Jordan E. Pinsker’s research while affiliated with Tandem Diabetes Care, Inc. and other places

Objective: People with diabetes who use the t:slim X2 with Control-IQ technology (CIQ, Tandem Diabetes Care) in the United States also have the option to use the smartphone app (t:connect mobile), which includes the ability to bolus from the app, and continuously upload data to the cloud. This study explores user satisfaction and perceptions of ease of use (EOU) of the smartphone app. Methods: People with type 1 and type 2 diabetes using CIQ completed surveys on satisfaction and perceived EOU of the app after 6 months of use. Data collection occurred June 2023 through November 2023. Results: 3,687 individuals completed surveys at 6 months (54% female, 88% type 1 diabetes, 25% previous MDI users). Of 2,695 who responded to the satisfaction metric, 79.6% were either satisfied or very satisfied with the smartphone app. Of the 2,433 who responded to the EOU metric, 83.6% considered the app “easy” or “very easy” to use. Individuals who use the bolus feature of the app had comparably higher satisfaction and EOU percentages (84% satisfied and 88% EOU) compared to individuals who did not use the bolus feature (69% satisfied, 71% EOU) Conclusion: Users new to Tandem report high satisfaction and EOU for the t:connect mobile smartphone app. The consistently positive perceptions indicates that the CIQ system with the mobile app hold general appeal, potentially assuaging pump hesitancy fears in people not yet using a pump. Disclosure K. Assadi: Employee; Tandem Diabetes Care, Inc. Stock/Shareholder; Tandem Diabetes Care, Inc. M.L. Manning: Employee; Tandem Diabetes Care, Inc. J.E. Pinsker: Employee; Tandem Diabetes Care, Inc. L.H. Messer: Employee; Tandem Diabetes Care, Inc. Funding Tandem Diabetes Care

Introduction & Objective: Adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL) are at risk of iatrogenic hyperglycemia during induction chemotherapy due to exposure to high dose corticosteroids and asparaginase, two cornerstones of ALL therapy. While hyperglycemia has been associated with adverse clinical outcomes, it is often underrecognized and undertreated. We evaluated the use of a hybrid closed-loop (HCL) insulin delivery system in this novel population at risk for severe hyperglycemia. Methods: In this prospective trial, participants with newly diagnosed high-risk ALL received treatment with the Tandem t:slim X2 insulin pump with Control-IQ technology and Dexcom G6 continuous glucose monitor (CGM) during the 5-week chemotherapy induction period. The primary outcome was safety of HCL insulin delivery, as measured by hypoglycemia and adverse device events. Insulin usage and time in range (TIR) were also measured. Results: A total of 5 participants, aged 13-18 years with no history of diabetes, received treatment with HCL insulin delivery. All participants started the system within 2 days after initiation of chemotherapy with high dose corticosteroids and prior to administration of asparaginase. Participants wore the system for a mean of 21 days and CGM for a mean of 23 days. The mean total daily insulin dose was 34.2 ± 24.9 units/day. Mean TIR was 84 ± 13% while on HCL, and mean time below range (TBR) was 0.9% ± 1.2%. One adverse event was related to bleeding at the CGM insertion site, and there were no severe hypoglycemic events. Conclusion: The use of an HCL insulin delivery system for AYA patients with newly diagnosed ALL during induction chemotherapy met all feasibility and safety goals during this pilot trial. Rapid changes in insulin resistance caused by chemotherapy agents require close monitoring and prompt adjustments in HCL settings in this novel population. Disclosure E. Jost: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. S. Cho: None. S. Lange: None. C. Berget: Speaker's Bureau; Dexcom, Inc., Insulet Corporation, embecta. J.E. Pinsker: Employee; Tandem Diabetes Care, Inc. L. Hartman: None. G.P. Forlenza: Research Support; Abbott, Dexcom, Inc. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. Consultant; Insulet Corporation. Research Support; Medtronic. Advisory Panel; Medtronic. Research Support; Tandem Diabetes Care, Inc. Consultant; Tandem Diabetes Care, Inc. Funding Tandem Diabetes and Dexcom Inc.

