BETH MITCHELL's research while affiliated with Eli Lilly and Company and other places

Publications (42)

Article
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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 st...
Article
Background: Severe hypoglycemia (SH) is feared by people with diabetes (PwD) and those who care for them due to its impact on everyday life. Studies have shown that ready-to-use nasal glucagon (NG) is preferred over reconstitutable injectable glucagon; however, real-life experiences that PwD and health care providers (HCPs) have with NG are unknown...
Article
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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 treat...
Article
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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 val...
Article
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:...
Article
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Background: For individuals managing diabetes, the administration of glucagon for severe hypoglycemia can be lifesaving, yet, until recently, there were no easy-to-use devices for these stressful emergencies. New products have emerged to meet this need, including nasal glucagon (NG) and auto-injector glucagon (AI). This study evaluated the psychom...
Article
Hypoglycemia risk and its impact on daily life is always present for people with diabetes and their caregivers (CG) . With the goal of positively impacting the lives of those who use insulin, advances in glucagon and its delivery, have made it ready-to-use, expanding the community of people who could act in an emergency. This qualitative study elic...
Article
Experiences of a severe hypoglycemic event (SHE) , although infrequent occurrences, may interfere with engaging in social activities and increase distress. Previous work in parents suggests having nasal glucagon (NG) - a ready-to-use rescue agent for SHE - alleviates some of these psychosocial concerns. To examine whether young adults also perceive...
Article
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 n...
Article
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 Th...
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IntroductionSevere 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...
Article
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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)...
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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 ev...
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Objectives Treatments for severe hypoglycemia aim to restore blood glucose through successful administration of a 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...
Article
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 persons with diabetes (PWD) receiving insulin, and of their caregivers (CGs), concerning hypoglycemia requiring extern...
Article
Full-text available
Aims Among people with diabetes using insulin, severe hypoglycemia (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...
Article
Introduction Information on experience/management of severe hypoglycaemic events (SHEs) among people with insulin-treated diabetes (PWD) and caregivers (CGs) providing care to PWD was sought. Materials and methods An online cross-sectional survey was conducted in eight countries. Inclusion criteria: PWD (aged ≥ 18 years; self-reported type 1 [T1D]...
Article
Objective: To examine reliability and validity of a newly developed fear of hypoglycemia (FoH) screener as a practical and actionable tool for in-clinic use in adults with type 1 diabetes (T1D), in accordance with ADA’s position on psychosocial care. Methods: In this validation study, adults with T1D were recruited from the T1D Exchange Registry to...
Article
BACKGROUND: Hypoglycemia is a major limiting factor in achieving glycemic control in persons with diabetes. In some instances, recovery from a severe hypoglycemia event may require health care resource utilization (HCRU), including the use of emergency medical services (EMS), visits to the emergency department (ED), and inpatient hospitalization. O...
Article
Full-text available
Introduction Information on experience/management of severe hypoglycaemic events (SHEs) among people with insulin-treated diabetes (PWD) and caregivers (CGs) providing care to PWD was sought. Materials and methods An online cross-sectional survey was conducted in eight countries. Inclusion criteria: PWD (aged ≥ 18 years; self-reported type 1 [T1D]...
Article
Background A global cross-sectional survey (CRASH) was designed to provide information about the experiences of people with diabetes (PWD) and their caregivers in relation to severe hypoglycaemic events. Methods Adults with type 1 diabetes or insulin-treated type 2 diabetes who had experienced one or more severe hypoglycaemic events within the past...
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Background Half-unit pens offer the ability to dose insulin more precisely. Information about half-unit pen use and evidence of their benefits and drawbacks is limited. This study aims to characterize people with type 1 diabetes (T1D) who have used (current/former = EVER) vs. those who have never used half-unit pens (NEVER users) and to understand...
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Objectives: Fear of hypoglycaemia (FoH) has been associated with suboptimal diabetes management and health outcomes. This study investigated factors associated with behavioural and emotional aspects of FoH among adults living with type 1 diabetes (T1D) mellitus. Design: Cross-sectional study. Setting: Online survey hosted on T1D Exchange Glu,...
