Association between continuous glucose monitoring metrics and clinical outcomes in adults with type 1 diabetes in a real-world setting.

AIMS: Continuous glucose monitoring (CGM) metrics can assist diabetes management. Consensus statements recommend > 70 % time in range (TIR) and ≤ 36 % glucose coefficient of variation (CV). However, how these targets perform in clinical practice is unknown. This retrospective, longitudinal cohort study analyzed relationships between TIR, CV, glycated hemoglobin (HbA1c), and hypoglycemia in a real-world setting. METHODS: Data of 542 adults with type 1 diabetes who used CGM (January 2014-July 2020) were analyzed. Associations between TIR and HbA1c at the same and subsequent visits, incidence rate ratios (IRRs) for hypoglycemia at different CVs, and number of hypoglycemic events at cross-sections of HbA1c and CV were estimated by regression. RESULTS: TIR was inversely related to HbA1c; for every 10 % increase in TIR, HbA1c was significantly reduced by 0.34 % (4 mmol/mol) and 0.20 % (2 mmol/mol) at the same and subsequent visits, respectively. Level 2 hypoglycemia was significantly reduced at CV < 30 %, 30-33 %, 33.1-36 %, and 36.1-40 %: adjusted IRRs vs CV ≥ 40.1 % of 0.14, 0.28, 0.32, and 0.50, respectively. Hypoglycemic events were reduced at lower CV across HbA1c levels and at higher HbA1c across CV levels. CONCLUSION: This study quantifies HbA1c improvements with increased TIR and hypoglycemia reductions with improved CV in clinical practice.

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.

Real-World Patterns of Basal Insulin Use with Other Diabetes Medications Among People with Type 2 Diabetes Between 2014 and 2020.

INTRODUCTION: Basal insulin's position in the type 2 diabetes (T2D) treatment paradigm has undergone significant revisions since the advent of diabetes medications such as glucagon-like peptide 1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT-2is), which offer cardiorenal protection for people with T2D (PwT2D). This study aimed to characterize the demographic, clinical, and diabetes medication utilization patterns of PwT2D initiating basal insulin between 2014 and 2020 over the time period when these revisions were occurring. METHODS: A retrospective study was conducted using the IBM® MarketScan® databases and included adults with T2D who initiated basal insulin therapy (basal insulin initiators) in 2015, 2017, or 2019. Patient characteristics, medication utilization patterns, and time to add an additional diabetes drug class were compared across years. Characteristics of users of basal insulin-GLP-1RA combination therapy (GLP-1RA-basal insulin dual users) were also compared across years. RESULTS: Between 2015 and 2019, initiation of basal insulin therapy remained steady, with 1.6-1.9% of PwT2D starting basal insulin in each year. GLP-1RA and SGLT-2i use increased pre- and post-basal insulin initiation (pre-basal: GLP-1RA, from 14.8% to 25.2%, p < 0.0001; SGLT-2i, from 11.4% to 20.5%, p < 0.0001; post-basal: GLP-1RA, from 16.7% to 30.5%, p < 0.0001; SGLT-2i, from 13.4% to 23.3%, p < 0.0001]). The proportion of PwT2D with underlying cardiovascular and renal diseases did not increase during this period. Among basal insulin initiators without prior GLP-1RA, SGLT-2i, or bolus insulin use, time to adding on these agents decreased, with 14.0-15.6% starting bolus insulin within the first year. Among GLP-1RA-basal insulin dual initiators, the proportion of those with underlying cardiovascular disease was not higher among GLP-1RA first users. CONCLUSIONS: In this real-world study, insulin remained key in the T2D treatment paradigm. A growing proportion of PwT2D utilized GLP-1RAs and SGLT-2is before and after initiation of basal insulin therapy. At the same time, there was no increase in the proportion of those initiating basal insulin who had cardiorenal comorbidity profiles for which treatment guidelines have recommended the use of GLP-1RAs or SGLT-2is.

Key factors for overcoming psychological insulin resistance: A qualitative study in Japanese people with type 2 diabetes.

