Tirzepatide Improved Health-Related Quality of Life Compared with Insulin Lispro in Basal Insulin-Treated Adults with Type 2 Diabetes and Inadequate Glycaemic Control: A Randomised Controlled Phase 3b Trial (SURPASS-6).

INTRODUCTION: Patients with type 2 diabetes (T2D) who require intensification of basal insulin therapy need treatment options that can improve their health-related quality of life (HRQoL) and translate into better outcomes. These analyses compared patient-reported outcomes (PROs) in patients with T2D receiving tirzepatide or insulin lispro. METHODS: The randomised, open-label, multinational, phase 3b SURPASS-6 trial (NCT04537923) was conducted at 135 medical research centres and hospitals in 15 countries and compared two recommended treatment intensification strategies in people with T2D and inadequate glycaemic control on basal insulin: addition of once-weekly tirzepatide versus addition of prandial insulin lispro. Randomisation was stratified by country, baseline glycated haemoglobin level and metformin use. PROs were measured using the Short Form-36 Health Survey version 2 (SF-36v2) acute form (secondary outcome), EQ-5D-5L, Ability to Perform Physical Activities of Daily Living (APPADL) questionnaire and Impact of Weight on Self-Perceptions (IW-SP) questionnaire (tertiary/exploratory outcomes). PROs were compared for the tirzepatide-pooled dose group (5, 10 and 15 mg) and each tirzepatide dose group versus insulin lispro at 52 weeks using the modified intention-to-treat efficacy analysis set. RESULTS: Between 19 October 2020 and 01 November 2022, 2267 people were assessed and 1428 participants with T2D were randomised. At 52 weeks, participants in the tirzepatide-pooled group had statistically significant improved scores across all SF-36v2 domains and both component summary scores compared with insulin lispro-treated participants (p < 0.05), with the largest differences observed in the general health, vitality and mental health domains. Statistically significant improved APPADL and IW-SP total scores, as well as EQ visual analogue scale and EQ-5D-5L index scores (after adjustment for baseline scores), were observed in tirzepatide-pooled participants compared with insulin lispro-treated participants. CONCLUSIONS: In adult patients with T2D and inadequate glycaemic control with basal insulin, tirzepatide treatment was associated with greater improvements in HRQoL than prandial insulin therapy in addition to clinically significant improvements in glycaemic and body weight-related parameters.

Basal insulin, which controls blood sugar at times when not eating but when the body still needs energy, may not provide sufficient glycaemic control for some people with type 2 diabetes (T2D). These people require additional therapy to improve their health-related quality of life (HRQoL) and achieve better outcomes. This phase 3 study (SURPASS-6) compared patient-reported outcomes, including HRQoL, between people with T2D on basal insulin receiving additional therapy with tirzepatide or insulin lispro (a fast-acting insulin analogue mealtime injection). Patient-reported outcomes were assessed using several validated measures ­ the Short Form-36 Health Survey version 2 (SF-36v2) acute form (a measure of HRQoL), the EQ-5D-5L (a measure of overall health status), the Ability to Perform Physical Activities of Daily Living (APPADL) questionnaire and the Impact of Weight on Self-Perceptions (IW-SP) questionnaire. The results in the two treatment groups were compared at the end of the treatment period (52 weeks). At 52 weeks, participants in the tirzepatide group had statistically significant improved scores across all HRQoL aspects measured by the SF-36v2 compared with participants in the insulin lispro group, with the largest differences observed in general health, vitality and bodily pain. Statistically significant improved EQ-5D-5L, APPADL and IW-SP scores were also observed in participants in the tirzepatide group compared with the insulin lispro group. In adults with T2D who require therapy in addition to basal insulin, tirzepatide treatment was associated with greater improvements in HRQoL than mealtime insulin therapy, as well as clinically significant improvements in blood sugar and body weight control.

Weight-reduction preferences among OBSERVE study participants with obesity or overweight: opportunities for shared decision-making.

