'Didn't See the Need': Misperceptions about glucagon from the perspectives of people with diabetes and their caregivers.

AIMS: Severe hypoglycaemia among people with diabetes who use insulin can be a life-threatening complication if left untreated. Although glucagon has been approved for treatment of hypoglycaemia since the 1960s, it has been underutilized. We aimed to understand the perceptions of people with diabetes and their caregivers about glucagon. METHODS: We conducted in-depth, one-on-one telephone interviews with people with diabetes and their caregivers in the United States. The interviews included questions around general awareness of glucagon, reasons for owning or not owning glucagon, and suggestions for improving understanding of glucagon as treatment for severe hypoglycaemia. Initial synopsis and inductive codebook schema were used to analyse the responses by two independent researchers. Themes were developed from the codes, and codes were re-mapped back to the themes. RESULTS: There were 60 dyads of people with diabetes and their caregivers (N = 120). Four themes developed from the interviews: (1) for most participants, the stated reasons for not owning or renewing a prescription for glucagon included unawareness of the medication, its advantages and its value; (2) misperceptions about glucagon occurred frequently; (3) caregivers often lacked confidence in administering reconstituted injectable glucagon; and (4) education and training from healthcare providers about glucagon would be welcomed. CONCLUSIONS: This study emphasizes the need for healthcare providers to discuss hypoglycaemia prevention and events at each clinical visit, including the use of glucagon in the case of severe hypoglycaemia. Healthcare providers are encouraged to assess the knowledge of people with diabetes and their caregivers regarding treatment and prevention of hypoglycaemia.

The experience of a severe hypoglycaemic event from the perspective of people with diabetes and their caregivers: "What am I going to do?"

AIMS: Among people with diabetes using insulin, severe hypoglycaemia (SH) can be a life-threatening complication, if untreated. The personal experiences during an SH event from the perspectives of people with diabetes and their caregivers are not well-characterized. This study assessed the perceptions of the event and the decision making processes of people with diabetes (T1D n = 36; T2D n = 24) and their caregivers during SH events. METHODS: In-depth one-on-one telephone interviews were conducted with dyads of people with diabetes and caregivers in the United States (n = 120). An initial synopsis and inductive codebook schema were used to analyse the data with two independent coders (kappa = 0.87-0.89). Themes were developed from the codes, and codes were re-mapped to the themes. RESULTS: Four themes were formed: (1) Caregivers scramble to do the right thing and support people with diabetes in treating SH; (2) Decision making capacity is impaired during an SH event, often a panicked time; (3) People learn to manage SH events through their own experiences and frequently make lifestyle changes to prevent and treat future events; and (4) Discussion with healthcare providers about SH, and particularly SH treatment, is limited. CONCLUSIONS: SH events are stressful and often evoke emotional reactions that can impair decision making. Thus, advance treatment planning of SH events needs to occur. Much of the knowledge about SH treatment derives from prior experience rather than healthcare provider guidance, suggesting a need for healthcare providers to initiate proactive discussions about SH treatment.

Conversations and Reactions Around Severe Hypoglycemia (CRASH) Study: Results From People With Diabetes and Caregivers in the United States.

A survey was conducted in eight countries to examine conversations around, and experiences and treatments during, severe hypoglycemia among people with diabetes and caregivers of people with diabetes. This article reports a subgroup analysis from the United States involving 219 people with diabetes and 210 caregivers. Most respondents (79.7%) did not use professional health care services during their most recent severe hypoglycemic event, and 40.3% did not report the event to their health care providers at a subsequent follow-up visit. Hypoglycemic events left respondents feeling scared (70.9%), unprepared (42.7%), and helpless (46.9%). These clinically important psychosocial impacts on people with diabetes and caregivers underscore the need for conversations about hypoglycemia prevention and management.

Treatment and prevention of severe hypoglycaemia in people with diabetes: Current and new formulations of glucagon.

