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Tandem Mobi (Control-IQ+)

Tandem Diabetes Care

A miniature, phone-controlled tubed insulin pump — the smallest durable automated insulin delivery system — running the same Control-IQ+ algorithm as the t:slim X2. The hardware is new; the pivotal trial evidence comes from the shared algorithm on its predecessor pump.

Available nowStrong evidencehybrid-closed-looptubedphone-controlOfficial site ↗

The scorecard

Time in range75

Achieved ~70-71% time-in-range (70.9% at 12 months in a 473-adult real-world T1D cohort; 70.1% in the ~2,130-adult CLIO study) — sits below the 780G 76%/80 anchor; identical algorithm to t:slim X2.[1]

Hypo protection79

Achieved time-below-70 of ~1.1-1.9% in adult real-world T1D (1.9% in the 473-adult cohort; 1.1% with <54 mg/dL at 0.2% in CLIO) — strong, low-end hypoglycemia exposure.[1]

Automation level65

Hybrid loop: still requires carb counting and announced meals. Delivers automatic correction boluses (AutoBolus) but does not absorb unannounced meals.

Average glucose74

Achieved GMI/HbA1c ~6.7% at 12 months in the 473-adult real-world T1D cohort (mean glucose 158 mg/dL, ~GMI 7.0%, in CLIO adults) — tracks the ~70-71% TIR within a few points.[1]

Low variability71

Achieved ~70-71% TIR with low hypoglycemia implies controlled variability for a hybrid loop in adult T1D, but device-specific CV% is not published in the primary real-world cohorts, so scored conservatively.[2]

Exercise handling68

Manual Exercise Activity raises the target to ~140-160 mg/dL; effective but must be switched on in advance, not automatic.

Customizability70

Adjustable profiles plus Sleep and Exercise activities; the core Control-IQ correction target is fixed and not freely user-settable.

Access & cost58

Established in the US through pharmacy/DME channels. Tandem reported that an international commercial rollout began in Q2 2026, but its filing did not identify the initial countries, so non-US access remains less mature than t:slim X2 access.

Freedom (form factor)66

Built on the Tandem Mobi, the smallest tubed pump — very compact and pocketable with only a short tube, though not fully tubeless.

Glycemic criteria are scored on the levels actually achieved in large real-world Type 1 diabetes cohorts — not the headline improvement over a trial's baseline (an improvement that looks bigger when the starting population was doing poorly). Type 2 diabetes trial data is never used to score a Type 1 system; where only improvement data exists, it informs the rationale, not the score. Freedom captures form factor and wearability, so a tubeless system is rewarded for the mobility a tubed one can't match.

The full picture

The Tandem Mobi is the world's smallest durable automated insulin delivery (AID) system — a tubed pump less than half the size of Tandem's t:slim X2, small enough to fit in a coin pocket.1 It holds 200 units of insulin, recharges wirelessly by inductive charging, and is rated water-resistant (IP28, tested at 8 feet for 2 hours).2 It is fully controllable from a compatible smartphone app — there is no pump screen — though an on-pump button lets you bolus or disconnect without your phone.2

Components. Mobi is one corner of a three-part system: the pump, a Dexcom CGM (it integrates in the US with Dexcom G6, standard 10-day G7 and, since Q2 2026, G7 15 Day), and the Control-IQ+ algorithm.23 Control-IQ+ reads CGM values, predicts glucose 30 minutes ahead, and adjusts insulin every 5 minutes, adding automatic correction boluses (AutoBolus) to head off highs.2

