients with five common cancers, the co-occurrence of diabetes did not affect OS. Cancer did not adversely affect glucose levels.

The aim of this study was to evaluate survival and glucose control in patients with cancer and diabetes at three separate geographic locations in a single health system. From an institutional cancer registry, we identified patients with breast, colon, lung, pancreas and prostate cancers. Patients with and without diabetes were matched by age, sex, cancer type, staging, geographic location and year of cancer diagnosis. In this study, the co-occurrence of diabetes did not affect overall survival. Cancer did not adversely affect glucose levels.

Use of Cross-sectional and Perspective Mapping to Spatially and Statistically Represent Inpatient Glucose Control.

BACKGROUND: The use of inpatient location for the depiction of glycemic control is an alternative approach to the traditional analysis of hospital-derived glucometric data. Our aim was to develop a method of spatial representation and to test for corresponding statistical variation in inpatient glucose control data. METHODS: Point-of-care blood glucose data from inpatients with diabetes mellitus were extracted. Calculations included patient-day weighted means (PDWMs) and percentage of patient hospital days with hypoglycemia. Results were overlaid onto hospital floor plans, and room numbers were used as geolocators to generate cross-sectional (2-dimensional) and perspective (3-dimensional) views of the data. Linear mixed and mixed-effects logistic regression models were used to compare the location effect and to assess statistical variation in the data after adjusting for age, sex, and severity of illness. RESULTS: Visual inspection of cross-sectional and perspective maps demonstrated variation in glucometric outcomes across areas within the hospital. Statistical analysis confirmed significant variation between some hospital wings and floors. CONCLUSIONS: Spatial depiction of glucometric data within the hospital could yield insights into hot spots of poor glycemic control. Future studies on how to operationalize this approach, and whether this method of analysis can drive changes in glycemic management practices, need to be conducted.

Survival and glycemic control in patients with co-existing squamous cell carcinoma and diabetes mellitus.

AIM: This study examined the impact of diabetes mellitus (DM) on survival in squamous cell carcinoma (SCC) patients, and the impact of SCC on glycemic control. MATERIALS & METHODS: Patients with newly diagnosed SCC with and without DM were matched 1:1 (2007-2017). Overall survival and recurrence-free survival were estimated using the Kaplan-Meier method. Hemoglobin A1c (HbA1c) and glucose level during the year following cancer diagnosis were compared using mixed models. RESULTS: HbA1c decreased over time in DM patients (p = 0.04). The 5-year overall survival was 61% in DM patients, compared with 78% in patients without DM (p = 0.004). CONCLUSION: The presence of co-existing DM adversely impacted survival in patients with SCC. SCC did not affect glycemic control.

Implications of neuroendocrine tumor and diabetes mellitus on patient outcomes and care: a matched case-control study.

AIM: We aimed to determine the impact of diabetes mellitus (DM) on survival of patients with neuroendocrine tumors (NETs) and of NETs on glycemic control. PATIENTS & METHODS: Patients with newly diagnosed NETs with/without DM were matched 1:1 by age, sex and diagnosis year (2005-2017), and survival compared (Kaplan-Meier and Cox proportional hazards). Mixed models compared hemoglobin A1c (HbA1c) and glucose during the year after cancer diagnosis. RESULTS: Three-year overall survival was 72% (95% CI: 60-86%) for DM patients versus 80% (95% CI: 70-92%) for non-DM patients (p = 0.82). Hazard ratio was 1.33 (95% CI: 0.56-3.16; p = 0.51); mean DM HbA1c, 7.3%. CONCLUSION: DM did not adversely affect survival of patients with NET. NET and its treatment did not affect glycemic control.

Use of Imputation and Decision Modeling to Improve Diagnosis and Management of Patients at Risk for New-Onset Diabetes After Transplantation.

BACKGROUND New-onset diabetes after transplantation (NODAT) is a complication of solid organ transplantation. We sought to determine the extent to which NODAT goes undiagnosed over the course of 1 year following transplantation, analyze missed or later-diagnosed cases of NODAT due to poor hemoglobin A1c (HbA1c) and fasting blood glucose (FBG) collection, and to estimate the impact that improved NODAT screening metrics may have on long-term outcomes. MATERIAL AND METHODS This was a retrospective study utilizing 3 datasets from a single center on kidney, liver, and heart transplantation patients. Retrospective analysis was supplemented with an imputation procedure to account for missing data and project outcomes under perfect information. In addition, the data were used to inform a simulation model used to estimate life expectancy and cost-effectiveness of a hypothetical intervention. RESULTS Estimates of NODAT incidence increased from 27% to 31% in kidney transplantation patients, from 31% to 40% in liver transplantation patients, and from 45% to 67% in heart transplantation patients, when HbA1c and FBG were assumed to be collected perfectly at all points. Perfect screening for kidney transplantation patients was cost-saving, while perfect screening for liver and heart transplantation patients was cost-effective at a willingness-to-pay threshold of $100 000 per life-year. CONCLUSIONS Improved collection of HbA1c and FBG is a cost-effective method for detecting many additional cases of NODAT within the first year alone. Additional research into both improved glucometric monitoring as well as effective strategies for mitigating NODAT risk will become increasingly important to improve health in this population.

Patterns of Sharps Handling and Disposal Among Insulin-Using Patients With Diabetes Mellitus.

