BACKGROUND Therapeutic inertia leading to delays in insulin initiation or intensification is a major contributor to lack of optimal diabetes care. This report reviews the literature summarizing data on therapeutic inertia and delays in insulin intensification in the management of type 2 diabetes. METHODS A literature search was conducted of the Allied & Complementary Medicine, BIOSIS Previews, Embase, EMCare, International Pharmaceutical Abstracts, MEDLINE, and ToxFile databases for clinical studies, observational research, and meta-analyses from 2012 to 2022 using search terms for type 2 diabetes and delay in initiating/intensifying insulin. Twenty-two studies met inclusion criteria. RESULTS Time until insulin initiation among patients on two to three antihyperglycemic agents was at least 5 years, and mean A1C ranged from 8.7 to 9.8%. Early insulin intensification was linked with reduced A1C by 1.4%, reduction of severe hypoglycemic events from 4 to <1 per 100 person-years, and diminution in risk of heart failure (HF) by 18%, myocardial infarction (MI) by 23%, and stroke by 28%. In contrast, delayed insulin intensification was associated with increased risk of HF (64%), MI (67%), and stroke (51%) and a higher incidence of diabetic retinopathy. In the views of both patients and providers, hypoglycemia was identified as a primary driver of therapeutic inertia; 75.5% of physicians reported that they would treat more aggressively if not for concerns about hypoglycemia. CONCLUSION Long delays before insulin initiation and intensification in clinically eligible patients are largely driven by concerns over hypoglycemia. New diabetes technology that provides continuous glucose monitoring may reduce occurrences of hypoglycemia and help overcome therapeutic inertia associated with insulin initiation and intensification.

OBJECTIVE The goal of this article was to describe trends in publications (including conference abstracts) and clinical trials that report on glycemic time in range (TIR). DATA SOURCES Reviewed databases included but were not limited to MEDLINE and Embase. Clinical trial registries were also sourced. STUDY SELECTION All studies reporting TIR published between 2010 and 2021 were included. Clinical trials reporting TIR that started in or after 2010 were also included. Non-English publications, abstracts, and clinical trials were excluded. Book chapters, nonhuman studies, and studies not reporting TIR were excluded. DATA EXTRACTION Manuscript/abstract category, publication year, study region, interventional versus observational role of continuous glucose monitoring (CGM), and clinical trial start and completion dates were captured. Glycemic outcomes reported in publications or trials, including TIR as a primary outcome, A1C, time below range (TBR), and time above range (TAR), were also captured. RESULTS A total of 373 clinical trials, 531 publications, and 620 abstracts were included in the review. The number of trials, publications, and abstracts reporting TIR significantly increased, particularly between 2018 and 2021, during which time the number of clinical trials, publications, and conference abstracts reporting TIR increased by sixfold, 12-fold, and 4.5-fold, respectively. About 35–44% of studies reported TIR as a primary outcome. Approximately 54% of clinical trials, 47% of publications, and 47% of conference abstracts reported the role of CGM to be observational. TBR was reported more often than TAR. CONCLUSION The marked increase in the number of trials, publications, and abstracts reporting TIR highlights the increasing significance and acceptance of TIR as an outcome measure in diabetes management.

