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.

Design and Testing of a Smartphone Application for Real-Time Tracking of CSII and CGM Site Rotation Compliance in Patients With Type 1 Diabetes.

INTRODUCTION: Glycemic control in patients with type 1 diabetes can be difficult to achieve. One critical aspect of insulin delivery is site rotation, which is necessary to reduce dermatologic complications of repeated insulin infusion. No current application is designed to help patients track sites and instruct on overused sites. OBJECTIVE: The objectives of this study were to (1) design a smartphone app, Insulin Site Guide, to gather real-time information on continuous subcutaneous insulin infusion (CSII) and continuous glucose monitor (CGM) site location and rotation compliance and instruct subjects on the use of an overused site; (2) conduct a usability study to measure site rotation compliance; and (3) report subject satisfaction with the app. DESIGN: The app is installed on the subject's smartphone. Subjects use the app to record CSII and CGM placement in real-time. Data are sent to the study team at the end of the study. Subjects complete a questionnaire concerning the app. RESULTS: We report site rotation compliance data for eight subjects and survey responses for 10 subjects. Initial data from eight subjects indicate a high site rotation compliance of 84% for insulin pumps. In general, the majority of users indicate high satisfaction with the app. CONCLUSIONS: Insulin Site Guide is a mobile app that uses a novel algorithm to better guide site rotation. Use of the app has the potential to improve site rotation and decrease dermatologic complications of diabetes with long-term use.

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.

How to Best Protect People With Diabetes From the Impact of SARS-CoV-2: Report of the International COVID-19 and Diabetes Summit.

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus has rapidly involved the entire world and exposed the pressing need for collaboration between public health and other stakeholders from the clinical, scientific, regulatory, pharmaceutical, and medical device and technology communities. To discuss how to best protect people with diabetes from serious outcomes from COVID-19, Diabetes Technology Society, in collaboration with Sansum Diabetes Research Institute, hosted the "International COVID-19 and Diabetes Virtual Summit" on August 26-27, 2020. This unique, unprecedented real-time conference brought together physicians, scientists, government officials, regulatory experts, industry representatives, and people with diabetes from six continents to review and analyze relationships between COVID-19 and diabetes. Over 800 attendees logged in. The summit consisted of five sessions: (I) Keynotes, (II) Preparedness, (III) Response, (IV) Recovery, and (V) Surveillance; eight parts: (A) Background, (B) Resilience, (C) Outpatient Care, (D) Inpatient Care, (E) Resources, (F) High-Risk Groups, (G) Regulation, and (H) The Future; and 24 sections: (1) Historic Pandemics and Impact on Society, (2) Pathophysiology/Risk Factors for COVID-19, (3) Social Determinants of COVID-19, (4) Preparing for the Future, (5) Medications and Vaccines, (6) Psychology of Patients and Caregivers, (7) Outpatient Treatment of Diabetes Mellitus and Non-Pharmacologic Intervention, (8) Technology and Telehealth for Diabetes Outpatients, (9) Technology for Inpatients, (10) Management of Diabetes Inpatients with COVID-19, (11) Ethics, (12) Accuracy of Diagnostic Tests, (13) Children, (14) Pregnancy, (15) Economics of Care for COVID-19, (16) Role of Industry, (17) Protection of Healthcare Workers, (18) People with Diabetes, (19) International Responses to COVID-19, (20) Government Policy, (21) Regulation of Tests and Treatments, (22) Digital Health Technology, (23) Big Data Statistics, and 24) Patient Surveillance and Privacy. The two keynote speeches were entitled (1) COVID-19 and Diabetes-Meeting the Challenge and (2) Knowledge Gaps and Research Opportunities for Diabetes and COVID-19. While there was an emphasis on diabetes and its interactions with COVID-19, the panelists also discussed the COVID-19 pandemic in general. The meeting generated many novel ideas for collaboration between experts in medicine, science, government, and industry to develop new technologies and disease treatment paradigms to fight this global pandemic.