AIMS: We report the key factors that motivate reluctant Japanese people with type 2 diabetes (T2D) to initiate insulin treatment. METHODS: Participants were asked questions pertaining to 2 primary areas of exploration in a concurrent mixed methods approach: (a) understanding people's thoughts and perceptions before and after insulin initiation and any related factors; and (b) exploring the reasons behind people's responses. Data were analyzed using Steps for Coding and Theorization. RESULTS: Participant responses broadly related to 3 themes which influence insulin initiation; 1. Advice from a health care provider (HCP) that insulin is an appropriate treatment; 2. Demonstration by HCPs on how to use the insulin pen/needle and the injection process; and 3. Resignation/surrender/acceptance of insulin, where participants felt there was no other choice but to commence insulin. CONCLUSIONS: Based on the 3 identified themes, it is important for HCPs to explain the benefits of insulin and demonstrate and explain the injection procedure to reluctant Japanese people with T2D. We also identified resignation/surrender/acceptance of insulin as a reason for treatment commencement. This study provides important information to assist HCPs in helping reluctant Japanese people with T2D to initiate basal insulin therapy.

Trends in U.S. Insulin Use and Glucose Monitoring for People with Diabetes: 2009-2018.

BACKGROUND: The delivery and administration of insulin has undergone many changes over the years. This research examines U.S. trends in insulin use among people with type 1 diabetes (T1D) or type 2 diabetes (T2D) in the U.S. from 2009 to 2018. METHODS: The IBM® MarketScan® Commercial and Medicare databases were used to identify trends in insulin use over 10 years. The study included people with T1D or T2D who filled a prescription for insulin in any calendar year from 2009 to 2018. The analyses examined insulin regimen and delivery and the use of glucose monitoring systems. Generalized estimating equations were used to test whether trends were statistically significant. RESULTS: Individuals with T1D were most commonly prescribed a basal and bolus insulin regimen or short/rapid insulin only, while for people with T2D the use of basal-only insulin increased significantly over the study period. In both groups there was a significant decline in the use of premix insulin from 2009 to 2018. Insulin pump use increased for individuals with T1D, while disposable pen use increased for people in both cohorts. In both cohorts, there was a statistically significant increase in the use of continuous glucose monitoring, although this increase was more pronounced and occurred earlier among individuals with T1D. CONCLUSIONS: Results indicate significant changes in insulin regimens and delivery and glucose monitoring from 2009 to 2018. These findings suggest that insulin prescribing continues to change in response to the development of new therapeutics, advances in insulin delivery technology, and glucose monitoring systems.

Toward a more comprehensive understanding of the emotional side of type 2 diabetes: A re-envisioning of the assessment of diabetes distress.

AIMS: To develop an updated, more theoretically sound system for describing and assessing diabetes-related emotional distress (DD) in adults with type 2 diabetes (T2D). METHODS: Items were developed from qualitative interviews with 11 adults with T2D and 6 clinicians, then categorized as reflecting a core emotional experience of DD or a primary source of DD. Items were then administered to a national sample of TCOYD Registry participants. Data were analyzed using both exploratory (EFA) and confirmatory (CFA) factor analyses. Reliability (alpha) and construct validity also were assessed. RESULTS: EFAs with 599 adults (258 insulin users, 341 non-insulin users) yielded a coherent DD Core scale and 7 DD Source scales (management demands, healthcare provider, hypoglycemia, long-term health, interpersonal issues, shame/stigma, healthcare access), which were confirmed by CFA. All alphas were >0.65. DD Core and DD Source scales were associated with criterion variables (all p < .001). Higher DD Core scores were linked to higher HbA1c, BMI, more frequent severe hypoglycemia, and poorer self-management (all p < .001). CONCLUSIONS: Good reliability and validity were found for this two-part T2DD Assessment System. It reflects a more contemporary and actionable approach to DD assessment that distinguishes between its key emotional dimension and its underlying contributors.

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.

Individualized HbA1c target selection and achievement in the Multinational Observational Study Assessing Insulin Use (MOSA1c) type 2 diabetes study.

