Business Wire01.14.20
Tandem Diabetes Care Inc., an insulin delivery and diabetes technology company, has received Health Canada approval of the t:slim X2 insulin pump with Basal-IQ technology. Basal-IQ technology, a predictive low-glucose suspend (PLGS) algorithm, utilizes sensor values from an integrated Dexcom G6 continuous glucose monitor (CGM) to help reduce the frequency and duration of low-glucose events (hypoglycemia). All in-warranty t:slim X2 pump users in Canada will have the option to add Basal-IQ technology to their existing pump free of charge via remote software update in February.1 Tandem expects to begin shipping t:slim X2 pumps with Basal-IQ technology to new customers in the first quarter of 2020.
“The t:slim X2 insulin pump with Basal-IQ technology has received overwhelmingly positive feedback from current users and we are thrilled to bring its benefits to our customers in Canada,” said John Sheridan, president and CEO of Tandem Diabetes Care. “Our ability to provide in-warranty t:slim X2 pump users a software update to add Basal-IQ technology to their current pumps using a personal computer is unparalleled in the industry and further differentiates the t:slim X2 insulin pump from other devices on the market.”
Benefits of Basal-IQ Technology:
Standard Features of the t:slim X2 Insulin Pump:
In a six-week pivotal trial (n=103), a randomized crossover study comparing two three-week periods of at-home insulin pump use, one period using the t:slim X2 pump with Basal-IQ technology, and another period using a CGM-integrated t:slim X2 pump without automated insulin suspension, use of Basal-IQ technology reduced the number of sensor glucose readings below 3.9 mmol/L (70 mg/dL) by 31 percent compared to the control period using a standard CGM-integrated t:slim X2 pump without automated insulin suspension. Importantly, this marked reduction of sensor time below 3.9 mmol/L (70 mg/dL) was accomplished without any increase in the rate of hyperglycemia and participants overwhelmingly described the system as simple to learn and use.5 Data published on real-world use of Basal-IQ technology has demonstrated even greater reductions in time spent below 3.9 mmol/L (70 mg/dL) than seen in the pivotal trial.6
According to Diabetes Canada, there are more than 3.4 million Canadians living with diabetes, of which approximately 10 percent have type 1 diabetes.7 Insulin pumps and diabetes supplies are a covered benefit for qualifying recipients of disability tax credit, assistive devices programs, and qualifying expenses for registered disability savings plans offered in various forms across Canadian provinces.8
Tandem Diabetes Care Inc. is a medical device company dedicated to improving the lives of people with diabetes through innovation and customer experience. The company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Basal-IQ technology. The t:slim X2 pump is capable of remote feature updates using a personal computer and is the only automated insulin delivery device approved for children as young as 6 years old. Tandem is based in San Diego, Calif.
References
1 Additional training is required for this software update.
2 Dexcom G6 CGM readings can be used to make diabetes treatment decisions when taking up to a maximum acetaminophen dose of 1,000mg every six hours. Taking a higher dose may affect the G6 readings.
3 Separate Follow App required.
4 Thirty-eight percent smaller than MiniMed 630G and 670G and at least 28 percent smaller than MiniMed 530G, Animas Vibe and Omnipod System. Data on file, Tandem Diabetes Care.
5 Forlenza GP, Li Z, Buckingham BA, Pinsker JE, 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. DOI:10.2337/dc18-0771.
6 Muller L, Habif S, Leas S, Aronoff-Spencer E. Reducing Hypoglycemia in the Real World: A Retrospective Analysis of Predictive Low-Glucose Suspend Technology in an Ambulatory Insulin-Dependent Cohort. Diab Technol Ther. 2019;21(9):474-484. DOI: 10.1089/dia.2019.0190
7 Estimated diabetes statistics in Canada are generated by the Canadian Diabetes Cost Model; 2015.
8 http://www.diabetes.ca/about-cda/public-policy-position-statements/access-to-diabetes-medication-supplies-medical-devices.
“The t:slim X2 insulin pump with Basal-IQ technology has received overwhelmingly positive feedback from current users and we are thrilled to bring its benefits to our customers in Canada,” said John Sheridan, president and CEO of Tandem Diabetes Care. “Our ability to provide in-warranty t:slim X2 pump users a software update to add Basal-IQ technology to their current pumps using a personal computer is unparalleled in the industry and further differentiates the t:slim X2 insulin pump from other devices on the market.”
