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Introduction

Technology is changing how type 1 diabetes (T1D) is managed. Recent T1D Exchange data indicate that use of technology has increased significantly within the last 3-4 years, particularly in children less than 12 years old. These same data indicate that even so, clinical outcomes worsened over time. Typically, hypoglycemia has been a limiting factor for the attainment of optimal outcomes, however these data demonstrated that incidence of severe hypoglycemia was significantly lower in pump users and trended in the same direction for continuous glucose monitoring (CGM) users. The t:slim X2™ insulin pump with Basal-IQ® technology integrates these two technologies and predicts glucose levels 30 minutes ahead.

Method

De-identified real-world data uploaded to the t:connect® web application (between August 31, 2018 and March 14, 2019) was retrospectively analyzed to assess hypoglycemia outcomes. as measured by continuous glucose monitoring (CGM). The overall group (OG) included 2,696 pediatric users (<18 years; mean blood glucose = 188). Of these, 491 users had sensor-augmented pump data available both pre- and post-predictive low-glucose suspend (PLGS) use.

Results

Pre-post analysis demonstrated a significant reduction in hypoglycemia. Specifically, median time <70 mg/dL decreased from 1.6% to 1.1% upon introduction of Basal-IQ technology. This represents a 31% reduction in hypoglycemia. Sensor time in range (defined as 70-180 mg/dL) remained steady between pre- and post-use of Basal-IQ technology. However, there was a significant decrease in sensor glucose values >300 mg/dL.

Conclusion

Real-world use of Basal-IQ technology is associated with significant reductions in hypoglycemia for pediatric patients. High system reliability and infrequent user overrides reflect high user trust and user comfort with Basal-IQ technology.

t:slim X2 Insulin Pump with Basal-IQ Technology

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Responsible Use of Basal-IQ Technology

Systems like the t:slim X2 insulin pump with Basal-IQ technology are not substitutes for the active management of diabetes. There are common scenarios in which automated systems cannot prevent a hypoglycemic event. The Basal-IQ feature relies on current CGM sensor readings to function and will not be able to predict glucose levels and suspend insulin delivery if a patient’s CGM is not functioning properly or his/her pump is unable to receive the CGM signal. It’s recommended your patient always uses the components of the pump system (pump, cartridges, CGM, and infusion sets) according to the applicable instructions for use and checks them regularly to make sure they are functioning as expected. Patients should always pay attention to their symptoms, actively monitor and manage glucose levels, and treat according to your recommendations.

* Tandem Diabetes Care has a consulting agreement with Jodie M. Ambrosino. † Tandem Diabetes Care.

References:
1. Foster NC, Beck RW, Miller KM, et al. State of type 1 diabetes management and outcomes from the T1D exchange in 2016-2018. Diabetes Technol Ther. 2019;21(2):66-72.
2. Forlenza GP, Li Z, Buckingham BA, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: Results of the PROLOG trial. Diabetes Care. 2018;41(10):2155-2161.
3. Goebel-Fabbri, AE. Disturbed eating behaviors and eating disorders in type 1 diabetes: clinical significance and treatment recommendations. Curr Diab Rep. 2009;9(2):133-139.
4. Jaser SS, Foster NC, Nelson BA, et al. Sleep in children with type 1 diabetes and their parents in the T1D Exchange. Sleep Med. 2017;39:108-115.
5. Caruso NC. Sleep, executive functioning and behaviour in children and adolescents with type 1 diabetes. Sleep Med. 2014;15(12):1490-1499.

Important Safety Information

Caution: Federal (USA) law restricts the t:slim X2 insulin pump and the t:slim X2 insulin pump with Basal-IQ technology to sale by or on the order of a physician. The t:slim X2 insulin pump with Basal-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Basal-IQ technology, and a compatible integrated continuous glucose monitor (iCGM, sold separately). The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The t:slim X2 insulin pump can be used solely for continuous insulin delivery and as part of the System. When used with a compatible CGM, the t:slim X2 insulin pump with Basal-IQ technology can be used to suspend insulin delivery based on CGM sensor readings. The pump and the System are indicated for use in individuals 6 years of age and greater. The pump and the System are intended for single patient use. The pump and the System are indicated for use with NovoLog or Humalog U-100 insulin. The System is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Users of the pump and the System must: be willing and able to 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. The t:slim X2 pump, transmitter, and sensor must be removed before MRI, CT, or diathermy treatment. For additional important safety information, visit www.tandemdiabetes.com/safetyinfo.