AIM: To identify which individual-, physician-, and the healthcare system-related factors can predict individualized hemoglobin A1c (HbA1c) targets and the likelihood of reaching those targets after initial insulin therapy over a two-year follow-up period. METHODS: Real-world data, including baseline characteristics of people with type 2 diabetes mellitus (T2DM), psychosocial data, and diabetes medication use, collected from the Multinational Observational Study Assessing Insulin Use (MOSA1c) study in 18 countries were analyzed. RESULTS: Overall, 225 of 1194 people with T2DM (18.8%) who received initial insulin therapy for ≥3 months reached HbA1c targets at two-year follow-up; most were likely to be White (64.9%) and perceptions of their relationship with physicians were less positive than those who did not reach HbA1c targets. Higher baseline HbA1c (>8%) was the strongest predictor of being assigned an HbA1c target >7% (odds ratio [OR] 6.06, 95% confidence interval [CI] 3.97, 9.26). A smaller difference between baseline and target HbA1c levels was the strongest predictor of reaching an HbA1c target at two-year follow-up (large vs small difference, OR 0.28, 95% CI 0.17, 0.47). CONCLUSIONS: Several factors were significantly associated with establishing individualized HbA1c targets and reaching these targets. A small proportion of people with T2DM on insulin therapy reached their HbA1c target. Personalized management of glycemic targets necessitates the adoption of multi-factorial strategies, as several factors could influence an individual's glycemic outcome. CLINICALTRIALS. GOV IDENTIFIER: NCT01400971.

"I've Had an Alarm Set for 3:00 a.m. for Decades": The Impact of Type 1 Diabetes on Sleep.

There is a dearth of research characterizing the impact on a caregiver's sleep when caring for a minor with type 1 diabetes. This study used focus groups of people with type 1 diabetes and caregivers of minors with type 1 diabetes to explore the experience of how diabetes affects sleep. The occurrence of both unanticipated and planned sleep disruptions led to the majority of participants reporting that their sleep was considerably affected by diabetes. Despite the improvement in blood glucose management that diabetes technology devices can provide, people with type 1 diabetes and their caregivers still report sleep disruption and sleep loss resulting from overnight diabetes management.

Overcoming psychological insulin resistance: A practical guide for healthcare professionals.

Despite the demonstrated benefits of using insulin, nearly a third of the patients with type 2 diabetes (T2D) are initially reluctant to initiate insulin therapy when it is first recommended by their healthcare provider (HCP). Several studies have documented the reasons for this phenomenon known as psychological insulin resistance (PIR) and also identified actionable strategies for HCPs to assist people with T2D to overcome their PIR. However, most strategies are based on the experiences of HCPs, rather than of patients. Based on findings from a study exploring real-world patient experience around HCP actions for mitigating PIR, we suggest that HCPs use collaborative strategies throughout the course of T2D treatment to 1) explore reasons for PIR, 2) help patients overcome PIR, and 3) follow-up regarding experience with insulin.

Patient perspectives on the use of half-unit insulin pens by people with type 1 diabetes: a cross-sectional observational study.

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 their perspective. METHODS: An observational cross-sectional online survey was administered through T1D Exchange's online patient community, myGlu.org, to understand the use of half-unit insulin pens. RESULTS: The 278 adult participants (156 EVER, 122 NEVER) had a mean age of 41.8 ± 12.7 years, body mass index of 26.0 ± 3.8 kg/m2, glycated hemoglobin of 6.3% ± 1.0%, and 55% were male. EVER users had T1D for a shorter duration than NEVER users (p < .001). EVER users were less likely to use continuous subcutaneous insulin infusion (p < .001) and more likely to start correcting high blood glucose at a lower level (p < .001) and low blood glucose at a higher level (p < .001). The highest ranked benefits of half-unit pen reported by its current users (N = 131) included prevention of hyperglycemia (40.5%), less anxiety or worry (23.7%), and prevention of hypoglycemia (16.8%). CONCLUSIONS: Half-unit insulin pen is perceived as an insulin device that may help people with T1D to avoid hypo- and hyperglycemic events and decrease their level of disease worry and anxiety. This study highlights the need for patients and health care providers to understand the benefits of half-unit pens while considering options for individualized diabetes management.

An assessment of physician reasons for prescribing Insulin Lispro 200 units/ml in Germany.