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.

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.

Self-Management Behaviors of Patients with Type 1 Diabetes: Comparing Two Sources of Patient-Generated Data.

OBJECTIVES: This article aims to evaluate adult type 1 diabetes mellitus (T1DM) self-management behaviors (SMBs) related to exercise and alcohol on a survey versus a smartphone app to compare self-reported and self-tracked SMBs, and examine inter- and intrapatient variability. METHODS: Adults with T1DM on insulin pump therapy were surveyed about their alcohol, meal, and exercise SMBs. For 4 weeks, participants self-tracked their alcohol, meal, and exercise events, and their SMBs corresponding with these events via an investigator-developed app. Descriptive statistics and generalized linear mixed-effect models were used to analyze the data RESULTS: Thirty-five participants self-tracked over 5,000 interactions using the app. Variability in how participants perceived the effects of exercise and alcohol on their blood glucose was observed. The congruity between SMBs self-reported on the survey and those self-tracked with the app was measured as mean (SD). The lowest congruity was for alcohol and exercise with 61.9% (22.7) and 66.4% (20.2), respectively. Congruity was higher for meals with 80.9% (21.0). There was significant daily intra- and interpatient variability in SMBs related to preprandial bolusing: recommended bolus, p < 0.05; own bolus choice, p < 0.01; and recommended basal adjustment, p < 0.01. CONCLUSION: This study highlights the variability in intra- and interpatient SMBs obtained through the use of a survey and app. The outcomes of this study indicate that clinicians could use both one-time and every-day assessment tools to assess SMBs related to meals. For alcohol and exercise, further research is needed to understand the best assessment method for SMBs. Given this degree of patient variability, there is a need for an educational intervention that goes beyond the traditional "one-size-fits-all" approach of diabetes management to target individualized treatment barriers.

Data-Driven Diabetes Education Guided by a Personalized Report for Patients on Insulin Pump Therapy.

OBJECTIVE: It is difficult to assess self-management behaviors (SMBs) and incorporate them into a personalized self-care plan. We aimed to develop and apply SMB phenotyping algorithms from data collected by diabetes devices and a mobile health (mHealth) application to create patient-specific SMBs reports to guide individualized interventions. Follow-up interventions aimed to understand patient's reasoning behind discovered SMB choices. METHODS: This study deals with adults on continuous subcutaneous insulin infusion using a continuous glucose monitor (CGM) who self-tracked SMBs with an mHealth application for 1 month. Patient-generated data were quantified and an SMB report was designed and populated for each participant. A diabetes educator used the report to conduct personalized, data-driven educational interventions. Thematic analysis of the intervention was conducted. RESULTS: Twenty-two participants recorded 118 alcohol, 251 exercise, 2,661 meal events, and 1,900 photos. A patient-specific SMB report was created from this data and used to conduct the educational intervention. High variability of SMB was observed between patients. There was variability in the percentage of alcohol events accompanied by a blood glucose check, median 79% (38-100% range), and frequency of changing the bolus waveform, median 11 (7-95 range). Interventions confirmed variability of SMBs. Main emerging themes from thematic analysis were: challenges and barriers, motivators, current SMB techniques, and future plans to improve glycemic control. CONCLUSION: The ability to quantify SMBs and understand patients' rationale may help improve diabetes self-care and related outcomes. This study describes our first steps in piloting a patient-specific diabetes educational intervention, as opposed to the current "one size fits all" approach.

Patient Perception and Satisfaction With Insulin Pump System: Pilot User Experience Survey.

