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