OBJECTIVE: To understand physicians' reasons for prescribing Insulin Lispro 200 units/ml (IL200) and their experience with IL200 treatment in Germany. METHODS: The survey consisted of 28 questions on physician's profile, average IL200 patients' characteristics and rationales for prescribing IL200. Questions were rated on a scale of 0 ('not at all important'/'strongly disagree') to 4 ('absolutely important'/'strongly agree'). RESULTS: The surveyed physicians had a mean (SD) experience of 18.1 (7.0) years managing diabetes, consulted an average of 226.8 patients with diabetes/month and prescribed IL200 to 56.1% of their patients on mealtime insulin (MTI). About 80.0% of IL200 patients had type 2 diabetes mellitus, were overweight/obese, and received >20 units/day of MTI. More than 70.0% of physicians rated patient's insulin dose, pattern of self-measured glucose levels, hemoglobin A1c (HbA1c) (clinical); adherence, hypoglycemia knowledge, motivation to improve lifestyle, desire to reduce injection volume and emotional struggle with controlling HbA1c (behavioral) as 'very important'/'absolutely important' factors when prescribing IL200. CONCLUSION: Physicians considered IL200 a promising treatment option that reduces the injection burden for patients on MTI. Physicians adopted a patient-centered perspective by aligning IL200 prescribing decisions with each patient's medical needs and non-clinical preferences, with an aim to encourage treatment adherence through resorting to IL200's advantageous attributes.

Patient characteristics of insulin lispro 200 units/mL users in real world setting in Germany.

OBJECTIVE: Insulin lispro 200 U/mL (IL200) is a treatment choice for people with diabetes who have daily mealtime insulin (MTI) requirements of >20 U/day. We report clinical characteristics of real world IL200 users in Germany to understand clinical settings and the type of patients who would benefit from IL200 treatment. METHODS: This retrospective database analysis used the patient-level data from "IMS Disease Analyzer" in Germany from February 2015 to June 2016. Clinical and demographic information were collected and analyzed for IL200 users alongside that of those who were using more than 20 U a day of 100 U/mL analog MTI. RESULTS: Of the 17,261 patients using insulin, 811 were identified in IL200 group. The IL200 group had 60% men, mean ± SD age of 63.6 ± 11.9 years, and BMI of 36.2 ± 6.7 kg/m2. Of these, 63.5% (n = 515) were seen by diabetologists, while 36.5% (n = 296) were seen by general practitioners (GPs). In the IL200 group, 77.7% used basal insulin concomitantly, >90% had ≥1 comorbidity, and 52% had ≥4 comorbidities; the most common being hypertension (75.2%), neuropathy (66.0%), and nephropathy (59.6%). Diabetologist-treated IL200 users were more likely to have multiple comorbidities as compared with those treated by GPs (15.0% vs. 12.9% for >5 comorbidities). CONCLUSIONS: IL200 is prescribed to people with diabetes who need more than 20 U/day of mealtime insulin and tend to be more obese, older, and with multiple comorbidities. Future research should explore how concentrated MTI can impact adherence and long-term glycemia.

Key Strategies for Overcoming Psychological Insulin Resistance in Adults with Type 2 Diabetes: The UK Subgroup in the EMOTION Study.

INTRODUCTION: Many patients with type 2 diabetes mellitus (T2DM) delay initiation of insulin therapy despite healthcare professional (HCP) advice. This phenomenon has been referred to as 'psychological insulin resistance' (PIR), and various contributing factors have been identified. Studies discussing approaches to overcoming PIR are lacking. Our aim was to identify the key strategies used by HCPs that most helped adults with T2DM and PIR in the UK to initiate insulin. METHODS: As part of a global study, UK adults with T2DM and PIR were recruited (N = 125) to take a survey that included 38 HCP statements and actions about insulin initiation. Data assessed were perceived occurrence and helpfulness of these strategies in facilitating insulin initiation. RESULTS: The most helpful strategies involved demonstrating the injection process (e.g. HCP talked patient through the process of taking insulin [83.6%]) and adopting a collaborative approach (HCP encouraged patient to contact the clinic immediately in case of any problems/questions [80.5%]). Additionally, HCPs highlighting the benefits of insulin (HCP explained that insulin was a natural substance needed by patient's body [81.2%]) and allaying patients' concerns (HCP explained that patient might not have to take insulin forever [78.0%]) helped patients initiate insulin. The least helpful action was HCPs repeatedly persuading patients to initiate insulin (40.9%). CONCLUSIONS: The study recommends key strategies that HCPs can adopt to help adults with T2DM overcome PIR in the UK.