OBJECTIVE: Limited recent evidence exists regarding weight-reduction preferences among people with obesity in the United States (US). We assessed preferred magnitudes of weight reduction among adults with obesity and how these preferences differ by participant characteristics. METHODS: OBSERVE was a cross-sectional study assessing perceptions of obesity and anti-obesity medication (AOMs) among people with obesity, healthcare providers, and employers in the US. Adults with obesity and overweight with obesity-related complications self-reported current weight and weight they associated with 5 preferences ("dream," "goal," "happy," "acceptable," and "disappointed"). Preferred percent weight reductions for each preference were calculated. Multivariable regression analyses were performed identifying associations between weight-reduction preferences and participant characteristics. RESULTS: The study included 1007 participants (women: 63.6%; White: 41.0%; Black or African American: 28.9%; Asian: 6.5%; Hispanic: 15.3%; median body mass index [BMI]: 34.2 kg/m2). Median preferred percent weight reductions were: dream=23.5%; goal=16.7%; happy=14.6%; acceptable=10.3%; disappointed=4.8%. Women reported higher preferred weight reductions than men. Preferred weight reductions among Black/African American participants were lower than White participants. Regression analyses indicated significant associations, with higher preferred magnitudes of weight reduction within females, higher weight self-stigma, and BMI class in Hispanic participants compared to White. CONCLUSION: In this large, real-world study, preferred magnitudes of weight reduction exceeded outcomes typically achieved with established nonsurgical obesity treatments but may be attained with bariatric procedures and newer and emerging AOMs. Respecting patients' preferences for treatment goals with obesity management could help support shared decision-making. Evaluating for an individual's contributors to weight preferences, such as weight self-stigma, can further benefit holistic obesity care.

Perceptions and Experiences of People with Obesity and Type 2 Diabetes Around Appetite and Eating Behaviors: A Qualitative Study.

INTRODUCTION: Chronic weight management and treatments for type 2 diabetes (T2D) involve a combination of lifestyle-based (diet, exercise) and pharmaceutical interventions. In people with obesity or T2D, understanding the impact of drivers/triggers on appetite and eating behaviors can be crucial to successful medical management. This study aimed to characterize perceptions and experiences regarding appetite and eating behaviors among people with obesity or T2D and identify drivers/triggers of food choices. METHODS: This non-interventional, cross-sectional, qualitative study utilized semi-structured concept elicitation interviews to explore the perceptions of people with obesity and/or T2D around appetite, eating behaviors and drivers/triggers of food choices. Adult US residents (≥ 18 years) with stable body weight (± 5 kg) in the 3 months preceding participation were included in the study. RESULTS: Forty-five participants (obesity: n = 15; overweight: n = 10; T2D: n = 20) were interviewed. Interviews were audio-recorded and transcribed verbatim for analysis. A subset of participants described eating behaviors on smartphone-based app tasks over 5 days. Most (> 96%) discussed the influence of hunger, cravings and satiety on food choices. Participants identified 22 drivers/triggers (including health, 95.6%; culture/heritage, 93.3%; location, 91.1%; stress, 88.8%). Participants also discussed associations between drivers/triggers and eating behavior concepts (appetite, hunger, cravings, satiety, motivation/determination). A conceptual model illustrating eating behavior concepts and related drivers/triggers was developed. The concept elicitation interviews identified a multitude of drivers and triggers and characterized the association of such drivers/triggers with seven core patient-reported concepts encompassing eating behaviors. CONCLUSION: The findings build upon existing models of factors influencing food choices. Findings confirm prior research regarding impact of drivers/triggers on food choice in people with obesity and T2D and indicate underlying disease state does not appear to influence eating behaviors in people with stable body weight.

Understanding the impact of non-alcoholic steatohepatitis with metabolic comorbidities on adults: a real-world qualitative study.