Some therapies for diabetes increase the risk of hypoglycaemia, in particular all insulins and insulin secretagogues, including the glinides and sulfonylureas. Hypoglycaemia remains a major limiting factor to successful glycaemic management, despite the availability of prevention options such as insulin analogues, continuous glucose monitoring, insulin pumps, and dogs that have been trained to detect hypoglycaemia. Non-severe (self-treated) and severe (requiring assistance for recovery) hypoglycaemia rates are higher in people with type 1 diabetes, but those with insulin-treated type 2 diabetes are also at risk. Education and regular review are essential between people with diabetes and their caregivers and healthcare professionals about symptoms, prevention and treatment. Awareness of the potential dangers of hypoglycaemia is fundamental to the optimal management of diabetes. When therapy is intensified to achieve glycaemic targets, it is important that people at risk of severe hypoglycaemia, and particularly their caregivers, have ready access to effective treatment for hypoglycaemia emergencies. The current and potential formulations of glucagon available for treatment of severe hypoglycaemia are reviewed.

Hypoglycemia Emergencies: Factors Associated with Prehospital Care, Transportation Status, Emergency Department Disposition, and Cost.

Objectives: The objectives of this study were to evaluate demographic/clinical characteristics and treatment/transportation decisions by emergency medical services (EMS) for patients with hypoglycemia and link EMS activations to patient disposition, outcomes, and costs to the emergency medical system. This evaluation was to identify potential areas where improvements in prehospital healthcare could be made. Methods: This was a retrospective analysis of the National Emergency Medical Services Information System (NEMSIS) registry and three national surveys: Nationwide Emergency Department Sample (NEDS), National Hospital Ambulatory Medical Care Survey (NHAMCS), and Medical Expenditure Panel Survey (MEPS) from 2013, to examine care of hypoglycemia from the prehospital and the emergency department (ED) perspectives. Results: The study estimated 270,945 hypoglycemia EMS incidents from the NEMSIS registry. Treatments were consistent with national guidelines (i.e., oral glucose, intravenous [IV] dextrose, or glucagon), and patients were more likely to be transported to the ED if the incident was in a rural setting or they had other chief concerns related to the pulmonary or cardiovascular system. Use of IV dextrose decreased the likelihood of transportation. Approximately 43% of patients were not transported from the scene. Data from the NEDS survey estimated 258,831 ED admissions for hypoglycemia, and 41% arrived by ambulance. The median ambulance expenditure was $664 ± 98. From the ED, 74% were released. The average ED charge that did not lead to hospital admission was $3106 ± 86. Increased odds of overnight admission included infection and acute renal failure. Conclusions: EMS activations for hypoglycemia are sizeable and yet a considerable proportion of patients are not transported to or are discharged from the ED. Seemingly, these events resolved and were not medically complex. It is possible that implementation and appropriate use of EMS treat-and-release protocols along with utilizing programs to educate patients on hypoglycemia risk factors and emergency preparedness could partially reduce the burden of hypoglycemia to the healthcare system.

GLUCAGON PRESCRIPTIONS FOR DIABETES PATIENTS AFTER EMERGENCY DEPARTMENT VISITS FOR HYPOGLYCEMIA.

OBJECTIVE: To determine the proportion of prescription fills for glucagon within 90 days of an emergency department (ED) visit for hypoglycemia. METHODS: This was a retrospective research study of glucagon prescriptions filled after an ED visit for hypoglycemia (from January 2011 to June 2014) by people with type 1 diabetes (T1D) or type 2 diabetes (T2D) taking insulin who did not already have an unexpired glucagon prescription within the Truven Health MarketScan® Research Database. RESULTS: Less than 10% (T1D: 10.9%; T2D: 3.5%) filled a glucagon prescription after the ED visit. CONCLUSION: A substantial opportunity exists to improve care for at-risk patients with diabetes through a more consistent provision of glucagon, perhaps through the implementation of a quality metric. ABBREVIATIONS: DM = diabetes mellitus; ED = emergency department; IQR = interquartile range; T1D = type 1 diabetes; T2D = type 2 diabetes.

GLUCAGON PRESCRIPTION PATTERNS IN PATIENTS WITH EITHER TYPE 1 OR 2 DIABETES WITH NEWLY PRESCRIBED INSULIN.