Many patients with type 2 diabetes (T2DM) are reluctant to start insulin therapy despite it being recommended by their doctor. This can lead to a delay in receiving effective treatment to control blood sugar. There are many reasons to explain this reluctance­which is also referred to as psychological insulin resistance (PIR)­including fear of injections and lack of understanding. EMOTION was a global study which set out to identify strategies to overcome PIR. It looked at 38 things, identified by people with diabetes, that doctors/nurses can do or say to encourage a patient to try insulin. Analysis of results for the 125 UK patients with T2DM who were reluctant to start insulin showed that the most helpful approach was demonstrating the injection procedure. Actually talking a patient through how to inject insulin and demonstrating how the pen works can help reduce their fears about the injection process. Adopting a collaborative approach was found to be important, encouraging patients to get in touch with any problems or questions. Other helpful strategies included highlighting the benefits of insulin­explaining that it is a natural substance the body needs­and addressing any specific concerns a patient may have about insulin. The least helpful strategy was taking an authoritarian approach and repeatedly trying to persuade a patient to start insulin. This is the first study which provides evidence-based clinical strategies that UK healthcare professionals can use to help overcome PIR in their patients with T2DM.

Basal Insulin Initiation and Maintenance in Adults with Type 2 Diabetes Mellitus in the United States.

OBJECTIVE: A survey of US adults with type 2 diabetes mellitus was conducted to better understand patients' insulin initiation experiences and treatment persistence behaviors. RESEARCH DESIGN AND METHODS: Participants were recruited from consumer panels and grouped by basal insulin treatment pattern: continuers (no gap of ≥7 days within 6 months of initiation); interrupters (gap ≥7 days, resumed treatment); discontinuers (stopped for ≥7 days, not resumed). A quota of approximately 50 respondents per persistence category was set. RESULTS: A total of 154 respondents (52 continuers, 52 interrupters, 50 discontinuers) completed the survey. Mean age was 51.4 years; 51.9% male. Continuers were more likely to report their views being considered during initiation, and less likely to report a sense of failure. Concerns included insulin dependence (64.3% agree/strongly agree), frequent blood glucose monitoring (55.2%), costs/ability to pay (53.9%), fears of or mistakes during self-injection (52.6%), and weight gain (52.6%). Continuers were motivated by benefits of insulin therapy; experienced or potential side effects were notable factors for interruption/discontinuation. Healthcare provider instruction was indicated as a reason for continuing, stopping, and restarting therapy. CONCLUSION: Benefits of basal insulin therapy motivated continuers while side effects impacted interruption/discontinuation. Persistence on basal insulin is often influenced by provider actions. Earlier provider intervention upon signs of treatment discontinuation may promote persistence.

Successful Health Care Provider Strategies to Overcome Psychological Insulin Resistance in United States and Canada.

PURPOSE: To identify specific actions and characteristics of health care providers (HCPs) in the United States and Canada that influenced patients with type 2 diabetes who were initially reluctant to begin insulin. METHODS: Patients from the United States (n = 120) and Canada (n = 74) were recruited via registry, announcements, and physician referrals to complete a 30-minute online survey based on interviews with patients and providers regarding specific HCP actions that contributed to the decision to begin insulin. RESULTS: The most helpful HCP actions were patient-centered approaches to improve patients' understanding of the injection process (ie, "My HCP walked me through the whole process of exactly how to take insulin" [helped moderately or a lot, United States: 79%; Canada: 83%]) and alleviate concerns ("My HCP encouraged me to contact his/her office immediately if I ran into any problems or had questions after starting insulin" [United States: 76%; Canada: 82%]). Actions that were the least helpful included referrals to other sources (ie, "HCP referred patient to a class to help learn more about insulin" [United States: 40%; Canada: 58%]). CONCLUSIONS: The study provides valuable insight that HCPs can use to help patients overcome psychological insulin resistance, which is a critical step in the design of effective intervention protocols.