OBJECTIVE: Limited real-world evidence exists to better understand the patient experience of living with symptoms and impacts of non-alcoholic steatohepatitis (NASH). This study aimed to (1) describe patient-reported perspectives of NASH symptoms and impacts on patients' daily lives and (2) develop a patient-centered conceptual NASH model. METHODS: A cross-sectional study using semi-structured qualitative interviews was conducted among adults (≥18 years) in the United States living with NASH. Eligible participants were diagnosed with NASH, had mild to advanced fibrosis (F1-F3), and no other causes of liver disease. The interview guide was informed by a targeted literature review (TLR) to identify clinical signs, symptoms, impacts, and unmet treatment needs of NASH. Participants described their experiences and perspectives around NASH and the symptoms, symptom severity/bother, and impact of NASH on their daily activities. Interviews were audio-recorded and transcribed verbatim for coding and thematic analysis. RESULTS: Twenty participants (age: 42.4 years; female: 50.0%) were interviewed. Participants discussed their experience with NASH symptoms (most frequent: fatigue [75.0%]; weakness/lethargy [70.0%]) and impacts (most frequent: physical and psychological/emotional [70.0% each]; dietary [68.4%]). Participants considered most symptoms to be moderately severe or severe and moderately or highly bothersome. Findings from the TLR and qualitative interviews were incorporated into a conceptual model that describes patient-reported symptoms and impacts of NASH, clinical signs, risk factors, and unmet treatment needs. CONCLUSION: Our study provides insights into patients' perspectives of NASH symptoms and their impact on their daily lives. These findings may guide patient-physician conversations, supporting patient-centered treatment decisions and disease management.

Study findings help to address the gap in current literature about patients' perspectives on NASH and its symptoms as well as its impact on daily life.The study proposes a holistic conceptual model that describes patients' perspectives of living with NASH, including symptoms and their impact, the clinical signs and risk factors of NASH, and the unmet treatment needs of the disease.Healthcare providers can use study findings to inform patient-focused decisions around treatment strategies for NASH.

Clinical, economic, and health-related quality of life outcomes in patients with overweight or obesity in the United States: 2016-2018.

Objectives: This study aimed to estimate clinical, economic (including productivity), and health-related quality of life (HRQoL) outcomes and associated individual characteristics among adults with overweight (OW) or obesity in the United States. Methods: This study included adult respondents with body mass index (BMI) ≥18.5 kg/m2 in the 2017-2018 National Health and Nutrition Examination Survey (NHANES) and 2016 Medical Expenditure Panel Survey. Respondents were classified according to BMI. Individual characteristics were described by BMI categories. Multivariable regression models estimated the association between BMI categories and outcomes, adjusting for individual characteristics. Results: Nearly three-quarters (73.7%) of NHANES participants were OW or obese. Relative to Normal weight (NW), respondents with Class 3 obesity had more obesity-related complications (2.07 vs. 4.62, p < 0.001). Higher BMI was associated with significantly lower HRQoL, lower productivity, and higher healthcare expenditures as well as more frequent weight loss attempts in the previous 12 months. Weight loss surgery and prescription anti-obesity medications (AOMs) were used only by a very small proportion of individuals. Despite frequent weight loss attempts, most respondents did not achieve clinically meaningful weight loss. Conclusions: Adults with OW or obesity experienced worse clinical, economic and HRQoL outcomes than those with NW. Better use of evidence-based obesity treatments, including prescription AOMs, should be considered to achieve more clinically meaningful weight reduction and improved outcomes in individuals with OW or obesity.

Estimating meaningful change for The Impact of Weight on Self-Perception (IW-SP) questionnaire among people with type 2 diabetes.

PURPOSE: The Impact of Weight on Self-perception Questionnaire (IW-SP) is a three-item patient-reported outcome measure (PROM) instrument assessing the impact of body weight on self-perception. To date no published threshold for meaningful change exists. The objective of this study was to estimate the minimal important change (MIC) for the IW-SP among people with type 2 diabetes. METHODS: Responder analyses were conducted using anchor- and distribution-based approaches with existing clinical trial data (SURPASS-2). As SURPASS-2 did not include a priori anchors, a set of alternative exploratory anchors were identified based on the MICs and items from two conceptually related measures used in the trial as well as percent change in body weight. Exploratory anchors with change estimates that were sufficiently related to change in IW-SP (r ≥ 0.30) and were not redundant with other anchors were retained for the MIC analyses. The analyses were conducted in two stages (estimation = 2/3 of sample) to derive initial IW-SP MIC estimates, and a subsequent confirmation stage (remaining 1/3 of sample). RESULTS: While the most conceptually related anchors and items performed best in responsiveness analyses, all anchors resulted in a similar estimate of minimal meaningful change for the IW-SP total score: a 1-point change in raw units (1-5-point scale), corresponding to a 25-point change for transformed scores (0-100 scale). Distribution-based analyses supported these MIC estimates. Results were similar across both stages for all analyses. CONCLUSION: The MIC for the IW-SP for patients with T2D is a 25-point change on the transformed score.