OBJECTIVE: To describe glucagon prescription patterns in patients with type 1 (T1DM) or type 2 diabetes (T2DM) who received an initial insulin prescription. METHODS: Retrospective analyses were conducted with data from Truven Health MarketScan databases to assess time to glucagon prescriptions: filled within 1.5 months after index date (early) or after 1.5 months postindex (nonearly). The index date was the date of first insulin prescription between January 1, 2009 and December 31, 2011; for T2DM, without an insulin prescription in the previous 6 months; for T1DM, diabetes diagnosis preindex or within 3 months postindex. RESULTS: Analysis included 8,814 patients with T1DM and 47,051 with T2DM (49.3% and 2.4%, respectively) who had glucagon prescriptions filled. The median times to first glucagon prescription were 196 days (T1DM) and 288 days (T2DM). The rates of filling glucagon were highest in the first 1.5 months. The times to first hypoglycemia-related emergency room (ER) visit for T1DM and T2DM cohorts were initially similar for those with early glucagon versus nonearly glucagon prescriptions. After 10.8 and 2.5 months postindex, respectively, the percentage of hypoglycemia-related ER visits was lower for those with early glucagon prescriptions. CONCLUSION: Glucagon prescriptions filled for patients with diabetes who are initiating insulin are low. Patients with T1DM who were younger and healthier filled glucagon prescriptions more often; patients with T2DM who were younger and sicker and had a higher percentage of hypoglycemia-related ER visit history filled glucagon prescriptions more often. Glucagon filled early was associated with a lower incidence of hypoglycemia-related ER visits.

Antihyperglycaemic treatment patterns, observed glycaemic control and determinants of treatment change among patients with type 2 diabetes in the United Kingdom primary care: a retrospective cohort study.

BACKGROUND: The initial treatment strategy for patients with type 2 diabetes includes lifestyle change recommendations. When patients are not successful in controlling their blood glucose levels through healthier lifestyle pharmaceutical agents are recommended. The objective of this study is to identify determinants of initial treatment change following initiation of non-insulin antihyperglycaemic treatment (OAD) for UK patients with type 2 diabetes. METHODS: A retrospective cohort study using primary care data from the Clinical Practice Research Datalink between January 2006 and February 2011. Each patient had an OAD prescription. The main treatment pattern outcomes were discontinuation, switching, augmentation and initiation of insulin. Glycaemic control was assessed using HbA1c. RESULTS: 63,060 patients initiated OAD therapy 2006-2010 and 3.4% were prescribed insulin during follow-up. 26% with at least four years of follow-up remained on the initial treatment. Metformin dominated (90%) in UK primary care. Around 75% had a record of HbA1c testing prior to initiating therapy. On initiating OAD, half the patients had HbA1c values >65 mmol/mol and one quarter >80 mmol/mol. The initial values of HbA1c were reduced after 12 months and remained stable. There were 15%-18% of patients whose values increased since initiating OAD. Increased baseline HbA1c is associated with increased chance of augmentation and decreased chance of discontinuation. HbA1c values at 1 year were associated with a three-fold increase in the chance of augmentation, 130% increase in the chance of switching and 14% increase in the chance of discontinuation with each 10 mmol/mol increase. Following initiation of OAD, HbA1c was reduced by an average of 16 mmol/mol during the first year. CONCLUSION: There are patients for whom glycaemic control worsens and a majority remained above the recommended level, suggesting an unmet need despite the availability of many OAD.

