Treatment Patterns and Outcomes Before and After Humulin R U-500 Initiation Among US Patients with Type 2 Diabetes Previously Prescribed ≤ 200 Units/day of U-100 Insulin.

INTRODUCTION: Humulin R U-500 (U-500R) utilization has increased in the past few years, raising concerns as U-500R is indicated only for patients requiring > 200 units of insulin. Thus, evidence of dispensed total daily dose (dTDD) > 200 units of prior U-100 insulin based on pharmacy claims is increasingly used as a criterion to determine appropriate switching to U-500R by payers. The study compared the treatment patterns and outcomes before and after U-500R initiation among patients who were identified with ≤ 200 units/day U-100 insulin fill in order to understand the appropriateness of switching. METHODS: Patients with type 2 diabetes who initiated U-500R (index date = first fill) with ≤ 200 units/day pre-index dTDD and > 200 units/day post-index dTDD were identified in a Veterans Health Administration dataset between 1 January 2014 and 30 June 2017. Descriptive analysis was conducted on treatment patterns (dTDD, insulin dosage [units/kg], adherence, number of prescription fills) and clinical outcomes (HbA1c, symptomatic hypoglycemic events). Associations between U-500R exposure and outcomes were evaluated using mixed-effects models. Subgroups of U-500R syringe and KwikPen users were analyzed separately. RESULTS: Among 1191 U-500R initiators identified in the study the mean dTDD increased from the pre- to post-index periods (147.2 vs 346.3; p < 0.0001). The mean HbA1c decreased from pre- to post-initiation (9.6% vs 8.6%; p < 0.0001), and symptomatic hypoglycemia events per patient per year increased (2.0 vs 3.3, p < 0.0001). Mixed-effects models confirmed the significance of the changes (p < 0.0001). Device subgroups followed similar trends. CONCLUSIONS: U-500R initiation was associated with large dTDD increases, improved glycemic control, and modest increases in hypoglycemia events, suggesting U-500R initiation may have corrected previous treatment compliance issues. Imposing dTDDs > 200 units before switching to U-500R criterion could hurt the opportunities for patients who need a simplified regimen for better outcomes.

Treatment Patterns and Outcomes, Before and After Humulin R U-500 Initiation, Among High-Dose Type 2 Diabetes Mellitus Patients in the United States.

OBJECTIVE: Severely insulin-resistant type 2 diabetes (T2D) patients face unique treatment challenges. Humulin R U-500 (U-500R) as insulin monotherapy with both basal/bolus properties addresses these challenges, although it remains understudied. This retrospective study compared real-world patient characteristics, treatment patterns, and outcomes before and after U-500R initiation. METHODS: Adults with T2D on dispensed doses of >180 units/d U-500R monotherapy (index date=first fill) with ≥9-month continuous enrollment both pre- and post-index date and ≥180 units/d insulin pre-index were identified using Veterans Health Administration data (January 1, 2014-January 30, 2017). Overall group was further stratified into elderly and 201 to 300 units dispensed total daily dose (dTDD) subgroups. Syringe and KwikPen users were separately analyzed as subcohorts. Treatment patterns (dTDD), insulin dosage (units/kg), proportion of days covered (PDC) with insulins, and outcomes (HbA1c and hypoglycemic events) were descriptively evaluated, with regression models used to confirm associations between exposure and outcomes. RESULTS: Among 951 U-500R initiators (overall group), mean dTDD (248.5 vs 392.1), percentage of patients with insulin dosage >2 units/kg (38.6% vs 88.1%), and mean PDC (73% vs 77%) significantly increased from the pre- to post-index periods (all P<.001). Changes in HbA1c (9.3% vs 8.5%; P<.0001) and hypoglycemia events per patient per year (2.1 vs 3.1, P<.0001) were statistically significant and confirmed by regression models (P<.0001). Subgroups (elderly, 492; 201 to 300 units, 148) and device subcohorts (syringe, 714; KwikPen, 244) showed similar trends. CONCLUSION: U-500R initiation was associated with significantly improved treatment compliance patterns and glycemic control, with modest increase in hypoglycemia events.

Making sense of glucose metrics in diabetes: linkage between postprandial glucose (PPG), time in range (TIR) & hemoglobin A1c (A1C).

While A1C is the standard diagnostic test for evaluating long-term glucose management, additional glucose data, either from fingerstick blood glucose testing, or more recently, continuous glucose monitoring (CGM), is necessary for safe and effective management of diabetes, especially for individuals treated with insulin. CGM technology and retrospective pattern-based management using various CGM reports have the potential to improve glycemic management beyond what is possible with fingerstick blood glucose monitoring. CGM software can provide valuable retrospective data on Time-in-Ranges (above, below, within) metrics, the Ambulatory Glucose Profile (AGP), overlay reports, and daily views for persons with diabetes and their healthcare providers. This data can aid in glycemic pattern identification and evaluation of the impact of lifestyle factors on these patterns. Time-in-Ranges data provide an easy-to-define metric that can facilitate goal setting discussions between clinicians and persons with diabetes to improve glycemic management and can empower persons with diabetes in self-management between clinic consultation visits. Here we discuss multiple real-life scenarios from a primary care clinic for the application of CGM in persons with diabetes. Optimizing the use of the reports generated by CGM software, with attention to time in range, time below range, and postprandial glucose-induced time above range, can improve the safety and efficacy of ongoing glucose management.

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.

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.

Hot Topics in Primary Care: Demystifying the Differences: Follow-on Biologics, Biosimilars, and Generics.

Sponsors of follow-on biologics can submit their applications for approval by the US Food and Drug Administration (FDA) under 2 distinct pathways. The submission pathway is determined by the pathway previously used by the reference biologic product, which is the biologic product upon which the follow-on product relies for evidence of safety and efficacy.