Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic.

OBJECTIVE: To explore insulin pump-associated severe adverse events (SAEs) involving intensive care unit (ICU) admissions and deaths and examine the impact of the COVID-19 pandemic on these SAEs. METHODS: Qualitative template analysis of narrative data in reported insulin pump-associated SAEs occurring between May 1, 2019, and January 31, 2021, involving MiniMed 670G, MiniMed 630G, Omnipod, Omnipod DASH, and t:slim X2 insulin pumps. RESULTS: Over the 21-month measurement period, 460 SAEs involving an ICU admission and 288 SAEs involving a death were reported to the Food and Drug Administration. Problems with the pump or pod reservoir/cartridge were among the most frequently cited potential root causes in SAEs involving ICU admissions and deaths overall. However, problems with the infusion set or site and the pump battery or power emerged in the top three potential root causes of SAEs involving an ICU admission, whereas the patient sleeping at the time of the event and the tasks of changing the pod/infusion set, including reservoir/cartridge and programming the pump emerged in the top three for SAEs involving a death. The median monthly number of reported SAEs involving ICU admissions and deaths decreased during the pandemic, but their potential root causes were unchanged. CONCLUSIONS: Although insulin pumps are generally safe, SAEs related to their components and external factors can and do occur. By learning from the potential root causes of insulin pump-associated SAEs, providers and patients can implement corrective actions to prevent future events, thereby reducing harm.

Patterns of Telemedicine Use and Glycemic Outcomes of Endocrinology Care for Patients With Type 2 Diabetes.

Importance: Telemedicine can increase access to endocrinology care for people with type 2 diabetes (T2D), but patterns of use and outcomes of telemedicine specialty care for adults with T2D beyond initial uptake in 2020 are not known. Objective: To evaluate patterns of telemedicine use and their association with glycemic control among adults with varying clinical complexity receiving endocrinology care for T2D. Design, Setting, and Participants: Retrospective cohort study in a single large integrated US health system. Participants were adults who had a telemedicine endocrinology visit for T2D from May to October 2020. Data were analyzed from June 2022 to October 2023. Exposure: Patients were followed up through May 2022 and assigned to telemedicine-only, in-person, or mixed care (both telemedicine and in-person) cohorts according to visit modality. Main Outcomes and Measures: Multivariable regression models were used to estimate hemoglobin A1c (HbA1c) change at 12 months within each cohort and the association of factors indicating clinical complexity (insulin regimen and cardiovascular and psychological comorbidities) with HbA1c change across cohorts. Subgroup analysis was performed for patients with baseline HbA1c of 8% or higher. Results: Of 11 498 potentially eligible patients, 3778 were included in the final cohort (81 Asian participants [2%], 300 Black participants [8%], and 3332 White participants [88%]); 1182 used telemedicine only (mean [SD] age 57.4 [12.9] years; 743 female participants [63%]), 1049 used in-person care (mean [SD] age 63.0 [12.2] years; 577 female participants [55%]), and 1547 used mixed care (mean [SD] age 60.7 [12.5] years; 881 female participants [57%]). Among telemedicine-only patients, there was no significant change in adjusted HbA1c at 12 months (-0.06%; 95% CI, -0.26% to 0.14%; P = .55) while in-person and mixed cohorts had improvements of 0.37% (95% CI, 0.15% to 0.59%; P < .001) and 0.22% (95% CI, 0.07% to 0.38%; P = .004), respectively. Patients with a baseline HbA1c of 8% or higher had a similar pattern of glycemic outcomes. For patients prescribed multiple daily injections vs no insulin, the 12-month estimated change in HbA1c was 0.25% higher (95% CI, 0.02% to 0.47%; P = .03) for telemedicine vs in-person care. Comorbidities were not associated with HbA1c change in any cohort. Conclusions and Relevance: In this cohort study of adults with T2D receiving endocrinology care, patients using telemedicine alone had inferior glycemic outcomes compared with patients who used in-person or mixed care. Additional strategies may be needed to support adults with T2D who rely on telemedicine alone to access endocrinology care, especially for those with complex treatment or elevated HbA1c.