Objective: The t:slim X2 with Control-IQ technology (CIQ) predicts future hyperglycemia and delivers automatic correction boluses to help improve time-in-range (TIR, 70-180 mg/dl). This is thought to help improve glycemia when users do not initiate boluses for meals. The purpose of this analysis is to determine glycemic results in users who do not bolus for prolonged periods of time. Methods: Data were analyzed from the Tandem Diabetes Care t:connect database for CIQ users from January 2020 to December 2023. Users were included for analysis if they had a minimum of 7/ 14/ 30/ 182 days without a carbohydrate bolus and ≤ 1 manual bolus. Time in range (TIR) and time-below-range (TBR, <70 mg/dl) were analyzed on days without bolusing compared to days with user-initiated boluses. Results: Out of 291,769 CIQ users, 28,790 (10% users) had used the system for 7+ consecutive days without bolusing. The average number of days without boluses was 61 per user. There were a total of 1,728,304 days without boluses in the database. 27,688 users had periods of 7-13 consecutive days without user-initiated boluses. 11,127 users had periods of 14-29 consecutive days without user-initiated boluses. 3,813 users had periods of 30-181 consecutive days without user-initiated boluses. And 102 users had periods of more than 6 months of consecutive days without user-initiated boluses. On days without boluses, median TIR was 62% (IQR 50-74%) in all four groups, whereas median TIR for days with boluses was 57%-60% (IQR 46-70%). The TBR was less than 0.6% for both days without boluses and days with boluses. Conclusion: Users of Control-IQ technology who do not bolus for extended periods of time have slightly higher TIR on days when they do not bolus compared to days when they take manual boluses, with no increase in hypoglycemia. This is likely due to myriad reasons, including that the CIQ system can attenuate hyperglycemia enough to be acceptable for a subset of users who struggle with consistent bolusing. Disclosure M. Polin: Employee; Tandem Diabetes Care, Inc. A.K. Johnson: Employee; Tandem Diabetes Care, Inc. L.H. Messer: Employee; Tandem Diabetes Care, Inc. J.E. Pinsker: Employee; Tandem Diabetes Care, Inc. A. Constantin: Employee; Tandem Diabetes Care, Inc. Funding Tandem Diabetes Care

Objective: To evaluate the safety and explore the efficacy of use of ultra-rapid lispro (URLi, Lyumjev) insulin in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology in children, teenagers, and adults living with type 1 diabetes (T1D). Methods: At 14 U.S. diabetes centers, youth and adults with T1D completed a 16-day lead-in period using lispro in a t:slim X2 insulin pump with Control-IQ 1.5 technology, followed by a 13-week period in which URLi insulin was used in the pump. Results: The trial included 179 individuals with T1D (age 6-75 years). With URLi, 1.7% (3 participants) had a severe hypoglycemia event over 13 weeks attributed to override boluses or a missed meal. No diabetic ketoacidosis events occurred. Two participants stopped URLi use because of infusion-site discomfort, and one stopped after developing a rash. Mean time 70-180 mg/dL increased from 65% ± 15% with lispro to 67% ± 13% with URLi (P = 0.004). Mean insulin treatment satisfaction questionnaire score improved from 75 ± 13 at screening to 80 ± 11 after 13 weeks of URLi use (mean difference = 6; 95% confidence interval 4-8; P < 0.001), with the greatest improvement reported for confidence avoiding symptoms of high blood sugar. Mean treatment-related impact measure-diabetes score improved from 74 ± 12 to 80 ± 12 (P < 0.001), and mean TRIM-Diabetes Device (score improved from 82 ± 11 to 86 ± 12 (P < 0.001). Conclusions: URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with T1D, with quality-of-life benefits of URLi use perceived by the study participants. Clinicaltrials.gov registration: NCT05403502.

