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Advancements in automated insulin pumps: Tandem Diabetes Care’s Mobi

July 27, 2023

What’s new in automated insulin delivery systems?

On July 11, 2023, the FDA cleared Tandem Diabetes Care’s Mobi, the world’s smallest durable automatic insulin delivery (AID) system, for individuals with diabetes ages 6 and older. The Mobi joins the growing field of hybrid-loop systems that aim to simplify diabetes management for users who take insulin via multiple daily injections (MDI). (Tandem, 2023)

What’s the evidence?

Recent clinical guidelines from diabetes organizations worldwide, including the American Diabetes Association, state that insulin pump therapy may be beneficial for all individuals with type 1 diabetes (T1D), regardless of age. (ADA, 2023; ES, 2022)

Tandem Diabetes Care’s Control IQ, a proprietary algorithm that interprets glucose data to predict blood sugar levels and adjust insulin delivery, was validated in a meta-analysis of three randomized controlled trials and published in Diabetes Technology and Therapeutics. Results demonstrate the positive clinical impact of the system’s automatic bolusing on patient glucose control across a wide range of ages and demographics. The analysis showed an average increase of time in range—considered a healthy glucose level—of 2.8 hours and a reduction in HbA1c compared to the control group in people ages 2 to 72 years of age. (Breton, 2023)

How does it work?

The Tandem Mobi combines an infusion set, insulin pump, and a CGM with its mobile app and Control-IQ technology. The CGM sensor predicts glucose values 30 minutes ahead and adjusts insulin delivery every five minutes to prevent highs and lows. The system can also deliver automatic correction boluses for up to one hour to prevent hyperglycemia. (Tandem, 2023)

Tandem plans a limited release in late 2023 and anticipates that the Mobi will be fully available by early 2024. (Tandem, 2023)

What does this technology replace?

The Mobi joins other AID systems that allow users more flexibility and less conspicuous wearability options. Touted as the smallest durable insulin delivery system currently available in the U.S., the Mobi is controlled from a user’s smartphone, though insulin boluses can also be initiated by the on-pump button. The pump can be clipped onto clothing or worn with an armband or adhesive sleeve. The Mobi is waterproof, supports wireless charging, and receives automatic remote software updates. (Tandem, 2023)

What is the potential patient impact?

Use of insulin pumps in the U.S. has risen dramatically from <7,000 users in 1990 to nearly 100,000 users in 2000 and >350,000 users today. Of those individuals within the T1D Exchange, >60% use an insulin pump instead of an MDI regimen for intensive insulin therapy. (Berget, 2019) Small, convenient, and inconspicuous AID systems can improve daily life for individuals with diabetes.

Sources

(2023, July 11). Tandem Mobi, World’s Smallest Durable Insulin Delivery System, Receives FDA Clearance. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-mobi-worlds-smallest-durable-insulin-delivery-system

Beck RW, Kanapka, LG, Breton, MD, et al. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023;25(5):1-14. DOI: 10.1089/dia.2022.0558

Berget C, Messer LH, Forlenza GP. A Clinical Overview of Insulin Pump Therapy for the Management of Diabetes: Past, Present, and Future of Intensive Therapy. Diabetes Spectr. 2019 Aug;32(3):194-204. doi: 10.2337/ds18-0091. PMID: 31462873; PMCID: PMC6695255.

ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Cusi K, Das SR, Gibbons CH, Giurini JM, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Kosiborod M, Leon J, Lyons SK, Murdock L, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Sun JK, Woodward CC, Young-Hyman D, Gabbay RA, on behalf of the American Diabetes Association. Summary of Revisions: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S5-S9. doi: 10.2337/dc23-Srev. PMID: 36507641; PMCID: PMC9810459.