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Tandem Diabetes Care Launches New Control-IQ+ Automated Insulin Delivery Technology in the United States

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Tandem Diabetes Care (NASDAQ: TNDM) has launched Control-IQ+ technology in the United States, an enhanced automated insulin delivery (AID) system now available for people with type 1 diabetes aged 2 years and older and adults with type 2 diabetes.

The new generation algorithm, compatible with both t:slim X2 insulin pump and Tandem Mobi System, offers expanded features including:

  • Wider weight (20-440 lbs) and total daily insulin (5-200 units) parameters
  • Enhanced extended bolus up to 8 hours with active Control-IQ+
  • New Temp Basal Rate adjustments during active Control-IQ+

The technology is now shipping in pre-loaded pumps to new customers, while eligible in-warranty Tandem customers can access the update via free remote software update. The system maintains the company's unique AutoBolus™ feature, adjusting insulin every 5 minutes based on predicted glucose values.

Tandem Diabetes Care (NASDAQ: TNDM) ha lanciato la tecnologia Control-IQ+ negli Stati Uniti, un sistema avanzato di erogazione automatica di insulina (AID) ora disponibile per le persone con diabete di tipo 1 a partire dai 2 anni e per gli adulti con diabete di tipo 2.

Il nuovo algoritmo di generazione, compatibile sia con la pompa per insulina t:slim X2 che con il Sistema Tandem Mobi, offre funzionalità ampliate tra cui:

  • Parametri di peso più ampi (20-440 lbs) e di insulina totale giornaliera (5-200 unità)
  • Bolo esteso migliorato fino a 8 ore con Control-IQ+ attivo
  • Nuove regolazioni del Tasso Basale Temporaneo durante il Control-IQ+ attivo

La tecnologia è ora in fase di spedizione in pompe pre-caricate per i nuovi clienti, mentre i clienti Tandem idonei in garanzia possono accedere all'aggiornamento tramite un aggiornamento software remoto gratuito. Il sistema mantiene la caratteristica unica AutoBolus™, che regola l'insulina ogni 5 minuti in base ai valori glicemici previsti.

Tandem Diabetes Care (NASDAQ: TNDM) ha lanzado la tecnología Control-IQ+ en los Estados Unidos, un sistema mejorado de entrega automática de insulina (AID) ahora disponible para personas con diabetes tipo 1 de 2 años en adelante y adultos con diabetes tipo 2.

El nuevo algoritmo de generación, compatible tanto con la bomba de insulina t:slim X2 como con el Sistema Tandem Mobi, ofrece funciones ampliadas que incluyen:

  • Parámetros de peso más amplios (20-440 lbs) y de insulina total diaria (5-200 unidades)
  • Bolo extendido mejorado de hasta 8 horas con Control-IQ+ activo
  • Nuevos ajustes de Tasa Basal Temporal durante el Control-IQ+ activo

La tecnología ahora se envía en bombas precargadas a nuevos clientes, mientras que los clientes de Tandem elegibles en garantía pueden acceder a la actualización a través de una actualización de software remota gratuita. El sistema mantiene la característica única AutoBolus™, ajustando la insulina cada 5 minutos en función de los valores de glucosa predichos.

탄덤 다이어베티스 케어 (NASDAQ: TNDM)는 미국에서 Control-IQ+ 기술을 출시했습니다. 이 향상된 자동 인슐린 전달(AID) 시스템은 2세 이상의 제1형 당뇨병 환자와 제2형 당뇨병 성인을 위해 제공됩니다.

새로운 세대의 알고리즘은 t:slim X2 인슐린 펌프와 탄덤 모비 시스템 모두와 호환되며, 다음과 같은 확장된 기능을 제공합니다:

  • 더 넓은 체중(20-440 lbs) 및 총 일일 인슐린(5-200 단위) 매개변수
  • Control-IQ+ 활성화 시 최대 8시간의 연장 볼루스 개선
  • Control-IQ+ 활성화 동안의 새로운 일시적 기본 요금 조정

이 기술은 새로운 고객에게 사전 로드된 펌프에서 배송되고 있으며, 보증이 유효한 탄덤 고객은 무료 원격 소프트웨어 업데이트를 통해 업데이트에 접근할 수 있습니다. 이 시스템은 예측된 포도당 값에 따라 5분마다 인슐린을 조정하는 독특한 AutoBolus™ 기능을 유지합니다.

Tandem Diabetes Care (NASDAQ: TNDM) a lancé la technologie Control-IQ+ aux États-Unis, un système amélioré de délivrance automatique d'insuline (AID) désormais disponible pour les personnes atteintes de diabète de type 1 à partir de 2 ans et pour les adultes atteints de diabète de type 2.

