Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes.

Background: The Omnipod® 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. Methods: A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110-150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. Results: In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70-180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130-150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL (n = 37,640), median TIR was 65.0% in children and adolescents (2-17 years) and 69.9% in adults (≥18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. Conclusion: These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions.

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.

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.

Identifying solutions to psychological insulin resistance: An international study.

AIMS: To identify actions of healthcare professionals (HCPs) that facilitate the transition to insulin therapy (IT) in type 2 diabetes (T2D) adults. METHODS: Included were T2Ds in seven countries (n = 594) who reported initial IT reluctance but eventually began IT. An online survey included 38 possible HCP actions: T2Ds indicated which may have occurred and their helpfulness. Also reported were delays in IT start after initial recommendation and any period of IT discontinuation. RESULTS: Exploratory factor analysis of HCP actions yielded five factors: "Explained Insulin Benefits" (EIB), "Dispelled Insulin Myths" (DIM), "Demonstrated the Injection Process" (DIP), "Collaborative Style" (CS) and "Authoritarian Style" (AS). Highest levels of helpfulness occurred for DIP, EIB and CS; lowest for AS. Participants who rated DIP as helpful were less likely to delay IT than those who rated DIP as less helpful (OR = 0.75, p = 0.01); participants who rated CS and EIB as helpful were less likely to interrupt IT than those who rated these as less helpful (OR = 0.55, p < 0.01; OR = 0.51, p = 0.01, respectively). CONCLUSIONS: Three key HCP actions to facilitate IT initiation were identified as helpful and were associated with more successful initiation and persistence. These findings may aid the development of interventions to address reluctance to initiating IT.

Key factors for overcoming psychological insulin resistance: an examination of patient perspectives through content analysis.

Objective: To understand participant perceptions about insulin and identify key behaviors of healthcare professionals (HCPs) that motivated initially reluctant adults from seven countries (n=40) who had type 2 diabetes (T2D) to start insulin treatment. Research design and methods: Telephone interviews were conducted with a subset of participants from an international investigation of adults with T2D who were reluctant to start insulin (EMOTION). Questions related to: (a) participants' thoughts about insulin before and after initiation; (b) reasons behind responses on the survey that were either 'not helpful at all' or 'helped a lot'; (c) actions their HCP may have taken to help start insulin treatment; and (d) advice they would give to others in a similar situation of starting insulin. Responses were coded by two independent reviewers (kappa 0.992). Results: Starting insulin treatment was perceived as a negative experience that would be painful and would lead down a 'slippery slope' to complications. HCPs engaged in four primary behaviors that helped with insulin acceptance: (1) showed the insulin pen/needle and demonstrated the injection process; (2) explained how insulin could help with diabetes control and reduce risk of complications; (3) used collaborative communication style; and (4) offered support and willingness to answer questions so that participants would not be 'on their own'. Following initiation, most participants noted that insulin was not 'as bad as they thought' and recommended insulin to other adults with T2D. Conclusions: Based on these themes, two actionable strategies are suggested for HCPs to help people with psychological insulin resistance: (1) demonstrate the injection process and discuss negative perceptions of insulin as well as potential benefits; (2) offer autonomy in a person-centred collaborative approach, but provide support and accessibility to address concerns. These findings help HCPs to better understand ways in which they can engage reluctant people with T2D with specific strategies.

Associated factors that influenced persistence with basal analog insulin therapy among people with type 2 diabetes: An exploratory analysis from a UK real-world sample.

AIM: Real-world effectiveness of insulin therapy is affected by poor treatment persistence, often occurring soon after initiation. An international cross-sectional survey of people with type 2 diabetes mellitus (T2DM) has been conducted to describe reasons for non-persistence with insulin therapy. METHODS: Responders to an online survey in 7 countries were classified as continuers (no gap of ≥7days), interrupters (interrupted therapy for ≥7days within first 6 months, then restarted), and discontinuers (terminated therapy for ≥7days within first 6 months, no restart before survey). We present the results from the United Kingdom (UK) cohort. RESULTS: Of 942 global respondents, 131 were from the UK, having a mean age of 37years and a mean of 7years since first T2DM diagnosis. Reasons contributing to insulin continuation (n=50) were improved physical feeling (52.0%) and improved glycemic control (48.0%). Common reasons for interruption (n=50) or discontinuation (n=31), respectively were weight gain (50.0%, 48.4%) and hypoglycemia (38.0%, 25.8%). Most important reason for possible re-initiation for interrupters and discontinuers, respectively was persuasion by physician/healthcare professional (74.0%, 64.5%). CONCLUSION: The benefits of basal insulin therapy motivated continuers to persist with the treatment; experienced or anticipated side effects contributed to interruption and discontinuation.

