A Virtual Training Program for the Tandem t:slim X2 Insulin Pump: Implementation and Outcomes.

Insulin pump training has traditionally been performed in-person. The coronavirus disease 2019 (COVID-19) pandemic necessitated vast increases in the number of virtual pump trainings for Tandem t:slim X2 insulin pump starts. A customized structured pump training curriculum specifically tailored to virtual learning was deployed in early 2020, and included (1) preparation for training with use of the t:simulator app, (2) use of the teach-back method during video training, and (3) automating data uploads for follow-up. Retrospective analysis from >23,000 pump training sessions performed from January 1, 2020 to July 28, 2020 showed sensor time-in-range for up to 6 months after training was 72% (60%-81%) for virtual training versus 67% (54%-78%) for in-person training. Higher user satisfaction (4.78 ± 0.52 vs. 4.64 ± 0.68; P < 0.01) and higher user confidence (4.61 ± 0.75 vs. 4.47 ± 0.0.85; P < 0.01) were reported after the virtual sessions. Virtual pump training was well received and proved safe and effective with the new virtual training curriculum.

Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology.

Background: The t:slim X2™ insulin pump with Control-IQ™ technology, an advanced hybrid closed-loop system, became available in the United States in early 2020. Real-world outcomes with use of this system have not yet been comprehensively reported. Methods: Individuals with type 1 diabetes (T1D) (≥14 years of age) who had ≥21 days of pump usage data were invited via email to participate. Participants completed psychosocial questionnaires (Technology Acceptance Scale [TAS], well-being index [WHO-5], and Diabetes Impact and Devices Satisfaction [DIDS] scale) at timepoint 1 (T1) (at least 3 weeks after starting Control-IQ technology) and the DIDS and WHO-5 at timepoint 2 (T2) (4 weeks from T1). Patient-reported outcomes (PROs) and glycemic outcomes were reviewed at each timepoint. Results: Overall, 9,085 potentially eligible individuals received the study invite. Of these, 3,116 consented and subsequently 1,435 participants completed questionnaires at both T1 and T2 and had corresponding glycemic data available on the t:connect® web application. Time in range was 78.2% (70.2%-85.1%) at T1 and 79.2% (70.3%-86.2%) at T2. PROs reflected high device-related satisfaction and reduced diabetes impact at T2. Factors contributing to high trust in the system included sensor accuracy, improved diabetes control, reduction in extreme blood glucose levels, and improved sleep quality. In addition, participants reported improved quality of life, ease of use, and efficient connectivity to the continuous glucose monitoring system as being valuable features of the system. Conclusions: Continued real-world use of the t:slim X2 pump with Control-IQ technology showed improvements in psychosocial outcomes and persistent achievement of recommended TIR glycemic outcomes in people with T1D.

Real-World Improvements in Hypoglycemia in an Insulin-Dependent Cohort With Diabetes Mellitus Pre/Post Tandem Basal-Iq Technology Remote Software Update.

OBJECTIVE: Software updatable insulin pumps, such as the t:slim X2 pump from Tandem Diabetes Care, enable access to new technology as soon as it is commercialized. The remote software update process allows for minimal interruption in therapy compared to purchasing a new pump; however, little quantitative data exist on the software update process or on pre/post therapeutic outcomes. We examined real-world usage and impact of a remote software updatable predictive low-glucose suspend (PLGS) technology designed to reduce hypoglycemic events in people with insulin-dependent diabetes. METHODS: Approximately 15,000 U.S. Tandem pump users remotely updated their t:slim X2 software to Basal-IQ PLGS technology since its commercial release. We performed a retrospective analysis of users who uploaded at least 21 days of pre/post PLGS update usage data to the Tandem t:connect web application between August 28, 2018, and October 21, 2019 (N = 6,170). Insulin delivery and sensor-glucose values were analyzed per recent international consensus and American Diabetes Association guidelines. Software update performance was also assessed. RESULTS: Median software update time was 5.36 minutes. Overall glycemic outcomes for pre and post software update showed a decrease in sensor time <70 mg/dL from 2.14 to 1.18% (-1.01; 95% confidence interval [CI], -0.97, -1.05; P<.001), with overall sensor time 70 to 180 mg/dL increasing from 57.8 to 58.5% (0.64; 95% CI, 0.04, 1.24; P<.001). These improvements were sustained at 3, 6, and 9 months after the update. CONCLUSION: Introduction of a software updatable PLGS algorithm for the Tandem t:slim X2 insulin pump resulted in sustained reductions of hypoglycemia. ABBREVIATIONS: ADA = American Diabetes Association; CGM = continuous glucose monitoring; CI = confidence interval; PLGS = predictive low-glucose suspend; SG = sensor glucose; T1D = type 1 diabetes; T2D = type 2 diabetes; TIR = time-in-range.

Reducing Hypoglycemia in the Real World: A Retrospective Analysis of Predictive Low-Glucose Suspend Technology in an Ambulatory Insulin-Dependent Cohort.

Objective: Analyze real-world usage and impact of a predictive low-glucose suspend (PLGS) insulin delivery system for maintenance of euglycemia and prevention of hypoglycemic events in people with insulin-dependent diabetes. Methods: Retrospective analysis of Tandem Basal-IQ users who uploaded at least 21 days of PLGS usage data between August 31, 2018, and March 14, 2019 (N = 8132). Insulin delivery and sensor-glucose concentrations were analyzed. The times spent below 70 mg/dL, between 70 and 180 mg/dL, and above 180 mg/dL were assessed. Subgroup analyses were conducted to examine matched pre-/postoutcomes with experienced users (n = 1371) and performance over time for a mixed subgroup with >9 weeks of data (n = 3563). Results: The mean age of patients was 32.4 years, 52% were female, 96% had type 1 diabetes, and 4% had type 2 diabetes. Mean duration on PLGS was 65 days. Algorithm introduction led to a 45% median relative risk reduction in sensor time <70 mg/dL, pre/post (% <70:2.0, 1.1), while the mean glucose remained stable (168 and 168 mg/dL). Mean frequency of hypoglycemic events decreased from one every 9 days to one every 30 days. Total daily insulin dose decreased from 43.4 to 42.3 U in the pre/post subgroup. Manual override of the system was low (4.5%). The number of daily suspensions remained stable (4.9). Conclusions: Introduction of PLGS resulted in effective and sustained prevention of hypoglycemia without a significant increase in mean blood glucose and may be considered for people with type 1 diabetes at risk for hypoglycemia.