BACKGROUND: The objective of this study was to assess disposal patterns for "sharps" among a cohort of patients with diabetes mellitus (DM) receiving insulin therapy. METHOD: A convenience sample of inpatients and outpatients was surveyed about how they disposed of sharps, how often they reused lancets and needles, and what education they had received about proper disposal. Safe disposal was defined as discarding sharps into a formal sharps or sealable container; otherwise, disposal was categorized as unsafe. RESULTS: Of 150 respondents, 56% were men and 75% were white. The mean (SD) age was 56 (15) years; duration of DM, 20 (13) years; and hemoglobin A1c, 8.1% (2.0%). Half the respondents reused a lancet two or more times, and 21% reused an insulin needle two or more times. Thirty-eight percent of respondents discarded lancets unsafely, and 33% discarded insulin needles unsafely, typically by throwing these items into household trash. Most respondents (75%) discarded insulin pens, vials, cartridges, insulin pump supplies, and continuous glucose monitor sensors into household trash. Most (64%) indicated that they had not received education on safe sharps-disposal practices, and 84% had never visited their municipal website for information on medical waste disposal. CONCLUSION: Approximately one-third of patients unsafely disposed of sharps. Unsafe disposal could cause millions of sharps to appear in the municipal solid waste stream, thereby posing a substantial public health hazard. Point-of-care patient education is important, but a broader public health campaign may be required.

Assessing the relationship between institutional cancer and diabetes mortality rates using National Death Index data.

AIM: To evaluate overall survival (OS), glycemic control in cancer patients with and without diabetes mellitus (DM). PATIENTS & METHODS: Patients (2010-2015) with newly diagnosed prostate, breast, lung, colorectal and pancreatic cancers were identified in institutional cancer registry. Data linked to National Death Index for vital status. 5-year OS estimated; glucose and hemoglobin A1c assessed during year postdiagnosis. RESULTS: We identified 1404 patients (non-DM, n = 936; DM, n = 468). DM cohort had 168 deaths (36%); non-DM, 267 (29%). 5-year OS estimated at 58% (95% CI: 53-64%) for DM and 67% (95% CI: 64-71%) for controls; for matched pairs, hazard ratio: 1.35 (95% CI: 1.02-1.79). Cancer did not harm glycemic control. CONCLUSION: OS among cancer patients with DM was lower than without DM.

Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline.

This article is the work product of the Continuous Glucose Monitor and Automated Insulin Dosing Systems in the Hospital Consensus Guideline Panel, which was organized by Diabetes Technology Society and met virtually on April 23, 2020. The guideline panel consisted of 24 international experts in the use of continuous glucose monitors (CGMs) and automated insulin dosing (AID) systems representing adult endocrinology, pediatric endocrinology, obstetrics and gynecology, advanced practice nursing, diabetes care and education, clinical chemistry, bioengineering, and product liability law. The panelists reviewed the medical literature pertaining to five topics: (1) continuation of home CGMs after hospitalization, (2) initiation of CGMs in the hospital, (3) continuation of AID systems in the hospital, (4) logistics and hands-on care of hospitalized patients using CGMs and AID systems, and (5) data management of CGMs and AID systems in the hospital. The panelists then developed three types of recommendations for each topic, including clinical practice (to use the technology optimally), research (to improve the safety and effectiveness of the technology), and hospital policies (to build an environment for facilitating use of these devices) for each of the five topics. The panelists voted on 78 proposed recommendations. Based on the panel vote, 77 recommendations were classified as either strong or mild. One recommendation failed to reach consensus. Additional research is needed on CGMs and AID systems in the hospital setting regarding device accuracy, practices for deployment, data management, and achievable outcomes. This guideline is intended to support these technologies for the management of hospitalized patients with diabetes.

Nurse adherence to post-hypoglycemic event monitoring for hospitalized patients with diabetes mellitus.

PURPOSE: The aim of this study was to investigate adherence to a posthypoglycemic event-monitoring policy for inpatients with diabetes mellitus receiving insulin therapy. METHODS: We analyzed point-of-care blood glucose data from noncritically ill inpatients receiving insulin therapy who had a hypoglycemic event (<70 mg/dL glucose) from January 3, 2017, through April 7, 2018. Blood glucose was measured until 2 sequential readings showed hypoglycemia resolution. An interval of 10 to 20 min between measurements was defined as compliant with policy. We calculated the median (IQR) time of each interval. RESULTS: We analyzed 896 episodes of hypoglycemia in 426 patients: 698 events had only 1 hypoglycemic measurement; 165 had 2 sequential hypoglycemic measurements; and 33 had 3 sequential hypoglycemic measurements. Median (IQR) times between measurements ranged from 18 (15-23) minutes to 28 (21-38) minutes. For patients with 1 hypoglycemic measurement, less than 50% of follow-up measurements were compliant. Similarly, for those with 2 sequential hypoglycemic values, less than 50% of measurements were compliant; for those with 3 sequential hypoglycemic values, less than 58%. CONCLUSION: Many instances of hypoglycemia had intervals between sequential glucose measurements that were longer than required by policy. These longer-than-expected intervals could place patients at undue risk for a prolonged hypoglycemic event. A better understanding of barriers to post-hypoglycemic event management in inpatients is required. Inpatient nurses, who are at the forefront of assessing and treating patients with hypoglycemia, should be key partners in assessing the algorithms for hypoglycemia care.