Insulin non-persistence among people with type 2 diabetes: how to get your patients to stay on insulin therapy.

Continuing use of medication is key to effective treatment and positive health outcomes, particularly in chronic conditions such as diabetes. However, in primary care, non-persistence (i.e. discontinuing or interrupting treatment) with insulin therapy is a common problem among patients with type 2 diabetes. To help primary care physicians manage patients who are non-persistent or likely not to be persistent, this review aimed to provide an overview of modifiable and non-modifiable factors associated with insulin non-persistence as well as practical strategies to address them. Data were extracted from published studies evaluating factors associated with non-persistence among patients with type 2 diabetes. A targeted literature review was performed using PubMed to identify recent studies (2000-2016) reporting measures of non-persistence with insulin therapy. Practical strategies to identify and prevent non-persistence were based on the authors' direct experience in primary care. Non-modifiable factors associated with non-persistence included gender, age, prior treatments, and cost of therapy. Before/at insulin initiation, modifiable factors included patients' perception of diabetes, preference for oral medication, and concerns/expectations about treatment complexity, inconvenience, or side effects. After initiation, modifiable factors included syringe use, difficulties during the first week of therapy, side effects, and insufficient glycemic control. Open-ended and patient-centered questions and a blame-free environment can help physicians identify, prevent, and reduce non-persistence behaviors. Possible questions to start a conversation with patients are provided. Effective physician-patient communication is essential to the management of diabetes. Primary care physicians should be familiar with the most common reasons for insulin non-persistence.

Initiation of Basal Insulin Analog Treatment for Type 2 Diabetes and Reasons Behind Patients' Treatment Persistence Behavior: Real-World Data from Germany.

BACKGROUND: Poor treatment persistence can affect the real-world effectiveness of insulin therapy. A cross-sectional online survey in 942 patients with type 2 diabetes from 7 different countries evaluated patient experience when initiating basal insulin and the reasons behind insulin persistence patterns. Here, we report the quantitative results for the subset of patients from Germany. METHODS: Adults with type 2 diabetes who had initiated basal insulin during the last 3-24 months, identified from market-research panels, participated in the survey. Patients were asked if they had ≥7-day gaps in basal insulin treatment, and were then classified as "continuers" (no gap since starting insulin), "interrupters" (≥1 gap within the first 6 months after starting insulin and subsequently restarted insulin), or "discontinuers" (stopped insulin within the first 6 months after starting and had not restarted at the time of the survey). For each country, 50 participants were planned per persistence category. Enrollment ended if the target quota was reached or enrollment plateaued. Data were analyzed overall and separately for each persistence cohort. RESULTS: The 131 participants from Germany included 55 (42.0%) continuers, 50 (38.2%) interrupters and 26 (19.9%) discontinuers. The most common motivations to initiate basal insulin therapy were encouragement by physician or other healthcare provider (HCP; 54.2%) and expectation to improve glycemic control (42.0%). More than 95% of participants received training before and during insulin initiation (considered as helpful by 81.7%); most (67.2%) preferred in-person training. Continuers more frequently felt that insulin would help to manage diabetes and that their own views were considered when initiating insulin, they reported less concerns and challenges before and during insulin initiation than interrupters or discontinuers. The most common motivations to continue basal insulin were improved glycemic control (72.7%), improved physical well-being (49.1%), and instruction by physician or other HCP (45.5%). The most common reasons contributing to interruption/discontinuation were perceived weight gain (52.0%/50.0%), hypoglycemia (22.0%/38.5%), and potential adverse effects (30.0%/26.9%). CONCLUSIONS: Quality interactions between physicians or other HCPs and their patients before and during the initiation of basal insulin may help to manage patient expectations and to improve persistence to insulin therapy.

Primary care physician perspectives on basal insulin initiation and maintenance in patients with type 2 diabetes mellitus.

AIMS: To describe primary care physicians' (PCPs) perceptions of patient reactions and concerns about insulin initiation and identify opportunities for increased support. METHODS: Cross-sectional, online survey of PCPs prescribing basal insulin to adults with type 2 diabetes mellitus (T2DM). PCPs were identified from administrative claims of a large commercial health plan and descriptive results of PCP responses were reported. RESULTS: PCPs (N=100) treated an average of 17 patients receiving insulin during a typical week. More than 85% of insulin initiation recommendations originated with PCPs. Most offered glucose monitoring instructions (96%) and advice on diet, exercise, and diabetes management (96%); 35% provided insulin titration algorithms; 93% reported that patients often or always took their insulin daily within 3 months of initiation; 31% of PCPs reported monthly office contacts with patients for the first 3 months; 16% reported no outreach efforts; fewer than 20% connected patients with support groups. When starting basal insulin, PCPs reported patients feeling personal failure regarding their diabetes treatment (33% often/always) and lacking confidence in their ability to manage insulin therapy (38% often/always). CONCLUSIONS: Study results identify additional opportunities for assisting patients in making the transition to insulin, including more frequent direct outreach to monitor insulin usage.