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.

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.

Risk thresholds for patients to switch between daily tablets and biweekly infusions in second-line treatment for advanced hepatocellular carcinoma: a patient preference study.

BACKGROUND: Historically, high hepatocellular carcinoma (HCC)-related mortality has been, in part, due to lack of effective therapies; however, several systemic therapies have been recently approved for HCC treatment, including regorafenib and ramucirumab. These two treatments utilize different routes of administration (four daily tablets and biweekly intravenous infusions, respectively) and have different risks of adverse events (AEs). However, we lack data on patient preferences in balancing the route of administration and risk of AEs in patients with HCC. We aimed to determine patient preferences and trade-offs for second-line treatment in patients with HCC.  METHODS: Patients with advanced or metastatic HCC were recruited through their physicians for this study. Patient preferences were assessed by using a modified threshold technique (TT) design in which respondents were asked two direct-elicitation questions before (assuming same safety and efficacy and only varying mode of administration) and after (incorporating the safety profiles of ramucirumab and regorafenib) the TT series on seven risks of clinically relevant AEs. RESULTS: In total, of the 157 patients recruited by their physicians, 150 were eligible and consented to participate. In the first elicitation question (assuming risk and efficacy were equivalent), 61.3% of patients preferred daily tablets. However, 76.7% of patients preferred the biweekly infusion when the safety profiles of the two available second-line therapies were included. The TT analysis confirmed that preferences for oral administration were not strong enough to balance out the risk of AEs that differentiate the two therapies. DISCUSSION: We found that when patients were asked to choose between a daily, oral medication and a biweekly IV medication for HCC, they were more likely to choose a daily, oral medication if efficacy and safety profiles were the same. However, when risks of AEs representing the safety profiles of two currently available second-line treatments were introduced in a second direct-elicitation question, respondents often selected an IV administration with a safety profile similar to ramucirumab, rather than oral tablets with a safety profile similar to regorafenib. Our findings indicate that the risk profile of a second-line treatment for HCC may be more important than the mode of administration to patients.

Patients' Preferences for Connected Insulin Pens: A Discrete Choice Experiment Among Patients with Type 1 and Type 2 Diabetes.

BACKGROUND: This study quantified how people with diabetes value the unique features of connected insulin pens and related mobile apps, and the underlying reasons for preferring connected versus non-connected insulin pens. METHODS: A discrete choice experiment (DCE) was conducted in the USA and UK to elicit preferences of adults (≥ 18 years) with type 1 or 2 diabetes for attributes of insulin pens. Attributes included device type, dosing support, glucose monitoring, additional app features, and data sharing. Relative attribute importance (RAI) scores were calculated to capture the relative importance of an attribute. Predicted choice probabilities were obtained to compare different profiles for connected and non-connected insulin pens. RESULTS: The DCE was completed by 540 participants (58.9% male; 90.7% Caucasian; mean age, 58.3 years; 69.4% type 2 diabetes). Participants most valued the possibility of using a connected insulin pen with dosing support and automated dose logging (RAI = 39.9%), followed by automatic transfer of glucose levels (RAI = 29.0%), additional features of tracking diet and physical activity (RAI = 14.6%), data sharing (RAI = 13.6%), and device type (RAI = 2.9%). All profiles of connected insulin pens were preferred over a non-connected pen (p < 0.001), and pen profiles with advanced features were preferred over those without (p < 0.001). Preferences differed by age but not diabetes type, country of residence, or insulin regimen. CONCLUSION: People with diabetes in the USA and UK prefer connected over non-connected insulin pens due largely to the availability of automated logging of dose and glucose levels.

A qualitative study to examine meaningful change in physical function associated with weight-loss.

