Tandem Diabetes Care Announces NEJM Publication of Positive Pivotal Study Outcomes with Control-IQ+ AID Technology in Type 2 Diabetes
Tandem Diabetes Care (TNDM) announced positive results from its pivotal trial of Control-IQ+ automated insulin delivery technology for type 2 diabetes, published in The New England Journal of Medicine. The 13-week study showed significant improvements in glycemic control across a diverse population of 319 participants.
Key findings include:
- A1C reduction of 0.9% in Control-IQ+ group vs 0.3% in control group
- 2.3% A1C reduction in participants with baseline A1C ≥9%
- Time in range improved by 16%, adding 3.8 more hours/day in target range
- Insulin use decreased by 8 units/day in Control-IQ+ group
The study demonstrated effectiveness across diverse demographics, with 39% of participants from minority backgrounds. The technology proved safe with no new safety concerns, and received high usability scores regardless of participants' bolusing strategy.
Tandem Diabetes Care (TNDM) ha annunciato risultati positivi dal suo studio fondamentale sulla tecnologia di somministrazione automatica di insulina Control-IQ+ per il diabete di tipo 2, pubblicato nel New England Journal of Medicine. Lo studio di 13 settimane ha mostrato significativi miglioramenti nel controllo glicemico in una popolazione diversificata di 319 partecipanti.
I risultati chiave includono:
- Riduzione dell'A1C dello 0,9% nel gruppo Control-IQ+ rispetto allo 0,3% nel gruppo di controllo
- Riduzione dell'A1C del 2,3% nei partecipanti con A1C basale ≥9%
- Il tempo in intervallo è migliorato del 16%, aggiungendo 3,8 ore/giorno in intervallo target
- Il consumo di insulina è diminuito di 8 unità/giorno nel gruppo Control-IQ+
Lo studio ha dimostrato l'efficacia attraverso diverse demografie, con il 39% dei partecipanti provenienti da background minoritari. La tecnologia si è rivelata sicura senza nuove preoccupazioni per la sicurezza e ha ricevuto punteggi elevati di usabilità indipendentemente dalla strategia di somministrazione dei partecipanti.
Tandem Diabetes Care (TNDM) anunció resultados positivos de su ensayo pivotal sobre la tecnología de entrega automática de insulina Control-IQ+ para la diabetes tipo 2, publicado en el New England Journal of Medicine. El estudio de 13 semanas mostró mejoras significativas en el control glucémico en una población diversa de 319 participantes.
Los hallazgos clave incluyen:
- Reducción del A1C del 0.9% en el grupo Control-IQ+ frente al 0.3% en el grupo de control
- Reducción del A1C del 2.3% en participantes con A1C basal ≥9%
- El tiempo en rango mejoró en un 16%, añadiendo 3.8 horas/día en el rango objetivo
- El uso de insulina disminuyó en 8 unidades/día en el grupo Control-IQ+
El estudio demostró efectividad a través de diversas demografías, con el 39% de los participantes de orígenes minoritarios. La tecnología demostró ser segura sin nuevas preocupaciones de seguridad, y recibió altas puntuaciones de usabilidad independientemente de la estrategia de bolus de los participantes.
탠덤 다이어베티스 케어 (TNDM)는 제2형 당뇨병을 위한 Control-IQ+ 자동 인슐린 전달 기술의 주요 시험에서 긍정적인 결과를 발표했습니다. 이 연구는 뉴 잉글랜드 저널 오브 메디신에 게재되었습니다. 13주 동안의 연구는 319명의 다양한 참가자들 사이에서 혈당 조절의 유의미한 개선을 보여주었습니다.
주요 발견 사항은 다음과 같습니다:
- Control-IQ+ 그룹에서 A1C가 0.9% 감소한 반면, 대조군에서는 0.3% 감소
- 기초 A1C ≥9%인 참가자에서 A1C가 2.3% 감소
- 목표 범위에서의 시간은 16% 개선되어 하루 3.8시간 더 추가됨
- Control-IQ+ 그룹에서 인슐린 사용량이 하루 8단위 감소
이 연구는 다양한 인구 통계에서 효과를 입증했으며, 참가자의 39%가 소수 민족 배경을 가지고 있었습니다. 이 기술은 새로운 안전 문제 없이 안전성을 입증하였고, 참가자의 볼루스 전략에 관계없이 높은 사용성 점수를 받았습니다.
Tandem Diabetes Care (TNDM) a annoncé des résultats positifs de son essai fondamental sur la technologie de livraison automatique d'insuline Control-IQ+ pour le diabète de type 2, publié dans le New England Journal of Medicine. L'étude de 13 semaines a montré des améliorations significatives du contrôle glycémique dans une population diversifiée de 319 participants.