Le nouvel algorithme de génération, compatible à la fois avec la pompe à insuline t:slim X2 et le système Tandem Mobi, offre des fonctionnalités étendues, notamment :

  • Des paramètres de poids plus larges (20-440 lbs) et d'insuline totale quotidienne (5-200 unités)
  • Un bolus prolongé amélioré jusqu'à 8 heures avec Control-IQ+ actif
  • De nouveaux ajustements de taux basal temporaire pendant le Control-IQ+ actif

La technologie est désormais expédiée dans des pompes préchargées aux nouveaux clients, tandis que les clients Tandem éligibles sous garantie peuvent accéder à la mise à jour via une mise à jour logicielle à distance gratuite. Le système conserve la fonctionnalité unique AutoBolus™, ajustant l'insuline toutes les 5 minutes en fonction des valeurs de glucose prédites.

Tandem Diabetes Care (NASDAQ: TNDM) hat die Control-IQ+ Technologie in den Vereinigten Staaten eingeführt, ein verbessertes automatisiertes Insulinabgabesystem (AID), das jetzt für Personen mit Typ-1-Diabetes ab 2 Jahren und für Erwachsene mit Typ-2-Diabetes verfügbar ist.

Der neue Generation Algorithmus, der sowohl mit der t:slim X2 Insulinpumpe als auch mit dem Tandem Mobi System kompatibel ist, bietet erweiterte Funktionen, darunter:

  • Breitere Gewichtsparameter (20-440 lbs) und tägliche Gesamtinsulinparameter (5-200 Einheiten)
  • Verbesserter verlängerter Bolus von bis zu 8 Stunden mit aktivem Control-IQ+
  • Neue temporäre Basalrateneinstellungen während des aktiven Control-IQ+

Die Technologie wird jetzt in vorinstallierten Pumpen an neue Kunden versendet, während berechtigte Tandem-Kunden mit Garantie das Update über ein kostenloses Remote-Software-Update erhalten können. Das System behält die einzigartige AutoBolus™-Funktion des Unternehmens bei, die alle 5 Minuten Insulin basierend auf den vorhergesagten Glukosewerten anpasst.

Positive
  • Expanded market reach to include both type 1 and type 2 diabetes patients
  • Free software update for existing customers enhances customer retention
  • Technological advancement with unique AutoBolus™ feature maintains competitive advantage
  • Broader patient compatibility with expanded weight and insulin parameters
Negative
  • None.

Insights

Tandem Diabetes Care's launch of Control-IQ+ technology represents a significant expansion of their automated insulin delivery (AID) ecosystem. By extending compatibility to both their t:slim X2 pump and Tandem Mobi System while broadening patient eligibility to include children as young as 2 and adults with type 2 diabetes, Tandem has substantially increased their addressable market.

The technology's enhanced features deliver critical competitive advantages. The expanded weight (20-440 lbs) and total daily insulin parameters (5-200 units) enable treatment of a more diverse patient population. The extended bolus capability (up to 8 hours) while keeping automation active directly addresses a major clinical challenge in managing delayed glucose rises or prolonged eating scenarios. This is a notable differentiation point from competitor systems.

Tandem's strategy of offering free software updates to existing in-warranty customers strengthens user retention while maintaining their technology-as-a-service business model. The AutoBolus feature, which automatically calculates and delivers correction doses, helps overcome a common adherence challenge with missed meal boluses.

From a competitive standpoint, this launch reinforces Tandem's position against rivals like Medtronic and Insulet in the growing AID market by addressing more patient segments and offering a more personalized approach to automated insulin delivery.

The expansion of Control-IQ+ technology to younger type 1 patients and adult type 2 patients substantially broadens Tandem's market reach. This is particularly significant considering that the type 2 diabetes population is approximately 20 times larger than the type 1 market in the US.

The clinical endorsement from Dr. Paul Wadwa highlighting improved sleep, fewer adverse events, and better glucose control points to potential healthcare economic benefits beyond direct sales. Better glucose management typically translates to reduced hospitalizations and long-term complications, creating value for all healthcare stakeholders.

Tandem's approach of offering flexible personalization while maintaining ease of use addresses a key adoption barrier in diabetes technology. The temporary basal rate adjustment feature while maintaining automation supports situational management during exercise, stress, or illness – addressing real-world usage scenarios that often cause patients to abandon technology.

The no-cost software update model for existing customers demonstrates a focus on platform value rather than one-time sales, suggesting stronger customer lifetime value potential. This approach typically yields higher long-term margins and recurring revenue stability compared to hardware-only business models.

By serving a wider range of insulin requirements and use cases, Tandem has positioned itself to capture more of the expanding insulin pump and AID market, which has been experiencing significant growth as more patients transition from multiple daily injections to automated systems.