Benefits of Basal-IQ Technology:
- Predicts and helps prevent lows—Using Dexcom G6 CGM values, the Basal-IQ feature looks ahead 30 minutes and suspends insulin when glucose is predicted to drop below 4.4 mmol/L (80 mg/dL) or if glucose is currently below 3.9 mmol/L (70 mg/dL). The system resumes insulin once sensor glucose values start to rise.
- No fingersticks—With Dexcom G6 CGM integration, the Basal-IQ feature works with no fingersticks required for mealtime dosing or calibration. Other benefits of the Dexcom G6 CGM include an extended 10-day wear, acetaminophen blocking,2 and the ability to share real-time CGM data with up to 10 followers.3
- Works silently in the background—No additional alerts or alarms are required to use Basal-IQ technology compared to standard CGM-enabled pumps. Users can choose whether or not to receive alerts when insulin is suspended and resumed based on their personal preference.
- No complicated modes to manage—The Basal-IQ feature has no complicated settings to manage and operates without constant input or interaction. The user only has to decide whether they want the feature on or off.
Standard Features of the t:slim X2 Insulin Pump:
- Small and discreet—The t:slim X2 pump is up to 38 percent smaller than other pumps,4 yet can hold up to 300-units of insulin.
- Can be used with or without the Basal-IQ feature or CGM—When advanced features are turned off, the t:slim X2 pump removes the CGM chart from the screen and puts the Bolus and Option buttons front and center for easy access.
In a six-week pivotal trial (n=103), a randomized crossover study comparing two three-week periods of at-home insulin pump use, one period using the t:slim X2 pump with Basal-IQ technology, and another period using a CGM-integrated t:slim X2 pump without automated insulin suspension, use of Basal-IQ technology reduced the number of sensor glucose readings below 3.9 mmol/L (70 mg/dL) by 31 percent compared to the control period using a standard CGM-integrated t:slim X2 pump without automated insulin suspension. Importantly, this marked reduction of sensor time below 3.9 mmol/L (70 mg/dL) was accomplished without any increase in the rate of hyperglycemia and participants overwhelmingly described the system as simple to learn and use.5 Data published on real-world use of Basal-IQ technology has demonstrated even greater reductions in time spent below 3.9 mmol/L (70 mg/dL) than seen in the pivotal trial.6
According to Diabetes Canada, there are more than 3.4 million Canadians living with diabetes, of which approximately 10 percent have type 1 diabetes.7 Insulin pumps and diabetes supplies are a covered benefit for qualifying recipients of disability tax credit, assistive devices programs, and qualifying expenses for registered disability savings plans offered in various forms across Canadian provinces.8
Tandem Diabetes Care Inc. is a medical device company dedicated to improving the lives of people with diabetes through innovation and customer experience. The company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Basal-IQ technology. The t:slim X2 pump is capable of remote feature updates using a personal computer and is the only automated insulin delivery device approved for children as young as 6 years old. Tandem is based in San Diego, Calif.
References
1 Additional training is required for this software update.
2 Dexcom G6 CGM readings can be used to make diabetes treatment decisions when taking up to a maximum acetaminophen dose of 1,000mg every six hours. Taking a higher dose may affect the G6 readings.
3 Separate Follow App required.
4 Thirty-eight percent smaller than MiniMed 630G and 670G and at least 28 percent smaller than MiniMed 530G, Animas Vibe and Omnipod System. Data on file, Tandem Diabetes Care.
5 Forlenza GP, Li Z, Buckingham BA, Pinsker JE, 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. DOI:10.2337/dc18-0771.
6 Muller L, Habif S, Leas S, Aronoff-Spencer E. Reducing Hypoglycemia in the Real World: A Retrospective Analysis of Predictive Low-Glucose Suspend Technology in an Ambulatory Insulin-Dependent Cohort. Diab Technol Ther. 2019;21(9):474-484. DOI: 10.1089/dia.2019.0190
7 Estimated diabetes statistics in Canada are generated by the Canadian Diabetes Cost Model; 2015.
8 http://www.diabetes.ca/about-cda/public-policy-position-statements/access-to-diabetes-medication-supplies-medical-devices.