BACKGROUND: The goal of this study was to assess patient perspectives and satisfaction with the MiniMed 670G insulin pump. Those participants who used the pump as part of a hybrid closed loop were also asked to provide their views on the automatic feature (auto mode). METHODS: Adults with type 1 diabetes mellitus using the Medtronic™ 670G pump were asked about their experience with the device using a semi-structured survey developed by the research team. Responses were quantified to identify emergent themes. RESULTS: Seventeen participants used the pump as part of a hybrid closed loop system, while four participants used the pump in combination with a nonintegrated continuous glucose monitoring system. Overall, participants indicated a high level of satisfaction with the pump (14/21) mostly because of improvements in blood glucose (BG) control (15/21). Least liked features were physical design and structure (6/21), frequency of user input (5/21), alert frequency (4/21), and difficulty of use (3/21). Those using the hybrid closed loop were satisfied with the auto mode feature (11/17), mostly because of improvements in BG control (9/17). The least liked features of the auto mode technology were that blood glucose levels remained elevated (5/17) and the frequency of alerts (4/17). CONCLUSION: Participants indicated a high level of satisfaction with the pump and its auto mode featured mostly because of improvements in BG control. They also pointed out some key aspects of the device that are of potential clinical or commercial relevance. Additional research is needed to further evaluate users' perspectives on this new device.

Insulin Pumping Patches: Emerging Insulin Delivery Systems.

In this special section of JDST, patch-pump delivery systems ("patch pumps") are discussed. Patch pumps are novel insulin delivery systems that have emerged on the market; offering flexible insulin delivery options. These systems offer several advantages over conventional insulin pump delivery systems and are gaining popularity. Patch pumps are free of tubing, small, and lightweight. In this special section, the authors discuss both the simple and complex patch pumps currently available on the US market as well as those that are currently under development. Current technologies used to operate these pumps are discussed in detail, and potential promising technologies are presented. Available data on patient preferences, clinical trial data, and the future of patch pumps are discussed.

Withholding Perioperative Steroids in Patients Undergoing Transsphenoidal Resection for Pituitary Disease: Randomized Prospective Clinical Trial to Assess Safety.

BACKGROUND: Perioperative steroid protocols for patients undergoing transsphenoidal surgery (TSS) for pituitary pathology vary by institution. OBJECTIVE: To assess the safety of withholding glucocorticoids in patients undergoing TSS. METHODS: Patients with an intact hypothalamic-pituitary-adrenal (HPA) axis undergoing TSS for a pituitary tumor at the same academic institution between 2012 and 2015 were randomized to either receive 100 mg of intravenous hydrocortisone followed by 0.5 mg of intravenous dexamethasone every 6 h for 4 doses (STER, n = 23) or to undergo surgery without steroids (NOSTER, n = 20). Postoperative cortisol levels were then used to determine the need for glucocorticoids after surgery. Data regarding postoperative cortisol levels, hospital stay length, and complications were collected. RESULTS: Mean postoperative 8 am cortisol levels were higher in the NOSTER group compared to the STER group (745 ± 359 nmol/L and 386 ± 193 nmol/L, respectively, P = .001) and more patients were discharged on glucocorticoids in the STER group (42% vs 12%, P = .07). There was no difference in the incidence of postoperative complications, including hyperglycemia, diabetes insipidus, or permanent adrenal insufficiency. Permanent adrenal insufficiency occurred in 8% of patients. CONCLUSION: Perioperative steroids can be safely withheld in patients with an intact HPA axis undergoing TSS. Although administration of perioperative glucocorticoids does not appear to increase the risk of complications, it may interfere with assessment of the HPA axis after surgery.

Comparing Real-Time Self-Tracking and Device-Recorded Exercise Data in Subjects with Type 1 Diabetes.