Basal insulin initiation use and experience among people with type 2 diabetes mellitus with different patterns of persistence: results from a multi-national survey.

BACKGROUND AND OBJECTIVE: People with type 2 diabetes mellitus (T2DM) often interrupt basal insulin treatment soon after initiation. This study aimed to describe the experiences during and after basal insulin initiation among people with T2DM with different persistence patterns. METHODS: Adults with T2DM from France, Germany, Spain, UK, US, Brazil, and Japan were identified from consumer panels for an online survey. Respondents who initiated basal insulin 3-24 months prior to survey date were categorized as continuers (no gaps of ≥7 days in insulin treatment); interrupters (first gap ≥7 days within 6 months of initiation and restarted insulin); and discontinuers (stopped insulin for ≥7 days within 6 months of initiation without restarting). RESULTS: Among 942 participants, continuers were older than interrupters and discontinuers (46, 37, and 38 years, respectively, p < .01). Continuers reported having fewer concerns before and after insulin initiation than interrupters and discontinuers, while interrupters had the most concerns. Continuers also reported fewer challenges during the first week of insulin use. Continuers were more likely to respond that insulin use had a positive impact on specific aspects of life than interrupters and discontinuers, for example on glycemic control (73.0%, 63.0%, and 61.8%, respectively; p < .01 vs. continuers). CONCLUSION: Among people with T2DM with different persistence patterns after basal insulin initiation there were significant differences in patient characteristics and experience during and after insulin initiation. Interrupters and discontinuers more frequently reported having concerns and challenges during the initiation process, negative impacts after initiation, and less improvement in glycemic control than continuers.

Correlates of basal insulin persistence among insulin-naïve people with type 2 diabetes: results from a multinational survey.

BACKGROUND AND OBJECTIVE: People with T2DM who initiate basal insulin therapy often stop therapy temporarily or permanently soon after initiation. This study analyzes the reasons for and correlates of stopping and restarting basal insulin therapy among people with T2DM. METHODS: An online survey was completed by 942 insulin-naïve adults with self-reported T2DM from Brazil, France, Germany, Japan, Spain, UK, and US. Respondents had initiated basal insulin therapy within the 3-24 months before survey participation and met criteria for one of three persistence groups: continuers had no gaps of ≥7 days in basal insulin treatment; interrupters had at least one gap in insulin therapy of ≥7 days within the first 6 months after initiation and had since restarted basal insulin; and discontinuers stopped using basal insulin within the first 6 months after initiation and had not restarted. RESULTS: Physician recommendations and cost were strongly implicated in patients stopping and not resuming insulin therapy. Continuous persistence was lower for patients with more worries about insulin initiation, greater difficulties and weight gain while using insulin, and higher for those using pens and perceiving their diabetes as severe. Repeated interruption of insulin therapy was associated with hyperglycemia and treatment burden while using insulin. Resumption and perceived likelihood of resumption were associated with hyperglycemia upon insulin cessation. Perceived likelihood of resumption among discontinuers was associated with perceived benefits of insulin. CONCLUSION: Better understanding of the risk factors for patient cessation and resumption of basal insulin therapy may help healthcare providers improve persistence with therapy.

Association between mild and severe hypoglycemia in people with type 2 diabetes initiating insulin.

AIMS: Primary objective: Identify risk factors associated with severe hypoglycemia (SH) and investigate the association between mild hypoglycemia and SH in people with type 2 diabetes starting insulin. Secondary objectives: Investigate the association of demographics and clinical factors with SH incidence. METHODS: Integrated trial database data were obtained for 3 randomized controlled trials that included insulin-naïve people with type 2 diabetes initiating basal (insulin glargine) versus biphasic (insulin lispro mixture) insulin. Standard definitions were used for SH; mild hypoglycemia was defined as all non-SH. Cox regression identified risk factors associated with SH and the correlation between SH and mild hypoglycemia. RESULTS: Data were pooled (N=2931). During 24-48weeks' treatment, 2127 (72.6%) participants experienced ≥1 mild hypoglycemic event but no SH (mean mild hypoglycemia rate=2.33/month). 56 participants (1.9%) experienced ≥1 SH event plus mild hypoglycemia (mean mild hypoglycemia rate=3.95/month); 748 participants (25.5%) had no hypoglycemia. Among factors tested, only mild hypoglycemia rate/month was associated with SH. SH risk was higher (HR=4.24; 95%CI=2.57-6.99;p<0.0001) for participants experiencing multiple mild hypoglycemic events/month compared with those experiencing ≤1 mild hypoglycemic event/month. CONCLUSIONS: Mild hypoglycemia may predict the first SH event, which is important because SH is a strong and consistent risk factor for morbidity/mortality.

