Abstract

The Control-IQ Observational (CLIO) Study is an ongoing prospective, real-world evaluation of the Tandem Diabetes Care t:slim X2 insulin pump with Control-IQ technology in people with T1D. We assessed baseline HbA1c and Glucose Management Indicator (GMI) derived from sensor data from adult participants who completed the 12-month CLIO study. Adults ages ≥18 years who had ≥75% overall CGM use during this time were included in the analysis. Outcomes were analyzed using a Wilcoxon test.

In all, 1,107 participants (882 prior pump and 225 prior MDI users), median age 41 years (IQR 30-54), 57.2% female met the inclusion criteria. Median GMI was significantly lower at 12 months (7.0% [6.7-7.4]) vs. baseline HbA1c (7.2% [6.7-8.1]) (p<0.0001). Participants ages 18-30 and 46-64 showed the greatest improvement from baseline (0.3% reduction) (p<0.0001), while older adults (≥65-years) showed the lowest GMI at study end (6.9% [6.6-7.2]). Prior MDI users reported higher HbA1c at baseline (7.7% [IQR=6.8-9.0]) vs. prior pumpers (7.2% [6.7-8.0]). However, GMI at 12 months reflected glycemic improvements across all prior therapy modalities (prior MDI=7.0% [6.7-7.3]; prior pump=7.1% [6.7-7.4]) (p<0.0001). This real-world evidence demonstrates significant glycemic improvements with Control-IQ technology in adults, regardless of prior therapy modality, that are sustained long-term across diverse groups of users.

Comparison of baseline HbA1c and GMI at 3,6,9 and 12 months based on prior therapy modality for adult participants in the CLIO study.

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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.