Initiating hybrid closed loop: A program evaluation of an educator‐led Control‐IQ follow‐up at a large pediatric clinic

Abstract

Background: Control-IQ (Tandem Diabetes) is a hybrid closed-loop (HCL) system that users self-initiate after completing online training. Best practices for clinical followup are not known. Our quality improvement objective was to evaluate the usefulness of an educator-led follow-up program for new HCL users in a type 1 diabetes pediatric clinic.Methods: We implemented an ''HCLCheck-in'' program, first determining when users started HCL, then having diabetes educators contact them for a follow-up call 2-weeks after start. Educators used a Clinical Tool to inform insulin dose and behavior recommendations, and used four benchmarks to determine need for further follow-up: ≥71% HCL use, ≥71% CGM use, ≥60% Time-in-Range (TIR, 70-180 mg/ dL), <5% below 70 mg/dL. Family and educator satisfaction were surveyed.Results: One-hundred-twenty-three youth [mean age 13.6 ± 3.7 y, 53.7% female, mean HbA1c 7.6 ± 1.4% (60 mmol/mol)] completed an HCLCheck-in call a median (IQR) of 18(15, 21) days post-HCL start. 74 users (60%) surpassed benchmarks with 94% HCL use and 71% TIR. Of the 49 who did not, 16 completed a second call, and improved median TIR 12.5% (p = 0.03). HCL users reported high satisfaction with the program overall [median 10 (9, 10) out of 10]. Educators spent a median of 45 (32,70) minutes per user and rated satisfaction with the program as 8 (7,9.5) and the Tool as 9 (9, 10). Conclusion:Our HCLCheck-in program received high satisfaction ratings and resulted in improved TIR for those initially not meeting benchmarks, suggesting users may benefit from early follow-up. Similar programs may be beneficial for other new technologies. K E Y W O R D S hybrid closed loop, pediatrics, program evaluation, quality improvement, type 1 diabetes 1 | INTRODUCTION Diabetes technology options have greatly increased for persons with type 1 diabetes (PWD) in the past decade, with the commercialization of multiple advanced insulin pumps, including hybrid closed-loop (HCL) systems. 1 HCL systems consist of an insulin pump, a connected continuous glucose monitor (CGM), and an algorithm to increase or decrease insulin delivery in response to glucose levels. The most recently available hybrid closed loop system, the t:slim X2 with Control-IQ technology (''Control-IQ'', Tandem Diabetes), was commercially approved in the United States in January 2020 for PWD ages 14 and over and has since been approved for PWD ages 6 and

Effectiveness of a closed‐loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: A prospective, multicentre, real‐life study

“…Unlike scheduled contacts between patients and the diabetes team typical of randomized clinical trials, the children and adolescents who participated in our study were followed up at routine clinical visits every 3 months. The upgrade from Basal‐IQ to Control‐IQ technology was made using a similar approach in all participating centres, adopting a standardized systematic approach as previously reported 4,6 . Indeed, because there are notable differences between semi‐automated systems like Minimed 640G and Control‐IQ, we developed the vEC programme to offer additional educational support by involving children, parents and diabetes teams.…”

“…CLC systems do not fully automate diabetes management but do tend to motivate patients who are committed to maximizing their glucose control 3 . Nevertheless, CLC systems still require motivational and educational input, and the need for adequate education to maximize the benefits of new diabetes technology is well established 4‐6 . A basic level of education is required for most new diabetes technologies, such as the need to count carbohydrates and administer an adequate food bolus well in advance of dosing.…”

“…3 Nevertheless, CLC systems still require motivational and educational input, and the need for adequate education to maximize the benefits of new diabetes technology is well established. [4][5][6] A basic level of education is required for most new diabetes technologies, such as the need to count carbohydrates and administer an adequate food bolus well in advance of dosing. Users of hybrid systems benefit from additional training, because the technology is complex and requires personalized settings including basal rates, insulin correction factors and insulin-to-carbohydrate ratios.…”

Real-World Use of a New Hybrid Closed Loop Improves Glycemic Control in Youth with Type 1 Diabetes

“…Additional clinical followup occurred at our center by diabetes educators during the first few weeks of use, including a structured phone contact with initial data review and assessment. 14 Study participation involved allowing research staff to record glycemic and system use information from device downloads for research purposes, and completing online surveys at baseline, 3 months, and 6 months (survey data not yet published). The Colorado Multiple Institutional Review Board approved this study; young adults and caregivers provided informed consent, and youth provided assent.…”

Trends in Glycemic Control Among Youth and Young Adults With Diabetes: The SEARCH for Diabetes in Youth Study

“…Historically, structured, person-centered, and empowerment-based education programs for diabetes self-management and diabetes technology use have been delivered mostly in-person by a certified diabetes specialist. With the expansion of telehealth services during the coronavirus disease 2019 pandemic, virtual training sessions to provide diabetes education and start diabetes technology have been shown to be feasible (27)(28)(29)(30). The benefits of virtual training can include scheduling flexibility, access to individuals who live in more remote locations, and reaching individuals who experience challenges traveling to appointments and thus help to alleviate health equity issues (29).…”