Benzinga | Jun 28, 2021 10:44AM EDT

Tandem Diabetes Sunday Highlighted Presentations Showing Improvements With Control-IQ Technology

Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a leading insulin delivery and diabetes technology company, today presented positive real-world data from ongoing use of the t:slim X2(tm) insulin pump with Control-IQ(r) advanced hybrid closed-loop technology, demonstrating statistically significant improvements in glycemic and patient-reported outcomes. Emphasis was placed on qualitative experiences as well as insights from diverse populations using the system. The data was presented this week during the 81st Scientific Sessions of the American Diabetes Association.

"People living with diabetes are benefiting from our Control-IQ technology across diverse populations and therapeutic backgrounds, which supports our mission to improve the lives of people living with diabetes," said John Sheridan, president and CEO of Tandem Diabetes Care. "In addition to improved glycemic control, the data presented this week demonstrated holistic improvements in people's lives including decreased diabetes burden and improved quality of life."

ADA PRESENTATION SUMMARIES

Glycemic Outcomes by Ethnicity in Adults with Type 1 Diabetes Using Control-IQ Technology: Early Results from the CLIO Study

Oral Presentation (217-OR)

Session: Insulin Delivery Systems

This presentation reported outcomes from the ongoing Control-IQ Observational (CLIO) study evaluating real-world use of the t:slim X2 insulin pump with Control-IQ technology in diverse groups of people with type 1 diabetes. At baseline, Black participants reported the highest HbA1c (8.1%) compared to participants from other ethnic cohorts. Using Control-IQ technology, Glucose Management Indicator (GMI) at 21 days reflected significant glycemic improvements across all ethnic groups with Asian participants showing the lowest GMI (6.8%) followed by Caucasian participants (7.0%). At 21 days, the median sensor time in range (TIR) of Black participants (62.7%, IQR=53.4-74.7) was significantly lower than for Caucasian participants (75.1%, IQR=70.3-81.0) while controlling for age, gender, reported exercise, annual income, and prior therapy. Baseline HbA1c was the key factor predicting sensor TIR, followed by exercise, annual income, and multiple daily injections (MDI, prior therapy). Disparities in glycemic outcomes across socioeconomic and demographic groups recorded at baseline remained after initiating an automated insulin dosing system. However, Control-IQ technology significantly improved glycemic outcomes for all ethnic groups.

Insulin Delivery Patterns Vary Across Age Groups with Use of Control-IQ Technology*

Poster Presentation (92-LB)

Category: Clinical Therapeutics/New Technology--Insulin Delivery Systems

-- Recipient of the American Diabetes Association's Diabetes Technology Interest Group 2021 Abstract Award in the Category of Clinical Therapeutics/New Technology--Insulin Delivery Systems. --

This presentation reported insulin use on the t:slim X2 pump with Control-IQ technology from the ongoing CLIO Study evaluating real-world use of the t:slim X2 insulin pump with Control-IQ technology in a large, diverse cohort with type 1 diabetes. Study sample included 1,499 participants who had uploaded at least 21 days of pump data to Tandem's t:connect(r) web application and had 75% CGM use during this time. Insulin delivery during the study was compared to standard formulas for predicting correction factor (CF = 1,800/total daily dose) and carbohydrate ratio (CR = 450/total daily dose). Results demonstrated that insulin use with the t:slim X2 pump with Control-IQ technology differed from standard prediction formulas across age groups, in that the correction factor prediction factor (CFPF) was significantly greater in children and teenagers. CFPF was lowest in children aged 6-9 and in adults aged 66 and above. Additional study is recommended, with comparison to final glycemic outcomes, to determine ideal insulin delivery settings with Automated Insulin Dosing, as examination of insulin use patterns may assist in optimizing outcomes.

* Lead author, Dr. Jordan Pinsker, is currently the Medical Director at Tandem Diabetes Care. This study was completed during Dr. Pinsker's employment at Sansum Diabetes Research Institute prior to joining the company.

"I Feel Human, I Feel Normal": A Qualitative Study of Experiences with Control-IQ Technology in Early Adopters

Poster Presentation (531-P)

Category: Psychosocial, Behavioral Medicine

This presentation reported results from qualitative analyses of semi-structured interviews conducted with adult (N=27) early adopters of Control-IQ technology to understand their experiences of initiating and continued use of this technology. Improved sleep quality, glycemic control, and sensor time in range were common themes reported by participants along with reduced burden of diabetes management. Overall, participants described valuable improvements in their quality of life, including reduced stress and decision-making around diabetes management, and increased freedom and spontaneity in daily life with continued use of Control-IQ technology.

Real-World Evaluation of Glycemic Outcomes by Prior Therapy for People with Type 1 and Type 2 Diabetes Onboarding to Control-IQ Technology

Poster Presentation (710-P)

Category: Clinical Therapeutics/New Technology--Insulin Delivery Systems

This presentation examined retrospective analysis of real-world glycemic outcomes by previous therapy between people with type 1 and type 2 diabetes over a period of six months after they onboarded to Control-IQ technology (excluding individuals who had undergone a software update from a previous Tandem system). After 180 days of starting Control-IQ technology, for prior pump users with type 1 diabetes, sensor TIR was 74% (median, IQR 65-81%) and time below <70mg/dL was 1.2% (IQR 0.6-2.1%). For prior pump users with type 2 diabetes, sensor TIR was 76% (IQR 69-82%) and time below <70mg/dL was 0.5% (IQR 0.2-1.0%). For participants transitioning from MDI, Control-IQ technology resulted in sensor TIR of 74% (IQR 64-83%) and 0.9% time below <70mg/dL (IQR 0.4-1.7%) for people with type 1 diabetes and 74% TIR (IQR 63-84%) and 0.3% time below <70mg/dL (IQR 0.1-0.6%) for people with type 2 diabetes. Using Control-IQ technology, both type 1 and type 2 diabetes participants (irrespective of prior therapy) achieved the recommended sensor TIR and time below <70mg/dL outcomes.