Barriers and Facilitators to Uptake of Continuous Glucose Monitoring for Management of Type 2 Diabetes Mellitus in Youth.

PURPOSE: The purpose of this study was to identify factors impacting the acceptability of continuous glucose monitoring (CGM) in adolescents and young adults (AYAs) with type 2 diabetes mellitus (T2DM). METHODS: In this single-center study, semistructured interviews were conducted with AYAs with T2DM and their parents to determine attitudes about CGM, including barriers and facilitators. Interviews were audio-recorded, transcribed, and evaluated using thematic analysis. RESULTS: Twenty AYAs and 10 parents participated (n = 30 total). AYAs were mean age 16.5 years (SD 2.2, range = 13.7-20.1) and had median diabetes duration of 1.3 years. Most were female (65%) and from minoritized background (40% non-Hispanic Black, 10% Hispanic, 5% Asian). Seven (35%) used CGM. The primary facilitator elicited was convenience over glucose meter use. Important barriers included the impact of physically wearing the device and drawing unwanted attention, desire for AYA privacy, and inadequate education about the device. CONCLUSIONS: In this diverse sample of AYAs with T2DM and their parents, CGM was generally regarded as convenient, although concerns about worsening stigma and conflict with parents were prevalent. These findings can guide the development of patient-centered approaches to CGM for AYAs with T2DM, a critical step toward reducing inequities in diabetes technology uptake.

Insulin Pump Alarms During Adverse Events: A Qualitative Descriptive Study.

OBJECTIVE: Explore alarm signals cited in insulin pump-associated adverse events (AEs), describe the clinical consequences and other root cause informing remarks that cooccurred with the alarm signals, and identify opportunities for improvements to patient education, instructional materials, and alarm systems to prevent future AEs. RESEARCH DESIGN AND METHODS: We explored the type, frequency, and associated clinical consequences of alarm signals cited in a pre-coded data set of 2294 insulin pump-associated AEs involving the MiniMed 670G, MiniMed 630G, and t:slim X2. We also explored the clinical consequences and other root cause informing remarks that cooccurred with the top 10 most frequently cited alarm signals. RESULTS: Overall, 403 AEs narratives cited at least one alarm signal. Of the 40 unique alarm signals cited, 42.5% were "alarms," 25.0% were "alerts," and 32.5% were not referenced in the instructional materials packaged with the corresponding pump. The top 10 most frequently cited alarm signals included two obstruction of flow alarms, which accounted for 49.9% of all AEs citing at least one alarm, and two unreferenced alarms. The most frequent cooccurring root cause informing remark varied across the top 10 alarm signals and revealed valuable insight into why these alarms may have occurred. CONCLUSIONS: Our findings demonstrate the value of analyzing alarm signals cited in insulin pump-associated AEs and reveal multiple opportunities for providers to educate patients on how to respond to alarm signals and manage their pumps to avoid AEs, and for insulin pump manufacturers to update instructional materials and improve alarm systems to support appropriate patient response.

Variation in telehealth use for endocrine care: Patterns and predictors under the "new normal".

INTRODUCTION: Use of telehealth for outpatient endocrine care remains common since onset of the COVID-19 pandemic, though the context for its use has matured. We aimed to describe the variation in telehealth use for outpatient endocrine visits under these "new normal" conditions and examine the patient, clinician-, and organization-level factors predicting use. METHODS: Retrospective cross-sectional study using data from the U.S. Department of Veterans Affairs (VA) Corporate Data Warehouse on 167,017 endocrine visits conducted between 3/9/21 and 3/8/22. We used mixed effects logistic regression models to examine 1) use of telehealth vs. in-person care among all visits and 2) use of telephone vs. video among the subsample of telehealth visits. RESULTS: Visits were in person (58%), by telephone (29%), or by video (13%). Unique variability in telehealth use at each level of the analysis was 56% patient visit, 24% clinician, 18% facility. The strongest predictors were visit type (first vs. follow up) and clinician and facility characteristics. Among telehealth visits, unique variability in telephone (vs. video) use at each level was 44% patient visit, 24% clinician, 26% facility. The strongest predictors of telephone vs. video were visit type, patient age, and percent of the facility's population that was rural. CONCLUSIONS: We found wide variation in use of telehealth for endocrinology under the "new normal". Future research should examine clinician and facility factors driving variation, as many may be amenable to influence by clinical leaders and leveraged to enhance the availability of telehealth for all clinically appropriate patients.