Background Customized and standard automated insulin delivery (AID) systems for use in pregnancies of women with pre-existing type 1 diabetes (T1D) are being developed and tested to achieve pregnancy appropriate continuous glucose monitoring (CGM) targets. Guidance on use of CGM for treatment decisions during pregnancy in the US is limited. Methods Ten pregnant women with pre-existing T1D participated in a trial evaluating at-home use of a pregnancy-specific AID system. Seven-point self-monitoring of blood glucose (SMBG) was compared to the closest sensor glucose (CGM-Dexcom G6) value biweekly to assess safety and reliability based on the 20%/20 mg/dL criteria. Results All participants completed the study with seven participants satisfying the safety and reliability criteria with mean absolute relative difference of 10.3%. Three participants did not fulfill criteria mainly because the frequency of SMBG did not meet requirements. Conclusion Dexcom G6 CGM is safe and accurate in the real world setting for use in pregnant women with pre-existing T1D with reduced SMBG testing as part of a pregnancy specific AID system.

Background Control-IQ technology version 1.5 allows for a wider range of weight and total daily insulin (TDI) entry, in addition to other changes to enhance performance for users with high basal rates. This study evaluated the safety and performance of the updated Control-IQ system for users with basal rates >3 units/h and high TDI in a multicenter, single arm, prospective study. Methods Adults with type 1 diabetes (T1D) using continuous subcutaneous insulin infusion (CSII) and at least one basal rate over 3 units/h (N = 34, mean age = 39.9 years, 41.2% female, diabetes duration = 21.8 years) used the t:slim X2 insulin pump with Control-IQ technology version 1.5 for 13 weeks. Primary outcome was safety events (severe hypoglycemia and diabetic ketoacidosis (DKA)). Central laboratory hemoglobin A 1c (HbA 1c ) was measured at system initiation and 13 weeks. Participants continued using glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose transport protein 2 (SGLT-2) inhibitors, or other medications for glycemic control and/or weight loss if on a stable dose. Results All 34 participants completed the study. Fifteen participants used a basal rate >3 units/h for all 24 hours of the day. Nine participants used >300 units TDI on at least one day during the study. There were no severe hypoglycemia or DKA events. Time in range 70-180 mg/dL was 64.8% over the 13 weeks, with 1.0% time <70 mg/dL. Hemoglobin A 1c decreased from 7.69% at baseline to 6.87% at 13 weeks (−0.82%, P < .001). Conclusions Control-IQ technology version 1.5, with wider range of weight and TDI input and enhancements for users with high insulin requirements, was safe in individuals with T1D in this study.

Background Optimization of automated insulin delivery (AID) settings is required to achieve desirable glycemic outcomes. We evaluated safety and efficacy of a computerized system to initialize and adjust insulin delivery settings for the t:slim X2 insulin pump with Control-IQ technology in adults with type 1 diabetes (T1D). Methods After a 2-week continuous glucose monitoring (CGM) run-in period, adults with T1D using multiple daily injections (MDI) (N = 33, mean age 36.1 years, 57.6% female, diabetes duration 19.7 years) were transitioned to 13 weeks of Control-IQ technology usage. A computerized algorithm generated recommendations for initial pump settings (basal rate, insulin-to-carbohydrate ratio, and correction factor) and weekly follow-up settings to optimize glycemic outcomes. Physicians could override the automated settings changes for safety concerns. Results Time in range 70 to 180 mg/dL improved from 45.7% during run-in to 69.1% during the last 30 days of Control-IQ use, a median improvement of 18.8% (95% confidence interval [CI]: 13.6-23.9, P < .001). This improvement was evident early in the study and was sustained over 13 weeks. Time <70 mg/dL showed a gradual decreasing trend over time. Percentage of participants achieving HbA1c <7% went from zero at baseline to 55% at study end ( P < .001). Only six of the 318 automated settings adaptations (1.9%) were overridden by study investigators. Conclusions Computerized initiation and adaptation of Control-IQ technology settings from baseline MDI therapy was safe in adults with T1D. The use of this simplified system for onboarding and optimizing Control-IQ technology may be useful to increase uptake of AID and reduce staff and patient burden in clinical care.