Challenges in insulin initiation among Hispanics/Latinos with diabetes in the United States.

PURPOSE: The prevalence of diagnosed diabetes in the United States (U.S.) is particularly high among people of Hispanic/Latino ethnicity, placing this population at risk of developing diabetes-related complications. We conducted a systematic literature review to understand and communicate the current gaps and disparities, including myths and misconceptions, regarding insulin initiation among the Hispanic/Latino population in the U.S. METHODS: We searched MEDLINE and MEDLINE In-process, e-pubs ahead of print (OvidSP), EMBASE (OvidSP), and the Cochrane Central Register of Controlled Trials (CENTRAL). The search strategy combined free text and controlled vocabulary terms and was developed to identify challenges associated with insulin use and initiation, as well as myths/misconceptions associated with insulin use. The quality of included studies was assessed using the National Institutes of Health (NIH) quality assessment tool. PRINCIPAL RESULTS: In total, 777 articles were identified, with 13 articles included for data synthesis. Frequently reported barriers to initiating diabetes treatment among the Hispanic/Latino community related to socioeconomic and sociocultural factors. In particular, limited health literacy and access to health care, as well as low education and economic status, were common factors preventing treatment initiation for diabetes. Cultural factors, including language, food preferences, and lack of family support were also evident, with misconceptions and fears concerning insulin being commonly reported. Patients also described barriers concerning health care providers, including interpersonal issues and difficulties with communication and language. MAJOR CONCLUSIONS: Overall, the current literature highlights many obstacles facing Hispanic/Latino patients in initiating insulin treatment for diabetes. Although limited research was identified, we describe common barriers and themes among this minority population. Awareness of these barriers is important for health care providers, enabling them to identify and address insulin-related fears and misconceptions and to be mindful of their cultural competency. Additionally, knowledge of current barriers will guide further research aimed at developing tailored strategies and tools to improve long-term health outcomes and quality of life in this population.

Patient Preferences and Health State Utilities Associated with Mealtime Insulin Concentrations Among Patients with Diabetes in Italy.

INTRODUCTION: Standard concentration (100 units/mL) mealtime insulin is frequently used to treat patients with type 1 (T1D) and type 2 diabetes (T2D). A more concentrated version of the medication (200 units/mL) has been available in Italy since 2016. This concentrated version is bioequivalent to the standard version and delivers the same amount of medication but in half the volume of liquid. The purpose of this study was to examine patient preferences and estimate health state utilities associated with standard and concentrated rapid-acting mealtime analog insulin. METHODS: Participants with T1D and T2D in Italy valued two health states in time trade-off interviews. The descriptions of diabetes and treatment in the two health states were identical, differing only in terms of insulin concentration (e.g., half as much liquid for the same dose, less effort needed to press the injection button, and fewer injection pens required with concentrated insulin). To ensure participants understood the health states, they were shown a short video illustrating the differences between concentrations. RESULTS: A total of 217 participants completed the interviews (49.8% male; mean age 56.1 years; 109 from Milan; 108 from Rome; 12.0% T1D; 88.0% T2D). When asked which health state they preferred, 98.2% responded the concentrated version, 0.9% said the standard version, and 0.9% had no preference. Mean [standard deviation (SD)] utilities rounded to three decimals were 0.892 (0.099) for the concentrated version and 0.884 (0.101) for the standard version. The mean (SD; p value) utility difference between the standard and concentrated rapid-acting insulin was 0.007 (0.019; p < 0.0001). CONCLUSIONS: Findings from this study provide insight into patient preferences associated with concentration of rapid-acting insulin. Although the difference in utility is small, patients consistently preferred the concentrated formulation over the standard insulin, and for some patients this difference had an impact on utility valuations. These results suggest that the concentration of rapid-acting insulin should be considered because it could affect treatment preference and quality of life. FUNDING: Eli Lilly and Company.