SAN DIEGO, Calif.–(BUSINESS WIRE)–Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a number one insulin supply and diabetes expertise firm, immediately offered optimistic real-world information from ongoing use of the t:slim X2™ insulin pump with Management-IQ® superior hybrid closed-loop expertise, demonstrating statistically important enhancements in glycemic and patient-reported outcomes. Emphasis was positioned on qualitative experiences in addition to insights from various populations utilizing the system. The information was offered this week through the 81st Scientific Periods of the American Diabetes Affiliation.
“Folks dwelling with diabetes are benefiting from our Management-IQ expertise throughout various populations and therapeutic backgrounds, which helps our mission to enhance the lives of individuals dwelling with diabetes,” stated John Sheridan, president and CEO of Tandem Diabetes Care. “Along with improved glycemic management, the information offered 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 Expertise: Early Outcomes from the CLIO Research
Oral Presentation (217-OR)
Session: Insulin Supply Techniques
This presentation reported outcomes from the continuing Management-IQ Observational (CLIO) examine evaluating real-world use of the t:slim X2 insulin pump with Management-IQ expertise in various 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 expertise, Glucose Administration Indicator (GMI) at 21 days mirrored important 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 revenue, and prior remedy. Baseline HbA1c was the important thing issue predicting sensor TIR, adopted by train, annual revenue, and a number of every 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. Nevertheless, Management-IQ expertise considerably improved glycemic outcomes for all ethnic teams.
Insulin Supply Patterns Differ Throughout Age Teams with Use of Management-IQ Expertise*
Poster Presentation (92-LB)
Class: Scientific Therapeutics/New Expertise—Insulin Supply Techniques
— Recipient of the American Diabetes Affiliation’s Diabetes Expertise Curiosity Group 2021 Summary Award within the Class of Scientific Therapeutics/New Expertise—Insulin Supply Techniques. —
This presentation reported insulin use on the t:slim X2 pump with Management-IQ expertise from the continuing CLIO Research evaluating real-world use of the t:slim X2 insulin pump with Management-IQ expertise in a big, various cohort with sort 1 diabetes. Research pattern included 1,499 contributors who had uploaded no less than 21 days of pump information to Tandem’s t:join® internet utility and had 75% CGM use throughout this time. Insulin supply through the examine was in comparison with normal formulation for predicting correction issue (CF = 1,800/whole every day dose) and carbohydrate ratio (CR = 450/whole every day dose). Outcomes demonstrated that insulin use with the t:slim X2 pump with Management-IQ expertise differed from normal prediction formulation throughout age teams, in that the correction issue prediction issue (CFPF) was considerably better in kids and youngsters. CFPF was lowest in kids aged 6-9 and in adults aged 66 and above. Extra examine is really helpful, with comparability to closing glycemic outcomes, to find out splendid 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 Expertise in Early Adopters
Poster Presentation (531-P)
Class: Psychosocial, Behavioral Drugs
This presentation reported outcomes from qualitative analyses of semi-structured interviews carried out with grownup (N=27) early adopters of Management-IQ expertise to grasp their experiences of initiating and continued use of this expertise. Improved sleep high quality, glycemic management, and sensor time in vary had been frequent themes reported by contributors together with diminished burden of diabetes administration. Total, contributors described beneficial enhancements of their high quality of life, together with diminished stress and decision-making round diabetes administration, and elevated freedom and spontaneity in every day life with continued use of Management-IQ expertise.
Actual-World Analysis of Glycemic Outcomes by Prior Remedy for Folks with Kind 1 and Kind 2 Diabetes Onboarding to Management-IQ Expertise
Poster Presentation (710-P)
Class: Scientific Therapeutics/New Expertise—Insulin Supply Techniques
This presentation examined retrospective evaluation of real-world glycemic outcomes by earlier remedy between individuals with sort 1 and kind 2 diabetes over a interval of six months after they onboarded to Management-IQ expertise (excluding people who had undergone a software program replace from a earlier Tandem system). After 180 days of beginning Management-IQ expertise, for prior pump customers with sort 1 diabetes, sensor TIR was 74% (median, IQR 65-81%) and time beneath <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 beneath <70mg/dL was 0.5% (IQR 0.2-1.0%). For contributors transitioning from MDI, Management-IQ expertise resulted in sensor TIR of 74% (IQR 64-83%) and 0.9% time beneath <70mg/dL (IQR 0.4-1.7%) for individuals with sort 1 diabetes and 74% TIR (IQR 63-84%) and 0.3% time beneath <70mg/dL (IQR 0.1-0.6%) for individuals with sort 2 diabetes. Utilizing Management-IQ expertise, each sort 1 and kind 2 diabetes contributors (no matter prior remedy) achieved the really helpful sensor TIR and time beneath <70mg/dL outcomes.