Comparison of Endocrinologists' Physical Examination Documentation for In-person vs Video Telehealth Diabetes Visits.

Objective: Outpatient diabetes mellitus (DM) care over video telehealth (TH) requires modifications to how endocrinologists complete physical examinations (PEs). But there is little guidance on what PE components to include, which may incur wide variation in practice. We compared endocrinologists' documentation of DM PE components for in-person (IP) vs TH visits. Methods: Retrospective chart review of 200 notes for new patients with DM from 10 endocrinologists (10 IP and 10 TH visits each) in the Veterans Health Administration between April 1, 2020, and April 1, 2022. Notes were scored from 0 to 10 based on documentation of 10 standard PE components. We compared mean PE scores for IP vs TH across all clinicians using mixed effects models. Independent samples t-tests were used to compare both mean PE scores within clinician and mean scores for each PE component across clinicians for IP vs TH. We described virtual care-specific and foot assessment techniques. Results: The overall mean (SE) PE score was higher for IP vs TH (8.3 [0.5] vs 2.2 [0.5]; P < .001). Every endocrinologist had higher PE scores for IP vs TH. Every PE component was more commonly documented for IP vs TH. Virtual care-specific techniques and foot assessment were rare. Conclusions: Our study quantifies the degree to which Pes for TH were attenuated among a sample of endocrinologists, raising a flag that process improvements and research are needed for virtual Pes. Organizational support and training could help increase PE completion via TH. Research should examine reliability and accuracy of virtual PE, its value to clinical decision-making, and its impact on clinical outcomes.

Specialist Perspectives on Delivering High-Quality Telemedicine for Diabetes: A Mixed Methods Survey Study.

Background: Recent recommendations guiding appropriate use of telemedicine for endocrinology care have largely relied on expert opinion due to limited evidence on factors that increase quality of telemedicine care. In this study, we assessed the perspectives of front-line specialists on factors and strategies perceived to increase quality of diabetes care delivered via telemedicine after more than 2 years of widespread use. Methods: Adult diabetes specialists in 2 academic health systems who recently used video-based telemedicine to provide diabetes care were invited to participate in an online survey study between March and April 2022. Likert-style questions, followed by related open-ended questions, assessed perspectives on availability of key resources, factors affecting quality, and anticipated benefits from telemedicine for diabetes. Results: Response rate was 52% (56/111). More than half (54%) of participants reported better overall quality of diabetes care with face-to-face care vs telemedicine. Participants reported clinical data supporting high-quality care, such as home blood glucose readings and vital signs, were often not available with telemedicine. Patient factors, including comorbidities and communication barriers, reduced anticipated benefit from telemedicine, while geographic and mobility barriers increased expected benefit. Providers described multiple health care setting resources that could promote high-quality telemedicine diabetes care, including greater support for sharing patient-generated health data and coordinating multidisciplinary care. Conclusions: After 2 years of sustained use, diabetes specialists identified telemedicine as an important way to enhance access to care. However, specialists identified additional supports needed to increase appropriate use and delivery of high-quality telemedicine care for patients with complex clinical needs.

Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes.

Objective: To explore the clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Research Design and Methods: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2429) of reported AEs that occurred during the first 6 months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed™ 670G, (2) MiniMed™ 630G, (3) Omnipod®, (4) Omnipod DASH®, and (5) t:slim X2™. Results: Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose [BG] >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings. Conclusions: Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.