Article
Full-text available
Objectives The CRASH cross-sectional study was conducted to better understand the severe hypoglycaemia experiences of persons with diabetes (PWD) and caregivers (CGs). Methods Adults with type 1 (T1D) or type 2 diabetes (T2D) and CGs were recruited in 8 countries; Canadian cohort data are reported here. Insulin-treated PWD who reported a severe hy...
Article
The CRASH online survey examined the experience and treatment of a severe hypoglycemic event (SHE) in people with T1DM or insulin-treated T2DM (PWD) or caregivers (CG). Eligible participants experienced ≥1 SHE in the last 3 years with insulin treatment at the time of event. Reported here are results from PWD aged ≥65 (T1DM 74, T2DM 104) and CG (T1D...
Article
Fear of hypoglycemia (FoH) contributes to poor behavioral and glycemic outcomes. The ADA position statement on psychosocial care for people with diabetes recommends screening for FoH, with referral if positive. A clinically useful screener for FoH does not exist, hindering further actions by clinicians to address FoH in their patients. As part of a...
Article
Objective: This study assessed preference, hesitation using, perceived ease of use, and feeling prepared and protected for nasal glucagon (NG) vs. autoinjector glucagon (AI) for rescue treatment of severe hypoglycemia (SH) among people with diabetes (PWDs), caregivers (CGs) and acquaintances (AQs). Methods: US PWDs (type 1 or 2, on insulin; n=405),...
Article
Full-text available
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, ins...
Article
Full-text available
Purpose: People with diabetes taking insulin are at risk of severe hypoglycemia, an unpredictable, life-threatening event that requires assistance from others. Outside the clinical setting, glucagon is indicated for the treatment of hypoglycemia. However, there is significant unmet medical need to improve successful administration of glucagon by c...
Article
The CRASH study examines the experience and treatment of a severe hypoglycemia event (SHE) among people with T1DM (ppl w/T1DM) or insulin-treated ppl w/T2DM and caregivers. The online survey was conducted in 8 countries. To be eligible in the global study, ppl had experienced or cared for a person who had ≥1 SHE in the last 3 years. SHE was defined...
Article
Fear of hypoglycemia (FoH) has been associated with suboptimal diabetes management and health outcomes. The American Diabetes Association recommends further mental health evaluation and treatment if a person with diabetes has a positive screen for FoH. This study investigated factors associated with behavioral and emotional aspects of FoH among adu...
Article
Background: Severe hypoglycemic events (SHEs) in patients with diabetes are associated with substantial health care costs in the United States (US). Injectable glucagon (IG) is currently available for treatment of severe hypoglycemia but is associated with frequent handling errors. Nasal glucagon (NG) is a novel, easier-to-use treatment that is mo...
Article
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 diabe...
Article
People with type 1 diabetes (PWD) that strive for lower glucose targets are in need of more precise dosing and may require smaller insulin dose adjustments. Most currently available pens deliver insulin in one unit (U) increments, and few deliver half (0.5) U. There is a need to better understand who is using half unit pens (HUP) and their potentia...
Article
Glycemic Variability (GV) and Treatment Satisfaction (TS) are not accurately reflected in HbA1c. This study explored GV measures and their effect on insulin TS, productivity and activity in a real-world population with T1D. This prospective survey was of 98 adults from the T1D Exchange online patient community. Surveys were completed and CGM data w...
Article
Background: Nasal glucagon [NG] is a compact, portable, ready-to-use nasal spray for the treatment of severe hypoglycemic events [SHE] via intranasal absorption. Current treatment with intramuscular glucagon [IMG] requires multiple steps to administer, including reconstitution, and is difficult to administer for caregivers or passersby. Due to its...
Article
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) o...

Citations

... Hypoglycemia is a known barrier to achieving glycemic control goals in people with diabetes. Fear of hypoglycemia is common in subjects with T1D and affects their psychosocial well-being and diabetes management [3]. ...
