Patient perspectives and experiences with basal insulin titration in type 2 diabetes in the United States: A cross‐sectional survey

Schulich School of Medicine & Dentistry, University of Western Ontario, London, Ontario, Canada INSERM BMC U1034, Université de Bordeaux, Pessac, France Sanofi, Bridgewater, New Jersey, USA Optum, Eden Prairie, Minnesota, USA The Frist Clinic, Nashville, Tennessee, USA Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany


| INTRODUCTION
The treatment goals for type 2 diabetes (T2D) are to prevent or delay complications and maintain quality of life. This is best achieved through glycaemic management using a patient-centred approach based on careful consideration of individual patient factors and preferences. 1,2 For many people with T2D, addition of long-acting basal insulin (BI) to oral therapy becomes necessary within 5 to 10 years of diagnosis. 1 However, titration following BI initiation is needed to determine the optimal dose for each patient. [1][2][3] Insulin titration is a complex and iterative process that requires enhanced monitoring and tracking of blood glucose and eating behaviour. 3,4 Information about BI titration experience from the perspectives of patients or providers and their correlation to glycaemic control or hypoglycaemic events is limited. This crosssectional survey sought to investigate patients' experience with BI initiation and titration among recent starters of BI treatment to better understand patients' unmet needs.

| MATERIALS AND METHODS
For this observational, cross-sectional survey, US adults with T2D who recently initiated BI were identified through diagnosis and prescription claims from April 2020 through April 2021 from the Optum Research Database during two waves of data collection to achieve an appropriate target sample size (Methods S1, Figure S1). Eligible individuals: had ≥2 T2D diagnosis claims and ≥1 BI prescription claims; were aged ≥18 years at index date (earliest BI prescription claim); had ≥12 months of pre-index continuous enrolment (baseline); had available mailing address and glycated haemoglobin (HbA1c) value (prioritized in Wave 2 only); were willing and able to complete the survey; and had a self-reported T2D diagnosis and confirmation of recent BI  Figure 1A). During BI titration, patients interacted with various HCP types, most commonly every 2 to 3 months ( Figure S3). Most patients were very or extremely satisfied with their HCP's support ( Figure 1B followed by other tools that were used but not captured by the survey ( Figure S4). Almost half of patients were very satisfied with their tracking tools (39% to 45%) and felt very confident in their ability to use tracking tools (40% to 47%).
During BI titration, almost half (49%) of patients experienced hypoglycaemia, of whom 19% experienced severe hypoglycaemia ( Figure 1C). Among those who experienced hypoglycaemia, 32% experienced it while asleep, 33% experienced it once and 32% twice a month ( Figure 1D), and 38% were very confident in managing their titration/adjusting their BI dosage ( Figure 1E). Among patients who

| DISCUSSION
The majority of patients surveyed were offered training and resources in support of BI titration and were very to extremely satisfied with their HCP's support. Patients who tracked diabetes measures used paper logs most often and were satisfied and confident with their tracking tools, as previously reported. 5 However, approximately half of patients in this survey experienced hypoglycaemia during BI titration, including one-third during nighttime, with one-fifth being severe.
Self-reports of hypoglycaemia in real-world settings are usually higher than in clinical trials and close to our findings, 6-9 with a reported range of 37% to 64%. 6 More than half of patients in this survey felt very or extremely confident managing titration/adjusting their BI dose when experiencing hypoglycaemia. While patients' confidence in T2D selfmanagement is encouraging, the high rates of hypoglycaemia that accompany it suggest this perceived confidence may be preventing optimal titration, raising the potential need for optimized communication and titration support tools to foster efficient clinical management.
Potential limitations of this study include a low response rate, although ranges of 20% to 40% have been observed in mail surveys administered among Optum enrollees with various conditions. 10 John White and Valery Walker were responsible for data acquisition and statistical analysis, and had full access to all data. All authors interpreted the data, critically revised, and approved the final version of the manuscript and take responsibility for the integrity of the data and the accuracy of the data analysis.

ACKNOWLEDGMENTS
The authors thank the patients and study investigators for their contributions, as well as Maureen Carlyle for study oversight. This study was funded by Sanofi. Writing and editing assistance, including preparation of a draft manuscript under the direction and guidance of the authors, incorporation of author feedback, and manuscript submission, was provided by Catherine Champagne, PhD (Kay Square Scientific, Newtown Square, PA, USA). This support was funded by Sanofi in accordance with Good Publication Practice (GPP3) guidelines.