BACKGROUND: Insulin therapy, medical nutrition therapy, and physical activity are required for the treatment of type 1 diabetes (T1D). There is a lack of studies in real-life environments that characterize patient-reported data from logs, activity trackers, and medical devices (e.g., glucose sensors) in the context of exercise. OBJECTIVE: The objective of this study was to compare data from continuous glucose monitor (CGM), wristband heart rate monitor (WHRM), and self-tracking with a smartphone application (app), iDECIDE, with regards to exercise behaviors and rate of change in glucose levels. METHODS: Participants with T1D on insulin pump therapy tracked exercise for 1 month with the smartphone app while WHRM and CGM recorded data in real time. Exercise behaviors tracked with the app were compared against WHRM. The rate of change in glucose levels, as recorded by CGM, resulting from exercise was compared between exercise events documented with the app and recorded by the WHRM. RESULTS: Twelve participants generated 277 exercise events. Tracking with the app aligned well with WHRM with respect to frequency, 3.0 (2.1) and 2.5 (1.8) days per week, respectively (p = 0.60). Duration had very high agreement, the mean duration from the app was 65.6 (55.2) and 64.8 (54.9) minutes from WHRM (p = 0.45). Intensity had a low concordance between the data sources (Cohen's kappa = 0.2). The mean rate of change of glucose during exercise was -0.27 mg/(dL*min) and was not significantly different between data sources or intensity (p = 0.21). CONCLUSION: We collated and analyzed data from three heterogeneous sources from free-living participants. Patients' perceived intensity of exercise can serve as a surrogate for exercise tracked by a WHRM when considering the glycemic impact of exercise on self-care regimens.

Do Smartphone Applications Hold the Secret to Reducing Hypoglycemia in Type 1 Diabetes?

In this article in JDST, Feuerstein-Simon and colleagues examine use of a smartphone app in improving hypoglycemia awareness in type 1 diabetes (T1D). They conclude that their smartphone app, HypoMap™, has the potential to increase hypoglycemia awareness and reduce time spent with hypoglycemia in a cohort of long-standing patients with type 1 diabetes. The underlying assumption is that if patients can identify the precipitating cause, they can recognize symptoms better and potentially change behavior to prevent future hypoglycemic events. Potential limitations of this intervention include technical issues, patient burden from data entry with use of an app, and concern that this type of intervention may not be sustainable over time. While results of this pilot study suggest HypoMap may be an effective intervention in preventing hypoglycemia, further studies of increased sample size are needed to confirm these findings.

An Overview of Safety Issues on Use of Insulin Pumps and Continuous Glucose Monitoring Systems in the Hospital.

PURPOSE OF REVIEW: Summarize safety issues related to patients using insulin pump therapy and continuous glucose monitoring systems (CGMS) in the outpatient setting when they are hospitalized and to review steps that can be taken to mitigate risk associated with use or discontinuation of these devices. RECENT FINDINGS: Two recent consensus conferences were held on the topics of inpatient use of insulin pumps and CGMS devices. In addition to commonly known safety issues (e.g., device malfunction, infection), cybersecurity and the vulnerability of contemporary technology to hacking have emerged. CGMS capabilities offer the promise of advancing the goal for development of glucometry (centralized monitoring of real-time glucose data). Strategies to assuring safe use of insulin pumps and CGMS in the hospital include collaboration between the patient and staff, proper patient selection, and clear policies and procedures outlining safe use. Available data indicates few adverse events associated with these devices in the hospital. Current data suggests, with proper patient selection and a clear process in place for glycemic management, that adverse events are rare, and consensus favors allowing use of the technology in the hospital. The topic of insulin pump and CGMS in the hospital would greatly benefit from more institutions reporting on their experiences and prospective clinical trials.

Design and Testing of a Smartphone Application for Real-Time Self-Tracking Diabetes Self-Management Behaviors.