21 Gy single fraction prostate HDR brachytherapy: 5-year results of a single institution prospective pilot study.

PURPOSE: To present the outcome and toxicity results of a prospective trial of 21 Gy single fraction high-dose-rate (HDR) brachytherapy for men with low- or intermediate-risk prostate cancer. METHODS AND MATERIALS: Patients were treated according to an IRB-approved prospective study of single fraction HDR brachytherapy. Eligible patients had low- or intermediate-risk prostate cancer with tumor stage ≤ T2b, PSA ≤ 15, and Gleason score ≤ 7. Patients underwent trans-rectal ultrasound-guided trans-perineal implant of the prostate followed by single fraction HDR brachytherapy to a dose of 21 Gy. The primary endpoint was grade ≥ 2 urinary/GI toxicity rates. RESULTS: Twenty-six patients were enrolled with a median follow up of 5.1 years and median age of 64 years. 88.5% of patients had T1 disease, 15.4% had Gleason score 6 (84.6% Gleason 7), and median pre-treatment PSA was 5.0 ng/mL. Acute and chronic grade ≥ 2 urinary toxicity rates were 38.5% and 38.5%, respectively. There were no grade ≥ 2 acute or chronic GI toxicities. Six (23.1%) patients experienced biochemical failure, six (23.1%) patients experienced radiographic local failure, and five (19.2%) patients had biopsy-proven local failure. No patients developed regional lymph node recurrence or distant metastasis. 5-year overall survival and cause-specific survival were 96.2% and 100%, respectively. CONCLUSIONS: 21 Gy single fraction HDR brachytherapy was associated with modestly higher-than-anticipated chronic urinary toxicity, as well as high biochemical and local failure rates. The results from this prospective pilot study do not support the use of this regimen in standard clinical practice.

Hypoglycaemic events in patients with type 2 diabetes in the United Kingdom: associations with patient-reported outcomes and self-reported HbA1c.

BACKGROUND: One possible barrier to effective diabetes self-management is hypoglycaemia associated with diabetes medication. The current study was conducted to characterize hypoglycaemic events among UK patients with type 2 diabetes (T2D) treated with antihyperglycaemic medications, and assess the relationship between experience of hypoglycaemic events and health outcomes, including glycaemic control, health-related quality of life, impairment to work and non-work activities, treatment satisfaction, adherence to treatment, fear of hypoglycaemia, and healthcare resource use. METHODS: An online survey of 1,329 T2D patients in UK drawn from an opt-in survey panel was conducted in February of 2012 with monthly follow-up questionnaires for five months. Measures included self-reported HbA1c, EQ-5D, Work Productivity and Activity Impairment questionnaire, Diabetes Medication Satisfaction Tool, Morisky medication adherence scale, the Hypoglycaemia Fear Survey (revised), and self-reported healthcare resource use. Comparisons were conducted using t-tests and chi-square tests for continuous and categorical variables, respectively. RESULTS: Baseline comparisons showed that worse HbA1c, greater diabetes-related healthcare resource use, greater fear of hypoglycaemia, and impaired health outcomes were associated with experience of hypoglycaemia in the four weeks prior to baseline. Longitudinal results were similar in direction but differences on few measures were significant. CONCLUSIONS: In real-world UK T2D patients, hypoglycaemia is associated with worse self-reported glycaemic control, behaviours that contribute to worse glycaemic control, and impairment in patient-reported outcomes.

People With Diabetes and Caregivers Prefer Rescue Glucagon Treatment With a Wider Storage Temperature Range and a Nasal Administration, When Efficacy is Similar: A Discrete Choice Experiment in Spain.

BACKGROUND: Conventional injectable glucagon (IG) and nasal glucagon (NG), both having similar efficacy, are two options for the emergency treatment of severe hypoglycemia in Spain. This study elicited the effect of changes in key attributes on preferences for NG and IG medication profiles of people with diabetes and caregivers in Spain. METHODS: The relative attribute importance (RAI) that participants placed on glucagon preparation, preparation and administration time, delivery method, recovery time, device size, storage temperature, and headache risk was estimated from an online discrete choice experiment. In addition, patients and caregivers were presented with NG and IG profiles that included rates of successful administration; the proportion of participants choosing each profile was summarized. RESULTS: The analysis included 276 adults with diabetes (65% type 1) and 270 caregivers (49% type 1). Overall mean age was 40 years; 51% were female. The most important attributes were storage temperature (RAI [95% confidence interval] = 27.3% [22.9-32.2]) and delivery method (17.4% [13.1-21.9]). Headache risk (16.2% [11.8-20.7]), time to prepare and administer (14.5% [10.1-18.8]), glucagon preparation (11.4% [6.8-15.8]), recovery time (8.9% [4.3-13.3]), and device size (4.3% [0.3-8.8]) were also relevant. When comparing medication profiles, significantly more participants (78%) preferred NG over IG profiles (P < .001). CONCLUSION: Adults with diabetes and caregivers prefer a glucagon treatment with a higher rate of successful administration, wider storage temperature, and nasal delivery method, when efficacy is similar. Participants favored NG over conventional IG as a rescue medication for severe hypoglycemia. This information may help decision-making by payers and treatment discussions between health care professionals and patients.