... 8 11 The new screener has demonstrated good validity and internal consistency; its two-factor structure is consistent with existing literature on FoH in PwT1D as it assesses both worry and behavioral avoidance related to hypoglycemia. 12 The current study aims to assess the prevalence of FoH using a newly developed FoH screener in a sample of PwT1D from adult clinics. We also sought to understand the association of the FoH screener with other established measures of depression and anxiety. ...
... Finally, participants completed the Prepared and Protected subscale of the Glucagon Attitudes Questionnaire [28], which asked about their perceptions of feeling prepared and protected with two glucagon devices: the e-kit and nasal glucagon (Supplementary Material). Participants rated their agreement with statements on a scale from 1 (''very unlikely'') to 7 (''very likely'') for both devices. ...
... In this study, Baqsimi demonstrated a statistically significantly lower maximum blood glucose level compared to Gvoke and Zegalogue in adults, which may have implications for the re-establishment of euglycemia INTRODUCTION Severe hypoglycemia, a low blood glucose event characterized by altered mental or physical status requiring assistance for recovery, is a barrier to glycemic control, places a substantial burden on patients and caregivers and is a barrier to management for health care professionals. Severe hypoglycemia is common in clinical practice [1][2][3] and is associated with poorer outcomes, including mortality, cardiovascular disease and cognitive dysfunction [4][5][6]. Prompt administration of rescue therapy is necessary to prevent further cognitive impairment. ...
... To our knowledge, there are no studies directly comparing the preferences of patients for these ready-to-use glucagon options. A previous discrete choice experiment study conducted in Spain compared the attributes associated with Baqsimi to those associated with IG [28]. The results indicated that patients prefer a glucagon treatment with higher success rates, wider storage temperatures and a nasal delivery method when the efficacy of both treatments is similar [28]. ...
... 71 A study from Spain reports that the usage of intranasal glucagon was associated with better compliance since no professional help was needed in comparison to injectable glucagon as well as reduced expense for the health-care system. 72 A recent systematic meta-analysis (using controlled randomized studies) compared the effectiveness of intranasal glucagon with injected intramuscular/subcutaneous glucagon for the management of hypoglycaemia in patients with T1DM. This meta-analysis indicated that in patients with T1DM intranasal as well as intramuscular/subcutaneous glucagon were equally effective in resolving hypoglycaemia. ...
... The data on SH events in the 12 months before survey completion align with recent surveys of individuals with type 1 diabetes in other countries that reported means of 1.5-4.2 SH events in the previous 12 months (39,40). Importantly, CGM users among the surveyed sample continued to experience SH events, albeit fewer than non-CGM users. ...
... Importantly, the survey highlighted the emotional burden of SH on those affected, showing a considerable proportion of participants expressing worry or concern (67.7%), fear (54.4%), panic (52.5%), embarrassment (50.6%), and shame (21.2%) in connection with SH events. These findings are reflective of the findings of other recent survey studies on the negative emotional impact of SH on individuals with type 1 diabetes (39)(40)(41)(42)(43). ...
... Importantly, the survey highlighted the emotional burden of SH on those affected, showing a considerable proportion of participants expressing worry or concern (67.7%), fear (54.4%), panic (52.5%), embarrassment (50.6%), and shame (21.2%) in connection with SH events. These findings are reflective of the findings of other recent survey studies on the negative emotional impact of SH on individuals with type 1 diabetes (39)(40)(41)(42)(43). ...
... Avoiding the hypoglycemic episodes can be achieved by training the patient's caregivers in quick decision-making, to correct the critical situations that affect the state of health. Additionally, the patient's own previous experiences can be of great help in solving the hypoglycemic occurrence [30]. (2) Diabetics with cognitive impairments, by proving difficulties in adjusting the treatment doses and the occurrence of hypoglycemia episodes, represent essential risk factors in optimizing the therapeutic scheme and keeping the condition under control [31]. ...