BACKGROUND: Type 1 diabetes (T1D) care requires multiple daily self-management behaviors (SMBs). Preliminary studies on SMBs rely mainly on self-reported survey and interview data. There is little information on adult T1D SMBs, along with corresponding compensation techniques (CTs), gathered in real-time. OBJECTIVE: The article aims to use a patient-centered approach to design iDECIDE, a smartphone application that gathers daily diabetes SMBs and CTs related to meal and alcohol intake and exercise in real-time, and contrast patients' actual behaviors against those self-reported with the app. METHODS: Two usability studies were used to improve iDECIDE's functionality. These were followed by a 30-day pilot test of the redesigned app. A survey designed to capture diabetes SMBs and CTs was administered prior to the 30-day pilot test. Survey results were compared against iDECIDE logs. RESULTS: Usability studies revealed that participants desired advanced features for self-tracking meals and alcohol intake. Thirteen participants recorded over 1,200 CTs for carbohydrates during the 30-day study. Participants also recorded 76 alcohol and 166 exercise CTs. Comparisons of survey responses and iDECIDE logs showed mean% (standard deviation) concordance of 77% (25) for SMBs related to meals, where concordance of 100% indicates a perfect match. There was low concordance of 35% (35) and 46% (41) for alcohol and exercise events, respectively. CONCLUSION: The high variability found in SMBs and CTs highlights the need for real-time diabetes self-tracking mechanisms to better understand SMBs and CTs. Future work will use the developed app to collect SMBs and CTs and identify patient-specific diabetes adherence barriers that could be addressed with individualized education interventions.

The female athlete triad: It takes a team.

The female athlete triad is a syndrome consisting of low energy availability (ie, burning more calories than one is taking in), menstrual dysfunction, and low bone mineral density, although all 3 components need not be present. Many providers, physical therapists, and coaches are unaware of it and thus do not screen for it. Early intervention using a team approach is essential in patients with any component of the female athlete triad to prevent long-term adverse health effects.

Consensus Statement on Use of Continuous Subcutaneous Insulin Infusion Therapy in the Hospital.

In May 2017, the Diabetes Technology Society convened a panel of US experts on inpatient diabetes management to discuss the current and potential role of continuous subcutaneous insulin infusion (CSII) therapy in the hospital. The panel (1) discussed evidence for current use of CSII in the hospital, (2) recommended contraindications for use in the hospital, and (3) recommended guidelines to maximize chances for safe use of CSII in the hospital. Panel members agreed that larger, prospective, randomized studies are needed to evaluate safety and efficacy of CSII use in the hospital. As CSII technology becomes more complex and its use increases, it is imperative that institutional protocols be in place to ensure safe use of this technology and safe transitions across care areas. Providers need to be cognizant that not all patients currently using CSII as an outpatient are appropriate candidates for continued use in the hospital. This consensus statement provides guidelines for practitioners who may encounter patients using this technology in the inpatient setting.

Self-Reported Compensation Techniques for Carbohydrate, Exercise, and Alcohol Behaviors in Patients With Type 1 Diabetes on Insulin Pump Therapy.

Studies have found variability in self-care behaviors in patients with type 1 diabetes, particularly when incorporating exercise and alcohol consumption. The objective of this study was to provide results from a survey to understand (1) insulin pump behaviors, (2) reported self-management behaviors for exercise and alcohol, and (3) perceptions of the effects of exercise and alcohol on blood glucose (BG) control. Fourteen participants from an outpatient endocrinology practice were recruited and administered an electronic survey. Compensation techniques for exercise and alcohol, along with reasons for employing the techniques were identified. Also identified were factors that participants said affected BG control with regard to exercise and alcohol. These results confirm the considerable inconsistency patients have about incorporating exercise and alcohol into decisions about self-management behaviors.

How is the weather? Forecasting inpatient glycemic control.

AIM: Apply methods of damped trend analysis to forecast inpatient glycemic control. METHOD: Observed and calculated point-of-care blood glucose data trends were determined over 62 weeks. Mean absolute percent error was used to calculate differences between observed and forecasted values. Comparisons were drawn between model results and linear regression forecasting. RESULTS: The forecasted mean glucose trends observed during the first 24 and 48 weeks of projections compared favorably to the results provided by linear regression forecasting. However, in some scenarios, the damped trend method changed inferences compared with linear regression. In all scenarios, mean absolute percent error values remained below the 10% accepted by demand industries. CONCLUSION: Results indicate that forecasting methods historically applied within demand industries can project future inpatient glycemic control. Additional study is needed to determine if forecasting is useful in the analyses of other glucometric parameters and, if so, how to apply the techniques to quality improvement.