PURPOSE: This study explored perceptions of meaningful weight-loss and the level of change on two patient-reported outcome (PRO) measures, the 36-item Short Form Health Survey® [SF-36v2®] and Impact of Weight on Quality of Life Lite-Clinical Trials© [IWQOL-Lite-CT©], that individuals living with overweight or obesity consider to be meaningful and indicative of treatment success. METHODS: Thirty-three qualitative interviews were conducted in the US with adults living with overweight or obesity. Concept elicitation explored perceptions of minimally important/meaningful weight-loss using open-ended questions. Cognitive debriefing was used to understand thresholds for meaningful change on both measures. RESULTS: Most participants (n = 23/33) expected a 5% total body weight-loss to yield some benefit in physical functioning, while all participants expected a 10% weight-loss to provide a meaningful and noticeable improvement in their physical functioning. Participants indicated that an item-level 1-point score change on each measure would represent a noticeable improvement in physical functioning and indicate treatment success. CONCLUSIONS: Participants expected moderate weight-losses to be noticeable, with ≥ 10% weight-loss yielding the most consistent results. The findings suggested that both measures provide strong opportunity to demonstrate treatment benefit in relation to physical functioning as a small change on the response scale would represent a noticeable improvement in participants' daily lives.

Development of a Measure to Assess Attitudes Towards Nasal versus Autoinjector Glucagon Delivery Devices for Treatment of Severe Hypoglycemia.

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 psychometric properties of a new measure, the Glucagon Device Attitudes Questionnaire (GDAQ), in assessing attitudes toward NG and AI from the perspectives of persons with diabetes on insulin (PWDs), caregivers, and acquaintances. Methods: Developed based on qualitative research, the GDAQ consists of 38 rating items for each device and 16 direct-elicitation of attitudes of device relative to each other. It was administered to participants via a cross-sectional online survey. Twenty-six rating items were included in principal component analysis and confirmatory factor analysis. Items comprising each factor were averaged to form scales. Additionally, 12 direct elicitation items were averaged to form an overall "Attitudes" scale. Reliability and validity analyses were conducted. Descriptive statistics were provided for the rating items not included in the factor analysis. Results: A total of 405 PWDs, 313 caregivers, and 305 acquaintances participated. Three factors were identified: "Prepared and Protected" (7 items), "Hesitation" (12 items), and "Device Perceptions by Others" (7 items); factor loadings ranged from 0.13 to 0.92, 0.50 to 0.89, and 0.16 to 0.92, respectively. Cronbach's alpha for the four scales ranged from 0.76 to 0.96. Correlations of the scales with their global item ranged from 0.30 to 0.90. The items outside of the factor analysis showed good distribution in responses and differentiation between the two devices. Discussion: This study supports the validity and reliability of the GDAQ, which successfully conceptualizes attitudes towards devices for administering glucagon among different respondent groups. Use of the GDAQ can help guide the development and testing of new glucagon drug/device combinations.

Activation, physical activity, and outcomes among individuals with T2D.

OBJECTIVES: To explore the associations among activation, physical activity, hemoglobin A1c (HbA1c), and healthy days in older adults with type 2 diabetes (T2D) who participated in wellness programs. STUDY DESIGN: Observational, longitudinal cohort study utilizing survey, claims, and wellness program data. METHODS: From January to May 2018, individuals enrolled in a commercial or Medicare Advantage and prescription drug plan with T2D (aged 55-89 years) and SilverSneakers or step count data were eligible. Three waves of surveys were mailed (n = 5000) to collect information on activation (Consumer Health Activation Index; Influence, Motivation, and Patient Activation for Diabetes) and health-related quality of life (Healthy Days). Generalized linear models and predictive models evaluated the associations of unhealthy days and HbA1c with physical activity and activation factors. Additional models tested the relationship between physical activity and future acute care visits, accounting for potential confounders via inverse probability of treatment weighting. RESULTS: Respondents to all 3 waves (n = 1147) had higher comorbidity indices but lower HbA1c than individuals with T2D without physical activity data (P < .0001). Individuals with moderate and high activation levels had 67.4% to 74.0% and 71.6% to 85.6% fewer unhealthy days, respectively, than those with lower activation (P < .01). Individuals with high (> 8000/day) step counts at baseline were predicted to have 2.04 fewer unhealthy days/month at follow-up (P < .05) and 0.19% (P < .02) lower HbA1c units, respectively, compared with those with less than 4000 steps per day. High SilverSneakers activity (> 2 activities per week) reduced subsequent acute care visits by 49%. CONCLUSIONS: Increasing patient activation levels encourages physical activity, which can help improve glycemic control and health-related quality of life, especially among older adults.

