ORAL PRESENTATION

Abstract

There is mounting evidence supporting the benefits of hybrid closed loop systems for type 1 diabetes (T1D) management. However, published studies lack long-term evaluation of these technologies in ethnically diverse patients including patient-reported outcomes (PROs) assessing lived experiences with these devices.

As part of the Control-IQ Observational (CLIO) study, we evaluated psychosocial outcomes in T1D adults using the Tandem Diabetes Care t:slim X2 insulin pump with Control-IQ technology. Participants completed PRO measures including open-ended items at baseline (pre), 3, 6, and 12 months (post). Wilcox signed rank-test was used to assess differences and qualitative data was analyzed using thematic analysis.

In all, 1306 adult study completers (57.6% female) (White=1084, Hispanic=86, Black=38, Asian=16, Mixed=42) were included in the analysis. Overall, there was a 25.2% improvement in satisfaction with insulin delivery device (IDD) using Control-IQ technology at post (mean=8.83±1.15) vs. pre (i.e., previous IDD) (7.06±2.04) (p<0.001). The Asian cohort reported greater improvement (33.2%) than others. A significant reduction in diabetes impact (33.6%) was noted overall at post (p<0.001) with Hispanic participants reporting greater reduction in diabetes burden (42.8%) than others. For perceived impact of diabetes on quality of life, there was an overall reduction in diabetes impact at post (p<0.001) with Asians showing greater reduction (26.3%) vs. others, specifically in the “freedom to eat as you wish” aspect of life. At post, 71% reported improved sleep quality using Control-IQ technology. Thematic analysis supported these findings highlighting improved diabetes control, quality of life, and ease of use as valuable experiences supporting long-term use of Control-IQ technology. These data demonstrate substantial and sustained psychosocial improvements using Control-IQ technology in diverse ethnic cohorts with T1D.

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Responsible Use of Control-IQ Technology

Even with advanced systems such as the t:slim X2 insulin pump with Control-IQ technology, patients are still responsible for actively managing their diabetes. Control-IQ technology does not prevent all high and low blood glucose events. The system is designed to help reduce glucose variability, but it requires that patients accurately input information, such as meals and periods of sleep or exercise. Control-IQ technology will not function as intended unless all system components, including CGM, infusion sets and pump cartridges, are used as instructed. Importantly, the system cannot adjust insulin dosing if the pump is not receiving CGM readings. Since there are situations and emergencies that the system may not be capable of identifying or addressing, patients should always pay attention to their symptoms and treat accordingly.

References
1. Breton MD, Kovatchev BP. One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology. Diabetes Technol Ther. 2021;23(9):601-608.
2. Barnard K, et al. Patient-Reported Outcomes and Continuous Glucose Monitoring: Can we do better with artificial pancreas devices? Diab Care. 2015;38(5):e70.
3. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Eng J Med. 2019;381(18):1701-1717.
4. Forlenza GP, Breton MD, Kovatchev BP. Candidate selection for Hybrid Closed Loop Systems. Diabetes Technol Ther. 2021;23(11):760-762.
5. Habif S, Singh H, et al. 217-OR: Glycemic Outcomes by Ethnicity in Adults with Type 1 Diabetes Using Control-IQ Technology: Early Results from the CLIO Study. Diabetes. 2021;70(Supplement_1):217-OR.

Important Safety Information

RX ONLY. The t:slim X2 pump and Control-IQ technology are intended for single patient use. The t:slim X2 pump and Control-IQ technology are indicated for use with NovoLog or Humalog U-100 insulin.

t:slim X2 insulin pump : The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled (ACE) pump that is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The t:slim X2 pump is indicated for use in individuals six years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold separately) and ACE pump to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater.

WARNING: Control-IQ technology should not be used by anyone under the age of six years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.

 
Control-IQ technology is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of the t:slim X2 pump and Control-IQ technology must: use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders. The t:slim X2 pump, transmitter, and sensor must be removed before MRI, CT, or diathermy treatment. Visit www.tandemdiabetes.com/safetyinfo for additional important safety information.