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SAN DIEGO, Calif.–(BUSINESS WIRE)–Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a number one insulin supply and diabetes know-how firm, at this time introduced constructive real-world knowledge from ongoing use of the t:slim X2™ insulin pump with Management-IQ® superior hybrid closed-loop know-how, demonstrating statistically vital enhancements in glycemic and patient-reported outcomes. Emphasis was positioned on qualitative experiences in addition to insights from numerous populations utilizing the system. The information was introduced this week through the 81st Scientific Classes of the American Diabetes Affiliation.
“Individuals dwelling with diabetes are benefiting from our Management-IQ know-how throughout numerous populations and therapeutic backgrounds, which helps our mission to enhance the lives of individuals dwelling with diabetes,” mentioned John Sheridan, president and CEO of Tandem Diabetes Care. “Along with improved glycemic management, the info introduced this week demonstrated holistic enhancements in individuals’s lives together with decreased diabetes burden and improved high quality of life.”
ADA PRESENTATION SUMMARIES
Glycemic Outcomes by Ethnicity in Adults with Kind 1 Diabetes Utilizing Management-IQ Know-how: Early Outcomes from the CLIO Research
Oral Presentation (217-OR)
Session: Insulin Supply Methods
This presentation reported outcomes from the continued Management-IQ Observational (CLIO) examine evaluating real-world use of the t:slim X2 insulin pump with Management-IQ know-how in numerous teams of individuals with sort 1 diabetes. At baseline, Black contributors reported the very best HbA1c (8.1%) in comparison with contributors from different ethnic cohorts. Utilizing Management-IQ know-how, Glucose Administration Indicator (GMI) at 21 days mirrored vital glycemic enhancements throughout all ethnic teams with Asian contributors displaying the bottom GMI (6.8%) adopted by Caucasian contributors (7.0%). At 21 days, the median sensor time in vary (TIR) of Black contributors (62.7%, IQR=53.4-74.7) was considerably decrease than for Caucasian contributors (75.1%, IQR=70.3-81.0) whereas controlling for age, gender, reported train, annual earnings, and prior remedy. Baseline HbA1c was the important thing issue predicting sensor TIR, adopted by train, annual earnings, and a number of day by day injections (MDI, prior remedy). Disparities in glycemic outcomes throughout socioeconomic and demographic teams recorded at baseline remained after initiating an automatic insulin dosing system. Nonetheless, Management-IQ know-how considerably improved glycemic outcomes for all ethnic teams.
Insulin Supply Patterns Range Throughout Age Teams with Use of Management-IQ Know-how*
Poster Presentation (92-LB)
Class: Scientific Therapeutics/New Know-how—Insulin Supply Methods
— Recipient of the American Diabetes Affiliation’s Diabetes Know-how Curiosity Group 2021 Summary Award within the Class of Scientific Therapeutics/New Know-how—Insulin Supply Methods. —
This presentation reported insulin use on the t:slim X2 pump with Management-IQ know-how from the continued CLIO Research evaluating real-world use of the t:slim X2 insulin pump with Management-IQ know-how in a big, numerous cohort with sort 1 diabetes. Research pattern included 1,499 contributors who had uploaded no less than 21 days of pump knowledge to Tandem’s t:join® net utility and had 75% CGM use throughout this time. Insulin supply through the examine was in comparison with customary formulation for predicting correction issue (CF = 1,800/complete day by day dose) and carbohydrate ratio (CR = 450/complete day by day dose). Outcomes demonstrated that insulin use with the t:slim X2 pump with Management-IQ know-how differed from customary prediction formulation throughout age teams, in that the correction issue prediction issue (CFPF) was considerably larger in kids and youngsters. CFPF was lowest in kids aged 6-9 and in adults aged 66 and above. Further examine is beneficial, with comparability to remaining glycemic outcomes, to find out very best insulin supply settings with Automated Insulin Dosing, as examination of insulin use patterns could help in optimizing outcomes.
* Lead writer, Dr. Jordan Pinsker, is at the moment the Medical Director at Tandem Diabetes Care. This examine was accomplished throughout Dr. Pinsker’s employment at Sansum Diabetes Analysis Institute previous to becoming a member of the corporate.
“I Really feel Human, I Really feel Regular”: A Qualitative Research of Experiences with Management-IQ Know-how in Early Adopters
Poster Presentation (531-P)
Class: Psychosocial, Behavioral Medication
This presentation reported outcomes from qualitative analyses of semi-structured interviews carried out with grownup (N=27) early adopters of Management-IQ know-how to grasp their experiences of initiating and continued use of this know-how. Improved sleep high quality, glycemic management, and sensor time in vary have been widespread themes reported by contributors together with diminished burden of diabetes administration. Total, contributors described worthwhile enhancements of their high quality of life, together with diminished stress and decision-making round diabetes administration, and elevated freedom and spontaneity in day by day life with continued use of Management-IQ know-how.