Emerging Adult and Caregiver Psychosocial Experiences with Severe Hypoglycemic Events and the Perceived Impact of Nasal Glucagon: A Cross-Sectional Study.

INTRODUCTION: Severe hypoglycemic events are distressing. Although past studies have shown that young adulthood is a potentially distressing time, few studies have explored distress about severe hypoglycemia in this age group. The real-world psychosocial experiences of potential severe hypoglycemic events and the perceived impact of glucagon treatments like nasal glucagon are currently unknown. We explored perceptions of severe hypoglycemic events and impact of nasal glucagon on psychosocial experiences with these events in emerging adults with type 1 diabetes and caregivers of emerging adults and children/teens. Further, we compared perceptions of preparedness and protection in handling severe hypoglycemic events with nasal glucagon versus the emergency glucagon kit that requires reconstitution (e-kit). METHODS: This observational, cross-sectional study enrolled emerging adults (aged 18-26; N = 364) with type 1 diabetes, caregivers of emerging adults (aged 18-26; N = 138) with type 1 diabetes, and caregivers of children/teens (aged 4-17; N = 315) with type 1 diabetes. Participants completed an online survey about their experiences with severe hypoglycemia, perceptions of nasal glucagon impact on psychosocial experiences, and perceptions of feeling prepared and protected with nasal glucagon and the e-kit. RESULTS: Many emerging adults (63.7%) agreed that the experience of severe hypoglycemic events was distressing; 33.3% and 46.7% of caregivers of emerging adults and children/teens, respectively, reported distress. Participants reported positive perceptions of nasal glucagon impact, particularly improved confidence in other people's ability to help during severe hypoglycemic events: emerging adults, 81.4%; caregivers of emerging adults, 77.6%; caregivers of children/teens, 75.5%. Participants demonstrated higher perceptions of preparedness and protection for nasal glucagon than for the e-kit (p < 0.001). CONCLUSIONS: Participants reported improved confidence in other people's ability to help during severe hypoglycemic events since having nasal glucagon available. This suggests that nasal glucagon may help broaden the support network for young people with type 1 diabetes and their caregivers.

Development and validation of fear of hypoglycemia screener: results from the T1D exchange registry.

BACKGROUND: Fear of Hypoglycemia (FoH) in people with diabetes has a significant impact on their quality of life, psychological well-being, and self-management of disease. There are a few questionnaires assessing FoH in people living with diabetes, but they are more often used in research than clinical practice. This study aimed to develop and validate a short and actionable FoH screener for adults living with type 1 diabetes (T1D) for use in routine clinical practice. METHODS: We developed an initial screener based on literature review and, interviews with healthcare providers (HCPs) and people with T1D. We developed a cross-sectional web-based survey, which was then conducted to examine the reliability and validity of the screener. Adults (aged ≥ 18 years) with diagnosis of T1D for ≥ 1 year were recruited from the T1D Exchange Registry (August-September 2020). The validation analyses were conducted using exploratory factor analyses, correlation, and multivariable regression models for predicting cut-off scores for the final screener. RESULTS: The final FoH screener comprised nine items assessing two domains, "worry" (6-items) and "avoidance behavior" (three items), in 592 participants. The FoH screener showed good internal consistency (Cronbach's α = 0.88). The screener also demonstrated high correlations (r = 0.71-0.75) with the Hypoglycemia Fear Survey and moderate correlations with depression, anxiety, and diabetes distress scales (r = 0.44-0.66). Multivariable regression analysis showed that higher FoH screener scores were significantly associated with higher glycated hemoglobin (HbA1c) (b = 0.04) and number of comorbidities (b = 0.03). CONCLUSIONS: This short FoH screener demonstrated good reliability and validity. Further research is planned to assess clinical usability to identify patients with FoH and assist effective HCP-patient conversations.