Diabetes Care Network: A Novel Model to Disseminate Team-Based Diabetes Specialty Care in a Rural Population.

PURPOSE: The purpose of the study was to examine the impact of a novel approach to provide diabetes specialty team care to rural patients with type 2 diabetes (T2DM) on clinical outcomes and processes of care. METHODS: Diabetes Care Network (DCN) provides Veterans with T2DM and elevated A1C an initial 6-week period of remote self-management education and support and medication management by a centrally located team of diabetes specialists. Participants are then comanaged by remote liaisons embedded in rural primary care facilities for the remainder of the 12-month intervention. In this pre-post intervention study, 87 Veterans enrolled in DCN from 2 different clinical sites had baseline and 12-month postenrollment A1C, systolic blood pressure, weight, and LDL cholesterol levels collected and compared using paired t tests. RESULTS: Participants were mostly male and White with elevated baseline A1C. Participants from both sites had significant improvement in A1C over the 12-month intervention period compared to an increase in the 12 months prior to enrollment. There were also significant improvements in LDL and systolic blood pressure at 1 site, with no significant change in weight at either site. CONCLUSIONS: DCN participants had significant improvement in A1C after not meeting similar goals previously in a robust primary care setting. A technology-enabled collaborative partnership between centrally located diabetes care teams and local liaisons is a feasible approach to enhance access to diabetes specialty care for rural populations.

Changes in Self-management During the COVID-19 Pandemic Among Adults with Type 2 Diabetes at a Federally Qualified Health Center.

The COVID-19 pandemic affected how adults with diabetes perform self-management, and impacts may be greater among vulnerable populations. We assessed the impact of the pandemic on diabetes self-management among adults with type 2 diabetes at a Federally Qualified Health Center. Participants were surveyed by phone in Spanish and English from July to October of 2020. Most respondents (74%) were Latino and preferred to speak Spanish, with mean age of 54 years and mean HbA1c of 9.2%. Fifty-three percent reported less physical activity during the pandemic. While 43% had more difficulty obtaining healthy food, 38% reported eating more healthfully. Sixty-one percent had increased difficulty accessing medical care. Many felt more socially isolated (49%) and stressed (51%). Changes in diabetes self-management were both positive and negative for majority Latino patients in this low-resource community, which may require tailored approaches to mitigate negative impacts of the pandemic on physical and mental health.

Impact of a Dyadic Intervention on Family Supporter Involvement in Helping Adults Manage Type 2 Diabetes.

BACKGROUND: Family support for adults' diabetes care is associated with improved self-management and outcomes, but healthcare providers lack structured ways to engage those supporters. OBJECTIVE: Assess the impact of a patient-supporter diabetes management intervention on supporters' engagement in patients' diabetes care, support techniques, and caregiving experience. DESIGN: Multivariate regression models examined between-group differences in support-related measures observed as part of a larger trial randomizing participants to a dyadic intervention versus usual care. PARTICIPANTS: A total of 239 adults with type 2 diabetes and either A1c >8% or systolic blood pressure >160mmHg enrolled with a family supporter. INTERVENTION: Health coaches provided training on positive support techniques and facilitated self-management information sharing and goal-setting. MAIN MEASURES: Patient and supporter reports at baseline and 12 months of supporter roles in diabetes care and caregiving experience. RESULTS: At 12 months, intervention-assigned patients had higher odds of reporting increased supporter involvement in remembering medical appointments (AOR 2.74, 95% CI 1.44, 5.21), performing home testing (AOR 2.40, 95% CI 1.29, 4.46), accessing online portals (AOR 2.34, 95% CI 1.29, 4.30), deciding when to contact healthcare providers (AOR 2.12, 95% CI 1.15, 3.91), and refilling medications (AOR 2.10, 95% CI 1.14, 3.89), but not with attending medical appointments or with healthy eating and exercise. Intervention-assigned patients reported increased supporter use of autonomy supportive communication (+0.27 points on a 7-point scale, p=0.02) and goal-setting techniques (+0.30 points on a 5-point scale, p=0.01). There were no differences at 12 months in change scores measuring supporter distress about patients' diabetes or caregiving burden. Intervention-assigned supporters had significantly larger increases in satisfaction with health system support for their role (+0.88 points on a 10-point scale, p=0.01). CONCLUSIONS: A dyadic patient-supporter intervention led to increased family supporter involvement in diabetes self-management and increased use of positive support techniques, without increasing caregiver stress.