Use of Connected Pen as a Diagnostic Tool to Evaluate Missed Bolus Dosing Behavior in People with Type 1 and Type 2 Diabetes.

Objective: This study used connected pen to determine missed bolus dose (MBD) frequency during masked and unmasked continuous glucose monitoring (CGM) periods and examined its link with time-in-range (TIR), time-above-range (TAR), time-below-range (TBR), and key participant characteristics in people with diabetes. Methods: This was a 12-week, single-arm, exploratory, two-period study for people with type 1 diabetes (T1D) or type 2 diabetes (T2D). The primary objective was to estimate the average number of MBD during masked and real-time CGM use. The secondary objective was to estimate the average percent TIR and its relationship to MBD. An exploratory objective was to investigate the participant characteristics that were associated with MBD. Data were analyzed for differences in MBD by diabetes type and other participant characteristics, by CGM period, and by hypoglycemic fear scores. Results: Participants (n = 64; T1D, n = 38; T2D, n = 26) were 48 ± 11.9 years old and 44% were female. From the masked to the unmasked period, MBD, %TAR, %TBR, and glycated hemoglobin decreased significantly (0.74 MBD/day to 0.62 MBD/day, P = 0.008; 53.6%-48.1%, P = 0.004; 4.49%-2.93%, P < 0.001; mean 8.8%-8.4%, P < 0.001, respectively), while %TIR increased significantly (41.9%-49.0%, P < 0.001). MBD/day was negatively associated with TIR (P = 0.016) and positively associated with TAR (P = 0.015) for T1D and positively associated with TBR (P = 0.024) for T2D in the masked period only. MBD was significantly associated with fear of hypoglycemia for T2D, but not T1D. Conclusions: MBD is associated with reduced TIR when CGM is masked and tailored therapeutic approaches are needed for T1D and T2D populations.

Satisfaction, Preference and Injection Habits of Switching to 200 Units/ml Insulin Lispro Pen from 100 Units/ml: A Patient Survey in Germany.

INTRODUCTION: The study was designed to assess patient satisfaction, preferences and injection habits for patients using insulin lispro 200 units/ml pen (IL200) compared to their previously used disposable 100 units/ml mealtime insulin pen ("MTI-100 pen") in Germany. METHODS: A site-based, cross-sectional study involving a self-reported survey and medical record extraction in patients with diabetes currently using IL200 for between 3 and 12 months and had previously used any disposable MTI-100 pen. RESULTS: Of 114 patients included, 83.3% were satisfied with IL200 and 3.5% were dissatisfied; 70.2% preferred IL200 over their previous MTI-100 pen and 4.4% preferred their previous MTI-100 pen. The main reasons for IL200 preference were the amount of insulin the pen carries, longer use before discarding, number of non-empty pens discarded, injection volume and frequency replacing pens. Patients discarded (median) 4 IL200 pens per month with 5.3% discarding more than 10 units in their last pen. When insufficient insulin remained to complete a dose, 74.6% injected the remainder and completed with a new pen, 19.3% discarded the pen with remaining insulin, 7.0% saved it for future use and 1.8% left the dose incomplete. CONCLUSIONS: Satisfaction and preference for IL200 was high in this sample of patients using IL200 for 3-12 months. Reasons were consistent with IL200 features, explaining the better patient experience and potential resource saving transitioning from a disposable MTI-100 pen.

Clinical outcomes associated with anti-obesity medications in real-world practice: A systematic literature review.