Actual-World Analysis of Glycemic Outcomes by Prior Remedy for Individuals with Kind 1 and Kind 2 Diabetes Onboarding to Management-IQ Know-how
Poster Presentation (710-P)
Class: Scientific Therapeutics/New Know-how—Insulin Supply Methods
This presentation examined retrospective evaluation of real-world glycemic outcomes by earlier remedy between individuals with sort 1 and sort 2 diabetes over a interval of six months after they onboarded to Management-IQ know-how (excluding people who had undergone a software program replace from a earlier Tandem system). After 180 days of beginning Management-IQ know-how, for prior pump customers with sort 1 diabetes, sensor TIR was 74% (median, IQR 65-81%) and time under <70mg/dL was 1.2% (IQR 0.6-2.1%). For prior pump customers with sort 2 diabetes, sensor TIR was 76% (IQR 69-82%) and time under <70mg/dL was 0.5% (IQR 0.2-1.0%). For contributors transitioning from MDI, Management-IQ know-how resulted in sensor TIR of 74% (IQR 64-83%) and 0.9% time under <70mg/dL (IQR 0.4-1.7%) for individuals with sort 1 diabetes and 74% TIR (IQR 63-84%) and 0.3% time under <70mg/dL (IQR 0.1-0.6%) for individuals with sort 2 diabetes. Utilizing Management-IQ know-how, each sort 1 and sort 2 diabetes contributors (regardless of prior remedy) achieved the beneficial sensor TIR and time under <70mg/dL outcomes.
About Management-IQ Superior Hybrid Closed-Loop Know-how
The t:slim X2 insulin pump with Management-IQ know-how makes use of Dexcom G6 CGM values, at the side of different variables akin to insulin on board, to foretell sensor glucose ranges half-hour forward and modify insulin supply accordingly.1,2,3 Management-IQ know-how is designed to extend sensor time in vary by mechanically growing, lowering, or stopping insulin supply, or giving an computerized correction bolus primarily based on predicted glucose ranges. Management-IQ know-how additionally gives elective settings for sleep and train that can change remedy values to higher match the completely different physiologic wants throughout these actions.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical system firm devoted to bettering the lives of individuals with diabetes by way of relentless innovation and revolutionary buyer expertise. The Firm takes an progressive, user-centric method to the design, improvement, and commercialization of merchandise for individuals with diabetes who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Management-IQ know-how. The t:slim X2 pump is able to distant function updates utilizing a private laptop and is the one automated insulin dosing system accepted for youngsters as younger as six years outdated. Tandem is predicated in San Diego, California.
Accountable Use Assertion
Management-IQ know-how doesn’t stop all excessive and low blood glucose occasions, and isn’t an alternative to meal boluses and lively self-management of diabetes. Management-IQ know-how will be unable to foretell sensor glucose values and modify insulin dosing if a consumer’s CGM will not be working correctly or is unable to speak with their pump. Customers must be instructed to at all times take note of their signs and blood glucose ranges and deal with accordingly. Please go to tandemdiabetes.com/tslimX2-use for extra info.
Essential Security Data: RX ONLY. The t:slim X2 pump and Management-IQ know-how are meant for single affected person use. The t:slim X2 pump and Management-IQ know-how are indicated to be used with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable know-how is an alternate controller enabled (ACE) pump that’s meant for the subcutaneous supply of insulin, at set and variable charges, for the administration of diabetes mellitus in individuals requiring insulin. The pump is ready to reliably and securely talk with appropriate, digitally related units, together with automated insulin dosing software program, to obtain, execute, and make sure instructions from these units. The t:slim X2 pump is indicated to be used in people six years of age and larger. Management-IQ know-how: Management-IQ know-how is meant to be used with a appropriate built-in steady glucose monitor (iCGM, bought individually) and ACE pump to mechanically enhance, lower, and droop supply of basal insulin primarily based on iCGM readings and predicted glucose values. It could possibly additionally ship correction boluses when the glucose worth is predicted to exceed a predefined threshold. Management-IQ know-how is meant for the administration of Kind 1 diabetes mellitus in individuals six years of age and larger.
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WARNING: Management-IQ know-how shouldn’t be utilized by anybody beneath the age of six years outdated. It also needs to not be utilized in sufferers who require lower than 10 models of insulin per day or who weigh lower than 55 kilos. |
Management-IQ know-how will not be indicated to be used in pregnant girls, individuals on dialysis, or critically sick sufferers. Don’t use Management-IQ know-how if utilizing hydroxyurea. Customers of the t:slim X2 pump and Management-IQ know-how should: use the insulin pump, CGM, and all different system elements in accordance with their respective directions to be used; check blood glucose ranges as beneficial by their healthcare supplier; show ample carb-counting abilities; preserve ample diabetes self-care abilities; see healthcare supplier(s) commonly; and have ample imaginative and prescient and/or listening to to acknowledge all features of the pump, together with alerts, alarms, and reminders. The t:slim X2 pump, and the CGM transmitter and sensor have to be eliminated earlier than MRI, CT, or diathermy remedy. Go to tandemdiabetes.com/safetyinfo for added vital security info.
© 2021 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, t:slim X2, Management-IQ, and t:join are both registered logos or logos of Tandem Diabetes Care, Inc. in america and/or different international locations. Dexcom and Dexcom G6 are both registered logos or logos of Dexcom, Inc. in america and/or different international locations. All third-party marks are the property of their respective homeowners.
1 If glucose alerts and CGM readings don’t match signs or expectations, use a blood glucose meter to make diabetes remedy selections.
2 Dexcom G6 CGM bought individually.
3 The Dexcom G6 CGM transmitter can solely be paired with one medical system (both a Dexcom receiver or t:slim X2 pump) and one shopper system (telephone or pill) on the identical time.
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