A Risk Stratification Approach to Allocating Diabetes Education and Support Services.

The objective of this study was to describe a predictive modeling approach to risk stratify people with type 2 diabetes for diabetes self-management education and support (DSMES) services. With data from a large health system, a predictive model including age, glycated hemoglobin (HbA1c), and insulin use among other factors, was developed to assess risk of future high HbA1c. The model was retrospectively applied to a cohort of people who received DSMES over a 2-year period to assess the impact of DSMES on glycemia by risk strata. Of 6934 eligible people, 4014 (58%) were in the composite low-risk group and 2604 (38%) were in the composite high-risk group. Mean HbA1c change after DSMES was -0.38% in the low-risk group and -0.84% in the high-risk group. This analysis demonstrates the potential application of predictive modeling as one approach to target DSMES resources to people who will benefit most.

Patient and supporter factors affecting engagement with diabetes telehealth.

OBJECTIVES: To assess what patient, family supporter, and call characteristics predicted whether patients completed automated and coach-provided calls in a telehealth diabetes intervention. STUDY DESIGN: A total of 123 adults with type 2 diabetes and high glycated hemoglobin A1c (HbA1c) or blood pressure, enrolled with a family supporter, received automated interactive voice response (IVR) and coach-provided visit preparation calls over 12 months. METHODS: Data from baseline surveys and diabetes-related clinical information from patient medical records were entered into multilevel, multivariate regression models of associations between participant and call characteristics with call completion. RESULTS: A total of 76.3% of 2784 IVR calls and 75.8% of 367 visit preparation calls were completed. For IVR calls, patients with recent call-triggered provider alerts had higher odds of call completion (adjusted odds ratio [AOR], 3.5; 95% CI, 2.2-5.5); those with depressive symptoms (AOR, 0.4; 95% CI, 0.2-0.9), higher HbA1c (AOR, 0.8; 95% CI, 0.6-0.99), and more months in the study (AOR, 0.9; 95% CI, 0.87-0.94 per month) had lower odds. For visit preparation calls, higher patient activation scores predicted higher call completion (AOR, 1.4; 95% CI, 1.1-1.9); patient college education predicted less call completion (AOR, 0.3; 95% CI, 0.2-0.6). Supporter help taking medications predicted less completion of both call types. Patient age did not predict call completion. CONCLUSIONS: Patients of all ages completed telehealth calls at a high rate. Automated IVR calls were completed more often when urgent issues were identified to patients' providers, but less often if patients had high HbA1c or depression. Visit preparation call content should be tailored to patient education level. Family help with medications may identify patients needing additional support to engage with telehealth.

Cost-effectiveness of empagliflozin versus weekly semaglutide as add-on therapy for Type 2 diabetes.

Aim: Perform a cost-effectiveness analysis of addition of subcutaneous semaglutide versus empagliflozin to usual treatment for patients with Type 2 diabetes and cardiovascular disease in US setting. Materials & methods: A Markov decision model estimated the impact of each strategy using cardiovascular complication rates based on EMPA-REG and SUSTAIN-6 trials. Modeled cohorts were followed for 3 years at 1-month intervals beginning at age 66. Results: Compared with empagliflozin, semaglutide resulted in cost of US$19,964 per quality-adjusted life-year gained. In one-way sensitivity analysis, only semaglutide cost >US$36.25/day (base case US$18.04) resulted in empagliflozin being preferred at a willingness-to-pay threshold of US$50,000/quality-adjusted life-year gained. Conclusion: For patients with Type 2 diabetes and cardiovascular disease, semaglutide is likely more cost-effective than empagliflozin added to usual treatment.