Les principales conclusions comprennent:
- Réduction de l'A1C de 0,9% dans le groupe Control-IQ+ contre 0,3% dans le groupe témoin
- Réduction de l'A1C de 2,3% chez les participants avec un A1C de départ ≥9%
- Le temps dans la plage cible a augmenté de 16%, ajoutant 3,8 heures/jour dans la plage cible
- Utilisation de l'insuline réduite de 8 unités/jour dans le groupe Control-IQ+
L'étude a démontré son efficacité à travers diverses démographies, avec 39% des participants issus de milieux minoritaires. La technologie s'est révélée sûre sans nouvelles préoccupations en matière de sécurité et a reçu des scores d'utilisabilité élevés, quelle que soit la stratégie de bolus des participants.
Tandem Diabetes Care (TNDM) hat positive Ergebnisse aus seiner entscheidenden Studie zur automatisierten Insulinabgabe-Technologie Control-IQ+ für Typ-2-Diabetes bekannt gegeben, die im New England Journal of Medicine veröffentlicht wurde. Die 13-wöchige Studie zeigte signifikante Verbesserungen der glykämischen Kontrolle in einer vielfältigen Population von 319 Teilnehmern.
Wichtige Ergebnisse umfassen:
- Reduktion des A1C um 0,9% in der Control-IQ+-Gruppe im Vergleich zu 0,3% in der Kontrollgruppe
- 2,3% A1C-Reduktion bei Teilnehmern mit einem Ausgangs-A1C ≥9%
- Die Zeit im Zielbereich verbesserte sich um 16%, was 3,8 zusätzliche Stunden pro Tag im Zielbereich hinzufügt
- Der Insulinverbrauch sank um 8 Einheiten/Tag in der Control-IQ+-Gruppe
Die Studie zeigte die Wirksamkeit über verschiedene demografische Gruppen hinweg, wobei 39% der Teilnehmer aus Minderheiten stammen. Die Technologie erwies sich als sicher, ohne neue Sicherheitsbedenken, und erhielt hohe Benutzerfreundlichkeitsbewertungen, unabhängig von der Bolus-Strategie der Teilnehmer.
- Significant A1C reduction of 0.9% in Control-IQ+ group vs 0.3% in control group
- Substantial improvement in time in range (+16%, 3.8 more hours/day)
- Reduced insulin usage by 8 units/day compared to control group
- Strong efficacy across diverse population and different baseline characteristics
- High safety profile with no new safety concerns
- None.
Insights
Tandem Diabetes Care's positive Control-IQ+ study results represent a significant market expansion opportunity that could substantially impact the company's growth trajectory. The publication in NEJM - medical publishing's gold standard - validates the technology's effectiveness in treating Type 2 diabetes, a market approximately 10-15 times larger than Type 1 diabetes where Tandem has historically focused.
What makes these results particularly compelling is the 0.9% reduction in A1C compared to 0.3% in the control group, with even more dramatic improvements (2.3% reduction) in poorly controlled patients. This level of improvement is clinically meaningful and positions Control-IQ+ as a potentially transformative therapy option.
The compatibility with GLP-1 receptor agonists (like Ozempic) and SGLT-2 inhibitors is strategically crucial, as these medication classes represent the fastest-growing segments of diabetes care. This compatibility ensures Tandem's technology remains relevant amid changing treatment paradigms.
From a commercial perspective, the technology demonstrated effectiveness across diverse populations regardless of technical proficiency, suggesting minimal barriers to adoption. The reduced insulin consumption (-10 units/day difference) also represents a convenience and potential cost advantage.
This pivotal study likely positions Tandem to pursue regulatory approval for this expanded indication, potentially opening access to millions of insulin-dependent Type 2 diabetes patients who could benefit from automated insulin delivery.
The NEJM-published Control-IQ+ pivotal trial results demonstrate technical excellence that extends beyond the headline efficacy data. The most impressive technical achievement is the algorithm's adaptability across extremely diverse insulin regimens and patient characteristics.
The technology successfully navigated challenges that have historically adoption of advanced diabetes technology in Type 2 populations, including:
- Accommodating high insulin requirements (40% using >100 units/day)
- Supporting multiple bolusing methods, including simplified approaches for non-carb counters
- Maintaining effectiveness across wide BMI ranges
- Working successfully with medication combinations
- Demonstrating equal effectiveness regardless of patient numeracy/education levels
The rapid therapeutic impact - evident in the first week and sustained throughout the study - indicates robust algorithm performance without significant adaptation period. This suggests the underlying control system effectively handles the insulin resistance and variable metabolism patterns characteristic of Type 2 diabetes.
Most automated insulin delivery systems were originally designed for and tested in Type 1 diabetes populations. The successful adaptation to Type 2 physiology demonstrates Tandem's algorithm sophistication and ability to handle more complex metabolic patterns. The usability scores further validate that the technology successfully balances automation with necessary user interaction, critical for long-term adherence in chronic disease management.