Prevalence of fear of hypoglycemia in adults with type 1 diabetes using a newly developed screener and clinician's perspective on its implementation.

INTRODUCTION: Fear of hypoglycemia (FoH) affects quality of life, emotional well-being, and diabetes management among people with type 1 diabetes (PwT1D). American Diabetes Association's (ADA) guidelines recommend assessing FoH in clinical practice. However, existing FoH measures are commonly used in research and not in clinical practice. In this study, prevalence of FoH was assessed in PwT1D using a newly developed FoH screener for clinical practice; its association with established measures and outcomes was also determined. In addition, healthcare providers' (HCPs) perspectives on implementing FoH screener into real-world practice were explored. RESEARCH DESIGN AND METHODS: This multiphase observational study used mixed methods in two phases. First, we collected a cross-sectional survey (including the screener) from PwT1D (≥18 years) from T1D Exchange Quality Improvement Collaborative adult clinics. Pearson correlations and regression analyses were performed on diabetes outcome measures using screener scores. Second, we conducted focus groups among HCPs who treat PwT1D and descriptive analysis to summarize results. RESULTS: We included 553 PwT1D. Participants had a mean±SD age of 38.9±14.2 years and 30% reported a high FoH total score. Regression analyses showed that higher A1c and higher number of comorbidities were significantly associated with high FoH (p<0.001). High FoH worry and behavior scores were significantly associated with 8-Item Patient Health Questionnaire and 7-Item Generalized Anxiety Disorder Scale scores. Participants with ≥1 severe hypoglycemia event(s) and impaired awareness of hypoglycemia had higher odds of high FoH. Eleven HCPs participated in focus group interviews; they expressed that the FoH screener is clinically necessary and relevant but poses implementation challenges that must be addressed. CONCLUSIONS: Our results demonstrate FoH is common in PwT1D and affects their psychosocial well-being and diabetes management. In alignment with ADA position statement, HCP focus group results emphasize importance of screening for FoH. Implementing this newly developed FoH screener may help HCPs identify FoH in PwT1D.

Factors associated with treatment of women with osteoporosis or osteopenia from a national survey.

BACKGROUND: Health outcomes could be improved if women at high risk for osteoporotic fracture were matched to effective treatment. This study determined the extent to which treatment for osteoporosis/osteopenia corresponded to the presence of specific risk factors for osteoporotic fracture. METHODS: This retrospective analysis of the United States 2007 National Health and Wellness Survey included women age ≥ 40 years who reported having a diagnosis of osteoporosis (69% of 3276) or osteopenia (31% of 3276). Patients were stratified by whether they were or were not taking prescription treatment for osteoporosis/osteopenia. Using 34 patient characteristics as covariates, logistic regression was used to determine factors associated with treatment. RESULTS: Current prescription treatment was reported by 1800 of 3276 (54.9%) women with osteoporosis/osteopenia. The following factors were associated with receiving prescription treatment: patient-reported diagnosis of osteoporosis (versus osteopenia); previous bone mineral density test; ≥ 2 fractures since age 50; older age; lower body mass index; better physical functioning; postmenopausal status; family history of osteoporosis; fewer comorbidities; prescription insurance coverage; higher total prescription count; higher ratio of prescription costs to monthly income; higher income; single status; previous visit to a rheumatologist or gynecologist; and 1 or 2 outpatient visits to healthcare provider (vs. none) in the prior 6 months. Glucocorticoid, tobacco, and daily alcohol use were risk factors for fracture that were not associated with treatment. CONCLUSIONS: There is a mismatch between those women who could benefit from treatment for osteoporosis and those who are actually treated. For example, self-reported use of glucocorticoids, tobacco, and alcohol were not associated with prescription treatment of osteoporosis. Other clinical and socioeconomic factors were associated with treatment (e.g. prescription drug coverage and higher income) or not (e.g. comorbid osteoarthritis and anxiety) and could be opportunities to improve care.