A Coordinated Population Health Approach to Diabetes Education in Primary Care.

PURPOSE: The purpose of this feasibility study was to determine the effectiveness of an insurer-based diabetes educator (DE)-driven intervention that relies on systematic restructuring of primary care (PC) linking DE services through population health, practice redesign, and coordinated care for patients with diabetes mellitus (DM) identified as high risk. METHODS: Two DEs were introduced as members of PC teams and worked with practice-based care managers (PBCMs) to identify and refer DM patients considered at high risk, A1C >9%, DM-related emergency room visit or hospitalization, or reported barriers to care. Elements shown to ensure quality, including population management, diabetes self-management education and support (DSMES), and coordinated patient-centered team-based PC, were central to intervention. A1C, low-density lipoprotein (LDL), and body mass index (BMI) were collected at baseline and outcomes were followed at 3, 6, 9, and 12 months after intervention. RESULTS: For patients who received intervention, A1C decreased on average 1.2% (95% confidence interval [CI], 0.8-1.5) from 9.6% (81 mmol/mol) to 8.4% (68 mmol/mol) over 6 months and by 1.1% (95% CI, 0.7-1.5) from 9.2% (77 mmol/mol) to 8.1% (65 mmol/mol) over 12 months, indicating durable improvement in glycemic control. There was no significant change in BMI, and LDL improvement observed at 9 months was lost by 12-month follow-up. CONCLUSION: Findings support the feasibility of a DE-driven intervention for patients with DM at high risk through a coordinated PC approach that improves glycemic control. The feasibility and clinical outcome of this model warrant consideration of a fresh role for DEs in the complex environment of value-based care.

A combined therapeutic regimen of buspirone and environmental enrichment is more efficacious than either alone in enhancing spatial learning in brain-injured pediatric rats.

Buspirone, a 5-HT1A receptor agonist, and environmental enrichment (EE) enhance cognition and reduce histopathology after traumatic brain injury (TBI) in adult rats, but have not been fully evaluated after pediatric TBI, which is the leading cause of death in children. Hence, the aims of this study were to assess the efficacy of buspirone alone (Experiment 1) and in combination with EE (Experiment 2) in TBI postnatal day-17 male rats. The hypothesis was that both therapies would confer cognitive and histological benefits when provided singly, but their combination would be more efficacious. Anesthetized rats received a cortical impact or sham injury and then were randomly assigned to receive intraperitoneal injections of buspirone (0.08 mg/kg, 0.1 mg/kg, and 0.3 mg/kg) or saline vehicle (1.0 mL/kg) 24 h after surgery and once daily for 16 days (Experiment 1). Spatial learning and memory were assessed using the Morris water maze (MWM) on post-operative days 11-16, and cortical lesion volume was quantified on day 17. Sham controls for each condition were significantly better than all TBI groups. In the TBI groups, buspirone (0.1 mg/kg) enhanced MWM performance versus vehicle and buspirone (0.08 mg/kg and 0.3 mg/kg) (p<0.05) and reduced lesion volume relative to vehicle (p=0.038). In Experiment 2, buspirone (0.1 mg/kg) or vehicle was combined with EE after TBI, and the data were compared to the standard (STD)-housed groups from Experiment 1. EE lead to a significant enhancement of spatial learning and a reduction in lesion size versus STD. Moreover, the combined treatment group (buspirone+EE) performed markedly better than the buspirone+STD and vehicle+EE groups, which suggests an additive effect and supports the hypothesis. The data replicate previous studies assessing these therapies in adult rats. These novel findings may have important rehabilitation-relevant implications for clinical pediatric TBI.