<p>  </p> <p><strong>Objective. </strong>The goal of this article was to describe trends in publications (including conference abstracts) and clinical trials that report on glycemic time in range (TIR).</p> <p><strong>Data sources.</strong> Reviewed databases included but were not limited to MEDLINE and Embase. Clinical trial registries were also sourced. </p> <p><strong>Study selection.</strong> All studies reporting TIR published between 2010 and 2021 were included. Clinical trials reporting TIR that started in or after 2010 were also included. Non-English publications, abstracts, and clinical trials were excluded. Book chapters, nonhuman studies, and studies not reporting TIR were excluded.</p> <p><strong>Data extraction. </strong>Manuscript/abstract category, publication year, study region, interventional versus observational role of continuous glucose monitoring (CGM), and clinical trial start and completion dates were captured. Glycemic outcomes reported in publications or trials, including TIR as a primary outcome, A1C, time below range (TBR), and time above range (TAR), were also captured. </p> <p><strong>Results. </strong>A total of 373 clinical trials, 531 publications, and 620 abstracts were included in the review. The number of trials, publications, and abstracts reporting TIR significantly increased, particularly between 2018 and 2021, during which time the number of clinical trials, publications, and conference abstracts reporting TIR increased by sixfold, 12-fold, and 4.5-fold, respectively. About 35–44% of studies reported TIR as a primary outcome. Approximately 54% of clinical trials, 47% of publications, and 47% of conference abstracts reported the role of CGM to be observational. TBR was reported more often than TAR.</p> <p><strong>Conclusion. </strong>The marked increase in the number of trials, publications, and abstracts reporting TIR highlights the increasing significance and acceptance of TIR as an outcome measure in diabetes management. </p>

<p>  </p> <p><strong>Objective. </strong>The goal of this article was to describe trends in publications (including conference abstracts) and clinical trials that report on glycemic time in range (TIR).</p> <p><strong>Data sources.</strong> Reviewed databases included but were not limited to MEDLINE and Embase. Clinical trial registries were also sourced. </p> <p><strong>Study selection.</strong> All studies reporting TIR published between 2010 and 2021 were included. Clinical trials reporting TIR that started in or after 2010 were also included. Non-English publications, abstracts, and clinical trials were excluded. Book chapters, nonhuman studies, and studies not reporting TIR were excluded.</p> <p><strong>Data extraction. </strong>Manuscript/abstract category, publication year, study region, interventional versus observational role of continuous glucose monitoring (CGM), and clinical trial start and completion dates were captured. Glycemic outcomes reported in publications or trials, including TIR as a primary outcome, A1C, time below range (TBR), and time above range (TAR), were also captured. </p> <p><strong>Results. </strong>A total of 373 clinical trials, 531 publications, and 620 abstracts were included in the review. The number of trials, publications, and abstracts reporting TIR significantly increased, particularly between 2018 and 2021, during which time the number of clinical trials, publications, and conference abstracts reporting TIR increased by sixfold, 12-fold, and 4.5-fold, respectively. About 35–44% of studies reported TIR as a primary outcome. Approximately 54% of clinical trials, 47% of publications, and 47% of conference abstracts reported the role of CGM to be observational. TBR was reported more often than TAR.</p> <p><strong>Conclusion. </strong>The marked increase in the number of trials, publications, and abstracts reporting TIR highlights the increasing significance and acceptance of TIR as an outcome measure in diabetes management. </p>

Background: HbA1c has traditionally been the gold standard of glycemic control. Continuous glucose monitoring (CGM) has enabled capture of newer glycemic measures such as time in range (TIR) which has been associated with diabetes outcomes, captures glucose variability, and has been endorsed by professional societies. This preliminary analysis describes trends in publications and clinical trials that capture TIR as a clinical outcome. Methods: Systematic review of Embase, MEDLINE, and clinical trial registries was conducted. For each article, year of publication, country of research, role of technology, and funding source were captured. Clinical trials also captured study start dates and anticipated completion dates. Results: TIR was reported in 1561 publications and 401 clinical trials. The number of publications with TIR mentioned grew 12-fold between 2017-2021 (Figure 1) . Among clinical trials capturing TIR, 138 trials were completed between 2010-2020; another 240 have been finished or are estimated to conclude between 2021-2025. Conclusion: TIR as an important clinical outcome continues to proliferate suggesting increasing acceptance of TIR as an emerging standard of care in diabetes management. Further analysis will differentiate studies where CGM was part of the intervention from those where CGM was used to measure outcomes with other interventions. Disclosure P. M. Patel: Employee; Abbott Diabetes. R. Abaniel: None. N. Dogra: Employee; Abbott Diabetes. M. Frazzitta: Employee; Abbott Diabetes, Abbott Diabetes. N. Virdi: Employee; Abbott Diabetes. Funding Abbott Diabetes Care