Conversations and Reactions Around Severe Hypoglycemia (CRASH): Japan Results From a Global Survey of People with T1DM or Insulin-Treated T2DM and Caregivers.

AIMS: The CRASH study examined severe hypoglycemia (SH) experiences among people with diabetes (PWD) and caregivers across eight countries. Here we report findings from the Japan cohort, with references to data from the United Kingdom (UK) cohort. MATERIALS AND METHODS: Adults with type 1 (T1DM) or insulin-treated type 2 diabetes mellitus (T2DM) and caregivers (not necessarily related) were recruited from online patient panels. Participants who had experienced at least one SH event in the past 3 years were eligible for study inclusion. Participants completed an online survey regarding their experience with SH, its treatment, and actions during and after an event. RESULTS: Of the 9367 PWD and caregivers from the online patient panels, 8475 participants were ineligible and a total of 53 Japanese participants (35 T1DM, 9 T2DM, 9 caregivers) completed the survey. Most SH incidents occurred at home and were unattended by a healthcare provider. For T1DM, 29% of Japan PWD and 13% of the UK PWD called an ambulance during an SH event; of these, 90% (Japan) and 50% (UK) were transported to hospital. Glucagon use was low (3% Japan and 10% UK for T1DM). Japanese respondents reported emotional impacts of SH, including feeling scared (86% T1DM, 56% T2DM), unprepared (63% T1DM, 78% T2DM), and helpless (60% T1DM, 33% T2DM). Despite the emotional burden, most PWD did not immediately discuss their SH event with a healthcare provider, with the majority (75% T1DM, 71% T2DM) waiting until their next doctor's appointment. CONCLUSION: Conversations around SH between healthcare providers and PWD appear to be insufficient in Japan. An emotional burden of SH was reported by PWD and caregivers. Education regarding the prevention of SH and available treatment options may reduce SH events and improve treatment preparation, while alleviating PWD concerns.

The multinational Conversations and Reactions Around Severe Hypoglycemia (CRASH) study: Impact of health care provider communications and recommendations on people with diabetes.

The multinational CRASH study found that substantive recommendations from health care providers were predictive of actions taken by people with diabetes during and after a severe hypoglycemic event, which highlights the importance of equipping people with actionable strategies to prevent and treat severe hypoglycemia should a severe hypoglycemic event arise.

Evaluation of the cost and medical resource use outcomes associated with nasal glucagon versus injectable glucagon for treatment of severe hypoglycemia in people with diabetes in Canada: a modeling analysis.

OBJECTIVES: Treatments for severe hypoglycemia aim to restore blood glucose through successful administration of rescue therapy, and choosing the most effective and cost-effective option will improve outcomes for patients and may reduce costs for healthcare payers. The present analysis aimed to compare costs and use of medical services with nasal glucagon and injectable glucagon in people with type 1 and 2 diabetes in Canada when used to treat severe hypoglycemic events when impaired consciousness precludes treatment with oral carbohydrates using an economic model, based on differences in the frequency of successful administration of the two interventions. METHODS: A decision tree model was prepared in Microsoft Excel to project outcomes with nasal glucagon and injectable glucagon. The model structure reflected real-world decision-making and treatment outcomes, based on Canada-specific sources. The model captured the use of glucagon, emergency medical services (EMS), emergency room, inpatient stay, and follow-up care. Costs were accounted for in 2019 Canadian dollars (CAD). RESULTS: Nasal glucagon was associated with reduced use of all medical services compared with injectable glucagon. EMS call outs were projected to be reduced by 45%, emergency room treatments by 52%, and inpatient stays by 13%. Use of nasal glucagon was associated with reduced direct, indirect, and combined costs of CAD 1,249, CAD 460, and CAD 1,709 per severe hypoglycemic event, respectively, due to avoided EMS call outs and hospital costs, resulting from a higher proportion of successful administrations. CONCLUSIONS: When a patient with type 1 or type 2 diabetes is being treated for a severe hypoglycemic event when impaired consciousness precludes treatment with oral carbohydrate, use of nasal glucagon was projected to be dominant versus injectable glucagon in Canada reducing costs and use of medical services.