– Additional data presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes –
Results published in NEJM demonstrate significant improvements in time in range and hemoglobin A1c (A1C) in people with type 2 diabetes when using Control-IQ+ technology compared to a control group (CGM group) who continued their pre-study insulin delivery method in conjunction with a continuous glucose monitoring (CGM) system. A reduction in A1C of
“This study represents the most rigorous evaluation of automated insulin delivery technology for people with type 2 diabetes ever conducted. The randomized controlled design and broad inclusion goals that did not limit participation based on A1C levels allowed us to truly determine the treatment effect of the algorithm,” said Roy W. Beck, MD, PhD, medical director of the Jaeb Center for Health Research, who coordinated the study. “These results demonstrate the substantial value of Control-IQ+ technology for people with type 2 diabetes who use insulin. It was encouraging that even people using insulin plus a GLP-1 receptor agonist drug, such as Ozempic, had substantial A1C improvement with the addition of Control-IQ+ to their treatment regimen.”
“The benefits of Control-IQ+ technology were evident across an incredibly diverse population, regardless of pre-study glycemic control or experience with diabetes technology. In fact, those with low and high numeracy scores at baseline did equally as well, suggesting that the technology was simple to use regardless of education level or their general understanding of diabetes,” said Jordan Pinsker, MD, chief medical officer at Tandem Diabetes Care. “These results underscore the potential of this technology to improve outcomes for people living with type 2 diabetes who use insulin, while helping alleviate daily therapy burden and improve quality of life.”
Study Design
The primary outcome of the 13-week study was to evaluate change in A1C with Control-IQ+ technology in adults ages 18 and older living with type 2 diabetes compared to a control group who continued their pre-study insulin regimen along with a real-time CGM system. Additional outcomes included changes in CGM-measured time in range, time in hyperglycemia, time in hypoglycemia, as well as safety events including severe hypoglycemia, diabetic ketoacidosis, and other serious adverse events.
The study included data from 319 participants across 21 clinical centers in
Importantly, participants came into the study with very varied insulin regimens.
Key Data Highlights Published by NEJM
Glycemic Control
-
Mean A1C decreased by
0.9% with Control-IQ+, from8.2% to7.3% , and by0.3% for the CGM group, from8.1% to7.7% .-
A1C decreased by
2.3% for those with the highest A1Cs in the Control-IQ+ arm at the start of the study (≥9% ).
-
A1C decreased by
-
Time in range improved by
16% with Control-IQ+, resulting in 3.8 more hours/day in range (70-180 mg/dL) than baseline, and 3.4 more hours/day in range than the control group.-
Time in range increased from
48% to64% with Control-IQ+, and51% to52% for the control group. The treatment effect with Control-IQ+ was evident in the first week and sustained for the duration of the study. - Mean glucose, time >180 mg/dL, time >250 mg/dL, and the frequency of prolonged hyperglycemic events were all lower with Control-IQ+ compared to the CGM only group.
- Treatment effects of Control-IQ+ on time in range and mean glucose were evident during both daytime and nighttime hours.
-
Time in range increased from
- Insulin use decreased by 8 units/day in the Control-IQ+ group, compared to an increase of 2 units/day in the CGM group, representing a difference of -10 units/day in favor of Control-IQ+.
- Benefits of Control-IQ+ compared to the control group were evident across a broad range of baseline characteristics including sex, race/ethnicity, body mass index, income, education, and prior experience with diabetes technology.
Safety
-
Use of Control-IQ+ proved safe, raising no new safety signals unique to type 2 diabetes users compared to previous type 1 diabetes studies.
- The frequency of hypoglycemia was low in both groups. One severe hypoglycemic event occurred in the Control-IQ+ group, which was successfully treated with oral carbohydrates.
- There were no DKA or hyperosmolar hyperglycemic syndrome events in the study.
Additional Data Highlights Presented at ATTD
Additional data related to bolus behavior and system usability/satisfaction were presented today during a symposium at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).
Meal Bolusing Methods
Different bolusing strategies were permitted throughout the study, including use of a carbohydrate calculator or entering a set amount of carbohydrate or units of insulin for small, medium, and large meals.
- All bolus strategies were very effective with Control-IQ+, resulting in similar, significant reductions in A1C across groups
- Those who used fewer user-initiated boluses, receiving a high percent of their insulin through Control-IQ+ moderated insulin delivery, also did well.
- No increase in hypoglycemia was observed between bolusing methods
Usability and Satisfaction
- Patient reported outcomes related to device satisfaction and sleep quality improved significantly with Control-IQ+ compared to the CGM group at the end of the study.
- Control-IQ+ received high usability scores regardless of bolusing strategy
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
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+, t:slim X2, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in
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. These forward-looking statements relate to, among other things, the potential of Control-IQ+ to improve outcomes for people living with type 2 diabetes who use insulin, while helping alleviate daily therapy burden and improve quality of life. These forward-looking statements are subject to numerous risks and uncertainties, including risks, for example, that the real-world clinical benefits from use of Control-IQ+ technology may not match the results reported in the study and the level of customer satisfaction from the use of our products, as well as other risks identified in our most recent Annual Report on Form 10-K, 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. Actual results could differ materially from those anticipated or projected in the forward-looking statements. 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
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.
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Source: Tandem Diabetes Care, Inc.
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