Basal Insulin Persistence, Associated Factors, and Outcomes After Treatment Initiation: A Retrospective Database Study Among People with Type 2 Diabetes Mellitus in Japan.

INTRODUCTION: The objective of this study was to assess basal insulin persistence, associated factors, and economic outcomes for insulin-naïve people with type 2 diabetes mellitus (T2DM) in Japan. METHODS: People aged at least 18 years with T2DM with first claim for basal insulin between May 2006 and April 2013 (index date), no insulin use before index date, and continuous insurance coverage for 6 months before (baseline) and 12 months after index date were selected from the Japan Medical Center Database. On the basis of whether there were at least 30-day gaps in basal insulin treatment, patients were classified as continuers (no gap), interrupters (at least one prescription after gap), and discontinuers (no prescription after gap). A multinomial logistic regression model identified factors associated with persistence. Annual healthcare resource use and costs in the year after initiation were compared between continuers and interrupters and between continuers and discontinuers using propensity score-based inverse probability weighting to adjust for baseline differences. RESULTS: Of the 827 people included (mean age 50 years, ca. 71% male), 36% continued, 42% interrupted, and 22% discontinued basal insulin therapy in the year after initiation. Having at least one inpatient visit and using fewer classes of non-insulin antihyperglycemic medications during baseline were associated with lower likelihoods of continuing therapy. Relative to interrupters and discontinuers, continuers had lower hospitalization rates [continuers, 12.7%; interrupters, 25.4% (p < 0.001); discontinuers, 28.4% (p < 0.001)] and lower inpatient costs [continuers, ¥132,013; interrupters, ¥225,745 (p = 0.054); discontinuers, ¥320,582 (p = 0.036)], but higher pharmacy costs [continuers, ¥158,403; interrupters, ¥134,301 (p = 0.039); discontinuers, ¥121,593 (p = 0.002)] in the year after insulin initiation. Total healthcare costs were similar for the three cohorts. CONCLUSIONS: Substantial proportions of people with T2DM in Japan interrupt or discontinue basal insulin within the year after initiation, and they have higher rates and costs of hospitalizations than patients who continue with their insulin therapy. Further research is needed to understand reasons behind basal insulin persistence and the implications thereof to help clinicians manage T2DM more effectively. FUNDING: Eli Lilly and Company, Boehringer Ingelheim.

Basal insulin persistence, associated factors, and outcomes after treatment initiation among people with type 2 diabetes mellitus in the US.

OBJECTIVE: To assess basal insulin persistence, associated factors, and economic outcomes for insulin-naïve people with type 2 diabetes mellitus (T2DM) in the US. RESEARCH DESIGN AND METHODS: People aged ≥18 years diagnosed with T2DM initiating basal insulin between April 2006 and March 2012 (index date), no prior insulin use, and continuous insurance coverage for 6 months before (baseline) and 24 months after index date (follow-up period) were selected using de-identified administrative claims data in the US. Based on whether there were ≥30 day gaps in basal insulin use in the first year post-index, patients were classified as continuers (no gap), interrupters (≥1 prescription after gap), and discontinuers (no prescription after gap). MAIN OUTCOME MEASURES: Factors associated with persistence - assessed using multinomial logistic regression model; annual healthcare resource use and costs during follow-up period - compared separately between continuers and interrupters, and continuers and discontinuers. RESULTS: Of the 19,110 people included in the sample (mean age: 59 years, ∼60% male), 20% continued to use basal insulin, 62% had ≥1 interruption, and 18% discontinued therapy in the year after initiation. Older age, multiple antihyperglycemic drug use, and injectable antihyperglycemic use during baseline were associated with significantly higher likelihoods of continuing basal insulin. Relative to interrupters and discontinuers, continuers had fewer emergency department visits, shorter hospital stays, and lower medical costs (continuers: $10,890, interrupters: $13,674, discontinuers: $13,021), but higher pharmacy costs (continuers: $7449, interrupters: $5239, discontinuers: $4857) in the first year post-index (p < 0.05 for all comparisons). Total healthcare costs were similar across the three cohorts. Findings for the second year post-index were similar. CONCLUSIONS: The majority of people in this study interrupted or discontinued basal insulin treatment in the year after initiation; and incurred higher medical resource use and costs than continuers. The findings are limited to the commercially insured population in the US. In addition, persistence patterns were assessed using administrative claims as opposed to actual medication-taking behavior and did not account for measures of glycemic control. Further research is needed to understand the reasons behind basal insulin persistence and the implications thereof, to help clinicians manage care for T2DM more effectively.