Cost of Severe Hypoglycemia and Budget Impact with Nasal Glucagon in Patients with Diabetes in Spain.

INTRODUCTION: Severe hypoglycemic events (SHE) represent a clinical and economic burden in patients with diabetes. Nasal glucagon (NG) is a novel treatment for SHEs with similar efficacy, but with a usability advantage over injectable glucagon (IG) that may translate to improved economic outcomes. The economic implications of this usability advantage on SHE-related spending in Spain were explored in this analysis. METHODS: A cost-offset and budget impact analysis (BIA) was conducted using a decision tree model, adapted for the Spanish setting. The model calculated average costs per SHE over the SHE treatment pathway following a treatment attempt with IG or NG. Analyses were performed separately in three populations with insulin-treated diabetes: children and adolescents (4-17 years) with type 1 diabetes (T1D), adults with T1D and adults with type 2 diabetes (T2D), with respective population estimates applied in BIA. Treatment probabilities were assumed to be equal for IG and NG, except for treatment success following glucagon administration. Epidemiologic and cost data were obtained from Spanish-specific sources. BIA results were presented at a 3-year time horizon. RESULTS: On a per SHE level, NG was associated with lower costs compared to IG (children and adolescents with T1D, EUR 820; adults with T1D, EUR 804; adults with T2D, EUR 725). Lower costs were attributed to reduced costs of professional medical assistance in patients treated with NG. After 3 years, BIA showed that relative to IG, the introduction of NG was projected to reduce SHE-related spending by EUR 1,158,969, EUR 142,162,371, and EUR 6,542,585 in children and adolescents with T1D, adults with T1D, and adults with insulin-treated T2D, respectively. CONCLUSIONS: In Spain, the usability advantage of NG over IG translates to potential cost savings per SHE in three populations with insulin-treated diabetes, and the introduction of NG was associated with a lower budget impact versus IG in each group.

Conversations and reactions around severe hypoglycemia (CRASH) global survey of people with type 1 diabetes or insulin-treated type 2 diabetes and caregivers: Findings from the French cohort.

AIM: The objective of the CRASH (Conversations and Reactions Around Severe Hypoglycemia) survey was to further our understanding of the characteristics, experience, behavior and conversations with healthcare professionals (HCPs) of people with diabetes (PWD) receiving insulin, and of caregivers (CGs) caring for such people, concerning hypoglycemia requiring external assistance (severe hypoglycemic events [SHEs]). METHODS: CRASH was an online cross-sectional survey conducted across eight countries. PWD with self-reported type 1 (T1D) or insulin-treated type 2 (T2D) diabetes were aged≥18 years and had experienced one or more SHEs in the past 3 years; CGs were non-medical professionals aged ≥18 years, caring for PWD meeting all the above criteria except for PWD age (≥4 rather than ≥18 years). The present report is a descriptive analysis of data from France. RESULTS: Among PWD who had ever discussed SHEs with an HCP, 38.9% of T1D PWD and 50.0% of T2D PWD reported that SHEs were discussed at every consultation; 26.3% and 8.8%, respectively, had not discussed the most recent SHE with an HCP. In total, 35.7% of T1D PWD and 53.8% of T2D PWD reported that glucagon was not available to them at the time of their most recent SHE. Only 16.9% of T1D PWD and 6.5% of T2D PWD who had discussed their most recent SHE with an HCP reported that the HCP recommended obtaining a glucagon kit or asked them to confirm that they already had one. High proportions of PWD and CGs reported that the most recent SHE had made them feel unprepared, scared and helpless and had affected mood, emotional state and activities. CONCLUSION: CRASH survey data from France identify a need for greater discussion about SHEs between HCPs and PWD and the CGs of such people, and reveal gaps in the diabetes education of PWDs and CGs.