Anti-obesity medications (AOMs) are efficacious and well tolerated in randomized controlled trials, but findings may not be generalizable to routine clinical practice. This systematic literature review aimed to identify real-world (RW) evidence for AOMs to treat adults ( ≥ 18 years) with obesity or overweight (BMI  ≥  27 kg/m2 ). Searches conducted in MEDLINE, Embase, Health Technology Assessment (HTA) Database, National Health Service (NHS) Economic Evaluation Database, and Cochrane Central Register of Controlled Trials for studies of relevant FDA-approved AOMs yielded 41 publications. Weight loss (WL) was consistently observed, with 14% to 58.6% of patients achieving ≥ 5% WL on orlistat, phentermine/topiramate, naltrexone/bupropion, phentermine, or liraglutide in studies of 3-6 months' duration where this was measured. When cardiometabolic risk factors were assessed, AOMs reduced or had no impact on blood pressure, lipids, or glycemia. RW data on the impact of AOMs on existing obesity-related comorbidities and mortality were generally lacking. AOMs were associated with various adverse events, but these were of mild to moderate severity and no unexpected safety signals were reported. A pattern of poor adherence and persistence with AOMs was observed across studies. Overall, the review confirmed the effectiveness of AOMs in RW settings but demonstrated large gaps in the evidence base.

Antiobesity Medication Use Among Overweight and Obese Adults in the United States: 2015-2018.

OBJECTIVE: To estimate the utilization of U.S. Food and Drug Administration- approved prescription antiobesity medications (AOMs) and to identify factors associated with AOM use in the United States. METHODS: Respondents aged ≥18 years meeting AOM eligibility criteria in the 2015-2016 and 2017-2018 National Health and Nutrition Examination Survey and the 2016 Medical Expenditure Panel Survey were included in the study. AOM eligibility was defined as having a body mass index (BMI) of ≥30 kg/m2 or having a BMI between 27 and 29.9 kg/m2 and at least 1 obesity-related comorbidity. Demographic, socioeconomic, and clinical characteristics, economic outcomes, and health-related quality of life were summarized and compared between AOM users and nonusers. Multivariable logistic regression was used to identify factors that were associated with AOM use. RESULTS: Only 0.80% of eligible adults reported using AOMs in the past 30 days in 2015-2016 and 2017-2018 National Health and Nutrition Examination Survey. A greater proportion of current AOM users previously tried dietary changes compared with nonusers. They also reported an average weight loss of 3.1 kg over the previous year compared with a 1.5-kg gain among the nonusers. The total health care costs trended higher among AOM users, driven mostly by higher outpatient service costs. A BMI of ≥30 kg/m2, depression, dyslipidemia, and infertility predicted AOM use, whereas Medicare and being at risk of sleep apnea were associated with lower odds of AOM use. CONCLUSION: Despite the availability of newer AOMs and their inclusion in medical treatment guidelines, the utilization of AOMs remains low. This may reflect under-prescribing of and/or restricted patient access to approved evidence-based pharmacotherapy for obesity.

EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration.

The EVIDENCE (EValuatIng connecteD sENsor teChnologiEs) checklist was developed by a multidisciplinary group of content experts convened by the Digital Medicine Society, representing the clinical sciences, data management, technology development, and biostatistics. The aim of EVIDENCE is to promote high quality reporting in studies where the primary objective is an evaluation of a digital measurement product or its constituent parts. Here we use the terms digital measurement product and connected sensor technology interchangeably to refer to tools that process data captured by mobile sensors using algorithms to generate measures of behavioral and/or physiological function. EVIDENCE is applicable to 5 types of evaluations: (1) proof of concept; (2) verification, (3) analytical validation, and (4) clinical validation as defined by the V3 framework; and (5) utility and usability assessments. Using EVIDENCE, those preparing, reading, or reviewing studies evaluating digital measurement products will be better equipped to distinguish necessary reporting requirements to drive high-quality research. With broad adoption, the EVIDENCE checklist will serve as a much-needed guide to raise the bar for quality reporting in published literature evaluating digital measurements products.

Understanding the migraine treatment landscape prior to the introduction of calcitonin gene-related peptide inhibitors: Results from the Assessment of TolerabiliTy and Effectiveness in MigrAINe Patients using Preventive Treatment (ATTAIN) study.

