Long-Term Improvements in Patient-Reported Outcomes Irrespective of Baseline Glycemic Control and Previous Insulin Delivery Method with the t:slim X2 Insulin Pump with Control-IQ Technology

Harsimran Singh, Gabriel Alencar, Michelle Manning, Kirstin White, Lars Mueller, Jordan Pinsker, Steph Habif, Tandem Diabetes Care

Background

Patient-reported outcomes (PROs) are essential when evaluating patients’ trust in their diabetes therapy and its long-term use. Previous publications from the Control-IQ Observational (CLIO) study (NCT04503174) have shown PRO improvements in people with type 1 diabetes (PWT1D) after three months of using Control-IQ technology.

Methods

We compared PROs at baseline (pre) and 6 months post Control-IQ technology use in CLIO participants. Repeated measures ANOVA was used to assess differences in PROs from pre to post.

Results

Sample included 2062 PWT1D. At baseline, 23% reported HbA1c ≥8.5%, and 63% were using a different insulin pump. After 6 months of Control-IQ technology (post), participants reported significant reduction in the perceived negative impact of diabetes on their diabetes-specific quality of life (mean=4.70 (SD=0.88) vs. 4.40 (1.05), p<0.001) with greatest improvement reported for “freedom to eat as you wish”. Significant improvement in satisfaction with insulin-delivery device (IDD) was noted at post, with participants reporting higher satisfaction with Control-IQ technology (8.84 (1.14) vs. their previous IDD (7.21 (1.97)) (p<0.001). Improved satisfaction was reported across all age groups (e.g., 6–12-year-old: 8.99 (1.01); 65+ years: 8.66 (1.33)). Additionally, reduced burden of diabetes was reported irrespective of previous IDD (MDI: 4.80 (1.85) vs. 3.15 (1.49); Pump users: 4.59 (1.81) vs. 3.10 (1.39); p<0.001) and baseline HbA1c (<8.5%: 4.90 (1.84) vs. 3.05 (1.35); ≥8.5%: 4.88 (1.86) vs. 3.29 (1.50); p<0.001).

Conclusion

Control-IQ technology users reported improved quality of life, reduced diabetes burden, and higher satisfaction with diabetes therapy irrespective of age, baseline HbA1c, and previous IDD.

Responsible Use of Control‑IQ Technology

Even with advanced systems such as Control-IQ technology, users 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 users 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. Because there are situations and emergencies that the system may not be capable of identifying or addressing, users should always pay attention to their symptoms and treat accordingly.

References
1. Haugstvedt A, Hernar I, Strandberg RB, et al. Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: study protocol for the DiaPROM randomised controlled trial pilot study. BMJ Open. 2019;9:e024008.
2. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Fda.gov. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patientreported- outcome-measures-use-medical-product-development-support-labeling-claims. December 2009. Current as of October 2019.
3. Habif S, et al. Quality of life outcomes and glycemic control from the t:slim X2 pump with Control-IQ technology – Real world observations from the CLIO Study. Diabetes Technol Ther. 2021;23(S2):A-66.
4. Holmes-Truscott E, et al. Assessing the perceived impact of diabetes on quality of life: Psychometric validation of the DAWN2 Impact of Diabetes Profile in the second Diabetes MILES – Australia (MILES-2) survey. Diabetes Res Clin Pract. 2019;150:253-263.
5. Manning ML, Singh H, Stoner K, Habif S. The development and psychometric validation of the diabetes impact and device satisfaction scale for individuals with type 1 diabetes. J Diabetes Sci Technol. 2020;14(2):309-317.

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 U-100 insulin only.

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.

Long-Term Improvements in Patient-Reported Outcomes Irrespective of Baseline Glycemic Control and Previous Insulin Delivery Method with the t:slim X2 Insulin Pump with Control-IQ Technology

Background

Methods

Results

Conclusion

Software

Information

Disclosures