– Enhanced features extend automated insulin delivery (AID) to people ages 2 years and older with type 1 diabetes and adults with type 2 diabetes –

SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin delivery and diabetes technology company, today announced the United States commercial launch of Control-IQ+ technology, the latest generation of the company’s advanced hybrid closed-loop algorithm. Control-IQ+, compatible with both the t:slim X2 insulin pump and Tandem Mobi System, is now available for people with type 1 diabetes ages 2 years and older and adults with type 2 diabetes. Pumps pre-loaded with the updated software are now shipping to new customers, and all eligible, in-warranty Tandem customers will have access to the new features via remote software update free of charge.

Control-IQ+ automated insulin delivery technology from Tandem Diabetes Care now available for people ages 2 years and older with type 1 diabetes and adults with type 2 diabetes

Control-IQ+ automated insulin delivery technology from Tandem Diabetes Care now available for people ages 2 years and older with type 1 diabetes and adults with type 2 diabetes

“These new features allow for even greater levels of personalization and flexibility within our algorithm, while still receiving high marks for ease of use across a diverse population of users,” said John Sheridan, president and chief executive officer. “We are proud to offer this life-changing technology to millions more people living with diabetes.”

New features of the Control-IQ+ algorithm include:

  • Expanded weight (20-440 lbs.) and total daily insulin (5-200 units) parameters to accommodate a wider range of insulin requirements.
  • Enhanced extended bolus up to 8 hours with Control-IQ+ turned on, for better management for meals with delayed glucose rise or prolonged eating.
  • New Temp Basal Rate adjustments allowed when Control-IQ+ is active, to address short-term glucose needs, such as exercise, stress, or illness, while Control-IQ+ is turned on.

Control-IQ+ builds on the existing features of Tandem’s industry-leading Control-IQ algorithm, which in addition to adjusting insulin every 5 minutes based on predicted glucose values, also uses a unique AutoBolus™ feature that calculates and delivers a correction bolus to help with missed meal boluses. Control-IQ+ is also the only AID algorithm that allows users to program extended boluses of up to 8 hours while automation is active to better manage delayed glucose rises or prolonged eating.

“The benefits of AID are proven - better sleep, fewer adverse events and better glucose control - any one of these outcomes can be life changing for children living with diabetes and their families,” said Dr. Paul Wadwa, director of the pediatric clinic at the Barbara Davis Center for Diabetes and professor of pediatrics at the University of Colorado School of Medicine. “Control-IQ+ is easy to start, use, and personalize. It’s exciting to see continued advancement in the field that allows this technology to impact even more lives.”

All eligible, in-warranty Tandem users can access the software update for their pump by logging into their Tandem Source account: https://source.tandemdiabetes.com.

For more information on getting started with Tandem AID visit: https://www.tandemdiabetes.com/products/automated-insulin-delivery/control-iq

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.

Follow @TandemDiabetes on Facebook, Instagram, LinkedIn, TikTok, and X.

©2025 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ+, Control-IQ, t:slim X2, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All other third-party marks are the property of their respective owners.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things, the anticipated timing for the commercial launch of the t:slim X2 pump and the Tandem Mobi system with Control-IQ+ technology and our ability to offer the Control-IQ+ software update for current Tandem pump users. These statements are subject to numerous risks and uncertainties, including our ability to commence commercial scale manufacturing of the Tandem pump with Control-IQ+ technology and the risk that we may encounter other challenges that may delay the commercial launch of Tandem pumps with Control-IQ+ technology, as well as other risks identified in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and other documents that we file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.

Important Safety Information

RX ONLY. The t:slim X2 pump with interoperable technology (the pump) and Control-IQ+ technology (Control-IQ+) are intended for single patient use. The pump and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons 2 years of age and greater. Control-IQ+ technology: Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.

WARNING: Control-IQ+ should not be used in anyone under the age of 2 years old with Type 1 diabetes or under the age of 18 years old with Type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely.

Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

Media Contact:

858-366-6900

Media@tandemdiabetes.com

Investor Contact:

858-366-6900

IR@tandemdiabetes.com

Source: Tandem Diabetes Care, Inc.

FAQ

What are the key features of Tandem's new Control-IQ+ technology for TNDM investors?

Control-IQ+ offers expanded weight and insulin parameters, 8-hour extended bolus capability, and Temp Basal Rate adjustments, while maintaining 5-minute insulin adjustments and AutoBolus™ feature.

Who is eligible for Tandem's Control-IQ+ automated insulin delivery system?

The system is available for people with type 1 diabetes aged 2 years and older and adults with type 2 diabetes.

How can existing Tandem customers access the Control-IQ+ update?

Eligible in-warranty Tandem customers can access the software update free of charge through their Tandem Source account.

What pump systems is TNDM's Control-IQ+ compatible with?

Control-IQ+ is compatible with both the t:slim X2 insulin pump and Tandem Mobi System.
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