BACKGROUND: Calcitonin gene-related peptide (CGRP) inhibitors were introduced in the United States (US) in 2018. To understand the changing patterns of preventive treatment following the introduction of these new agents, we must first characterize the patterns which preceded their introduction. OBJECTIVE: To characterize the burden, unmet need, and treatment patterns in patients with migraine initiating preventive migraine medications before the introduction of CGRP inhibitors in the US. METHODS: Between March 2016 and October 2017, we enrolled episodic (EM) and chronic migraine (CM) patients initiating or changing preventive treatment at primary care or neurology clinic visits in the US, in a real-world observational study using a prospective cohort design. At baseline and monthly thereafter for 6 months, we collected data from study sites and patients on migraine frequency, treatment modifications, migraine impact on functioning, and work productivity for a descriptive analysis of migraine patient experience and treatment patterns. RESULTS: From the sample of 234 completers, 118 had EM (50.4%) and 116 had CM (49.6%). Mean age at enrollment was 41 years (SD = 12) and mean age at first migraine diagnosis was 22 years (SD = 11). Most participants were females (n = 204/234; 87.2%) and white (n = 178/234; 76.1%). The majority (n = 164/234; 70.1%) had not used preventive migraine treatment in the 5 years prior to enrollment (treatment naïve). At baseline, mean monthly migraine days were 9.6 days (SD = 5.0) for the preventive treatment naïve group and 12.4 days (SD = 7.0) for treatment experienced patients. The majority had severe Migraine Disability Assessment (Grade IV, total score ≥21), including 67.1% (n = 110/164) of the preventive treatment naïve and 77.1% (n = 54/70) of the preventive treatment experienced patients. Headache Impact Test total scores indicating severe impairment (score >59) occurred in 88.4% (n = 145/164) of the treatment naïve and 88.6% (n = 62/70) of treatment experienced patients. Mean work productivity loss as measured by the Work Productivity and Activity Impairment questionnaire in the subsample of employed patients was 53.3% loss. The most used acute medications at baseline were nonsteroidal anti-inflammatory agents (n = 124/234; 53.0%), acetaminophen-based products (n = 112/234; 47.9%), and triptans (n = 105/234; 44.9%). The most commonly initiated preventive treatments were topiramate (n = 100/234; 42.7%), tricyclic antidepressants (n = 39/234; 16.7%), beta-blockers (n = 26/234; 11.1%), and onabotulinumtoxinA (n = 24/234; 10.3%). Over the 6-month follow-up period, almost half of patients (n = 116/234, 49.6%) modified their preventive treatment and discontinued treatment (n = 88/312 total modifications; 28.2%) or modified their pattern of use by increasing, decreasing, or skipping doses (n = 224/312 total modifications; 71.8%), often without seeking medical advice. Avoiding side effects was the main reason reported among patients who discontinued (n = 52/88; 59.1%), decreased frequency or dose (n = 37/89; 41.6%), and skipped doses (n = 29/86; 33.7%). Perceived lack of efficacy was another frequent reason reported among those who discontinued (n = 20/88; 22.7%), decreased frequency or dose (n = 15/89; 16.9%), and skipped doses (n = 18/86; 20.9%). Despite initiation of preventive treatment and improvements observed in number of headache and migraine days, migraine patients continued to experience substantial disability, headache impact, and reduced productivity throughout the 6-month follow-up period. CONCLUSIONS: Prior to 2018, the burden of migraine was high for patients initiating preventive treatments. Despite having more than 9 days of migraine per month on average, the majority (70.1%) of patients initiating prevention had been treatment naïve, indicating underuse of preventive treatments. The preventive treatments used in this study were poorly tolerated and were reported by patients to lack efficacy, resulting in suboptimal adherence. The high discontinuation rates suggest that the preventive medications being offered during the period of the study did not meet the treatment needs of patients. In addition, the decisions by about half of patients to alter their prescribed treatment plan without consulting their provider can pose substantial health risks. These findings pertain to the broad set of preventive treatments initiated in this study and do not support inferences about individual preventive treatments, due to limitations in sample size. These findings suggest the need for more effective and better tolerated preventive treatment options.