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.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.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).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.
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.
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.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.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.Better understanding of the risk factors for patient cessation and resumption of basal insulin therapy may help healthcare providers improve persistence with therapy.
Background: Self-monitoring blood glucose (SMBG) values have been used to estimate A1c (eA1c) using the A1c-Derived Average Glucose (ADAG) equation with modifications causing limitations with the results. Our study's objective was to develop new glucose management metrics leveraging real-world SMBG values and checking patterns correlated to lab A1c values.Methods: We conducted a retrospective analysis of data from the Livongo remote management Program for Diabetes. Spearman rank was used to measure the correlation between lab A1c and mean SMBG values by relationship to meals during a 90-day time-period. Using the ADAG equation, mean SBMG metrics were used to generate eA1c values for comparison.Results: There were 815 participants with 906 lab A1c and SMBG values with mean age of 56 years, 54% male, and 10% type 1. Three metrics in Table 1 most correlated (r >= 0.70) to lab A1c had differences of eA1c from -0.5% to -0.6%. Post-meal SMBG had slightly lower correlation (0.66) but with a mean eA1c more similar to the laboratory value.Conclusions: Though real-world SMBG values are correlated to lab A1c values, checking patterns impact the ability of the ADAG equation to estimate A1c. Future work will develop a new linear transformation equation based on meal distribution checking patterns to improve A1c estimation and the ability to leverage SMBG data for real-world evidence generation.View largeDownload slideView largeDownload slide DisclosureM. Perez-nieves: Employee; Self; Eli Lilly and Company. W. Lu: Employee; Self; Teladoc Health. E. Meadows: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. F. Gelsey: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. L. Fan: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. R. James: Employee; Self; Livongo, Teladoc Health, Stock/Shareholder; Self; Livongo, Teladoc Health. B. Shah: Employee; Self; Teladoc Health, Stock/Shareholder; Self; Teladoc Health.
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.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.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%).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.
We report the key factors that motivate reluctant Japanese people with type 2 diabetes (T2D) to initiate insulin treatment.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.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.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.
Background: CGM provide real-time glucose data that allows users to manage their diabetes holistically. This study aimed to assess the association between glycemic control and CGM use in PwT2D-BI. Methods: This retrospective study used IBM MarketScan® 2015 - 2019 Databases to identify PwT2D-BI with (CGM) and without (control) use of CGM. CGM users were followed from first BI until CGM initiation, defined as index date (ID) . The ID of non-CGM controls were randomly assigned based on time between first BI and ID of CGM. . Comparison CGM use for 6 and 12 months were performed using Frequentist Model Averaging (FMA) in a ML framework adjusting for baseline characteristics. Model strategies were applied including matching, weighting, stratification and regression. Results: A total of 5,934 PwT2D-BI (251 CGM; 5,683 control) were included in the study (Table 1) . Observed A1c reduction from baseline to 12 months was 0.87%, 0.95% for 6 and 12 months of CGM use, respectively vs. 0.32% for controls. FMA analyses found CGM users had a statistically significantly greater reduction in A1c both at 6 months (treatment difference 0.30 [0.13,0.48]) and 12 months (0.50 [0.37, 0.72]) . Conclusion: Findings suggest that CGM use for at least 6 months in PwT2D-BI has clinical benefit as demonstrated by A1c reduction in the real-world setting. Disclosure C. Chinthammit: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A. J. M. Brnabic: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. M. Perez-nieves: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company
Recent advances in type 2 diabetes (T2D) care have led to changes in the lived experience of diabetes. Thus, an updated understanding of concomitant changes in diabetes distress (DD) and its measurement is now warranted. Toward this end, we developed a new measurement strategy and instrument to assess DD among adults with T2D: the T2-Diabetes Distress Assessment Tool. Cognitive interviews with a diverse group of 11 T2D adults and 6 diabetes clinicians resulted in the development of 51 items that were administered through an online survey to a validation sample of 599 T2D adults from the TCOYD Research Registry. Included for construct validity were measures of affect (WHO-5, PHQ-8, PSS), hypoglycemic concerns (HABS), self-management (SDSCA), and clinical outcomes (A1C). Item content suggested two broad categories: (1) the core affective experience of DD (T2-DD Core), e.g., feeling overwhelmed with diabetes, and (2) 7 contributors to DD (T2-DD Sources): concerns about hypoglycemia, complications, healthcare provider, management demands, interpersonal issues, shame and stigma, and diabetes care access. The T2-DD Core items and each of the 7 T2-DD Sources items were submitted separately to an EFA with PROMAX rotation. Each analysis yielded a single, dominant factor. Poorly loaded and conceptually overlapping items were removed for parsimony. The final T2-DD Core measure (8 items) and each of the 7 T2-DD Sources measures (22 items in total) yielded acceptable alpha coefficients. T2-DD Core was significantly associated with all construct validity measures; while each of the 7 T2-DD Sources was associated with validity measures in expected areas (e.g., hypoglycemia with HABS). Results were similar for insulin users and non-insulin users. In total, these scales comprise the T2-Diabetes Distress Assessment Tool, which provides a unique method of assessing two complementary and clinically relevant aspects of DD, based on T2D adults’ lived experience: the core level of DD and the specific sources of DD. Disclosure W. H. Polonsky: Advisory Panel; Self; Intarcia Therapeutics, Inc., Consultant; Self; Abbott Diabetes, ADOCIA, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Insulet Corporation, Lilly Diabetes, Novo Nordisk, Onduo LLC., Sanofi US. L. Fisher: Consultant; Self; Ascensia Diabetes Care, Lilly Diabetes, Speaker’s Bureau; Self; Dexcom, Inc. D. M. Hessler: Consultant; Self; Eli Lilly and Company. S. B. King: Consultant; Self; Eli Lilly and Company. U. Desai: Consultant; Self; Eli Lilly and Company. N. Kirson: Consultant; Self; Eli Lilly and Company. M. Perez-nieves: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company
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.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).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).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.
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