About Management-IQ Superior Hybrid Closed-Loop Expertise
The t:slim X2 insulin pump with Management-IQ expertise makes use of Dexcom G6 CGM values, along with different variables reminiscent of insulin on board, to foretell sensor glucose ranges half-hour forward and regulate insulin supply accordingly.1,2,3 Management-IQ expertise is designed to extend sensor time in vary by robotically growing, reducing, or stopping insulin supply, or giving an computerized correction bolus primarily based on predicted glucose ranges. Management-IQ expertise additionally gives elective settings for sleep and train that can change remedy values to higher match the totally different physiologic wants throughout these actions.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical gadget firm devoted to bettering the lives of individuals with diabetes by relentless innovation and revolutionary buyer expertise. The Firm takes an progressive, user-centric strategy to the design, growth, and commercialization of merchandise for individuals with diabetes who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Management-IQ expertise. The t:slim X2 pump is able to distant characteristic updates utilizing a private pc and is the one automated insulin dosing gadget authorised for youngsters as younger as six years previous. Tandem relies in San Diego, California.
Accountable Use Assertion
Management-IQ expertise doesn’t stop all excessive and low blood glucose occasions, and isn’t an alternative choice to meal boluses and energetic self-management of diabetes. Management-IQ expertise won’t be able to foretell sensor glucose values and regulate insulin dosing if a person’s CGM is just not working correctly or is unable to speak with their pump. Customers needs to be instructed to all the time take note of their signs and blood glucose ranges and deal with accordingly. Please go to tandemdiabetes.com/tslimX2-use for extra data.
Essential Security Data: RX ONLY. The t:slim X2 pump and Management-IQ expertise are meant for single affected person use. The t:slim X2 pump and Management-IQ expertise 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 expertise 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 linked gadgets, together with automated insulin dosing software program, to obtain, execute, and make sure instructions from these gadgets. The t:slim X2 pump is indicated to be used in people six years of age and better. Management-IQ expertise: Management-IQ expertise is meant to be used with a appropriate built-in steady glucose monitor (iCGM, bought individually) and ACE pump to robotically enhance, lower, and droop supply of basal insulin primarily based on iCGM readings and predicted glucose values. It might additionally ship correction boluses when the glucose worth is predicted to exceed a predefined threshold. Management-IQ expertise is meant for the administration of Kind 1 diabetes mellitus in individuals six years of age and better.
WARNING: Management-IQ expertise shouldn’t be utilized by anybody below the age of six years previous. 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 expertise is just not indicated to be used in pregnant ladies, individuals on dialysis, or critically unwell sufferers. Don’t use Management-IQ expertise if utilizing hydroxyurea. Customers of the t:slim X2 pump and Management-IQ expertise should: use the insulin pump, CGM, and all different system elements in accordance with their respective directions to be used; take a look at blood glucose ranges as really helpful by their healthcare supplier; display enough carb-counting expertise; preserve adequate diabetes self-care expertise; see healthcare supplier(s) often; and have enough imaginative and prescient and/or listening to to acknowledge all capabilities 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 necessary security data.
© 2021 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, t:slim X2, Management-IQ, and t:join are both registered emblems or emblems of Tandem Diabetes Care, Inc. in america and/or different international locations. Dexcom and Dexcom G6 are both registered emblems or emblems of Dexcom, Inc. in america and/or different international locations. All third-party marks are the property of their respective house owners.
1 If glucose alerts and CGM readings don’t match signs or expectations, use a blood glucose meter to make diabetes remedy choices.
2 Dexcom G6 CGM bought individually.
3 The Dexcom G6 CGM transmitter can solely be paired with one medical gadget (both a Dexcom receiver or t:slim X2 pump) and one shopper gadget (cellphone or pill) on the similar time.