Evidence — read this carefully. Mobi is new hardware, but it runs the same algorithm as the t:slim X2, so its trial evidence is inherited rather than Mobi-specific. In the pivotal 6-month DCLP3 randomized trial of that algorithm, time in range (70-180 mg/dL) rose from 61% to 71% (a +11 percentage-point gain vs a sensor-augmented pump), time below 70 mg/dL fell by 0.88 points, and HbA1c dropped 0.33 points — with the system in closed-loop mode ~90% of the time.4 A real-world analysis of 9,451 users found time in range climbing to ~74% and time below range steady near 1%, matching or beating the trial.5 In children, one-year real-world use lifted TIR from 51.6% to 64.4% and cut HbA1c from 7.8% to 7.1%.6 In 2025 the algorithm was also validated in type 2 diabetes: a 319-person NEJM randomized trial showed TIR rising from 48% to 64% and an adjusted HbA1c reduction of 0.6 points over 13 weeks.7

Automation level. This is a hybrid closed loop, not fully closed. You still count carbs and announce meals; the algorithm handles the background and issues auto-corrections, but it cannot yet absorb a surprise meal on its own.4 A manual Exercise Activity raises the glucose target during activity, and a Sleep Activity tightens overnight control — both switched on by the user, not detected automatically.2

Ages and indications. Mobi is FDA-cleared for people aged 2 and older.2 The underlying Control-IQ+ algorithm is cleared for type 1 diabetes and, since February 2025, for adults with type 2 diabetes who use insulin.8

Pregnancy. On 27 April 2026 the FDA cleared Control-IQ+ on both Mobi and t:slim X2 for pregnancy complicated by type 1 diabetes, and Tandem announced a corresponding European CE-mark expansion on 5 June.910 The CIRCUIT randomized trial used t:slim X2 hardware, so the evidence is for the shared algorithm and pregnancy indication rather than a Mobi-specific hardware trial.

Open FDA corrections. Three current records have different scopes and actions. Class I Z-0427-2026 covers 17,745 pumps on versions 7.6.0.1, 7.6.0.3 or 7.7.0.1: a false Malfunction 12 can stop insulin; version 7.9.0.2 or later fixes that defect specifically.11 Class I Z-1520-2025 covers 85 pumps on Control-IQ+ 7.9 whose CGM-gap interpolation can under- or over-deliver; the FDA-listed action says affected users should turn Control-IQ+ off.12 Class II Z-0232-2026 covers Mobi 7.9.0.1 and named t:slim X2 versions paired with Dexcom G7, where sensor-session timing can trigger an unexpected autobolus; users must follow Tandem's timing instructions until corrected.13 These are corrections, not a withdrawal of every Mobi, and the exact software/configuration determines which action applies.

Access. The US remains Mobi's established market, distributed through pharmacy and durable-medical-equipment channels. Tandem reported on 6 August 2026 that international commercial rollout had begun during Q2, but the filing did not name the first countries or quantify availability.3 That supports a real rollout, not blanket availability across the UK, EU, Canada and Australia.

What's coming. Mobi launched controlled only by iPhone, but in November 2025 the FDA cleared an Android version of the app, and Tandem made it available on March 4, 2026 for Google Pixel 6-10 and Samsung Galaxy S21-S25 phones — removing the iPhone-only barrier.14 Because Mobi receives wireless over-the-air software updates,1 future algorithm improvements (Tandem has signalled work toward fuller meal automation) can reach the same hardware without a new pump. Tandem also submitted a 510(k) for a tubeless Mobi wearing option in Q2 2026; that is an application under review, not a clearance or launch.3

References

  1. Tandem Diabetes Care. Tandem Mobi, World's Smallest Durable Insulin Delivery System, Receives FDA Clearance. Tandem Diabetes Care Investor News (2023). https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-mobi-worlds-smallest-durable-insulin-delivery-system/ ↩ ↩2

  2. Tandem Diabetes Care. Tandem Mobi insulin pump — product specifications (200-unit cartridge, inductive charging, IP28, app + on-pump button control, Dexcom G6/G7, AutoBolus, ages 2+). tandemdiabetes.com (2026). https://www.tandemdiabetes.com/products/insulin-pumps/tandem-mobi ↩ ↩2 ↩3 ↩4 ↩5 ↩6

  3. Tandem Diabetes Care. Second Quarter 2026 Financial Results (US G7 15 Day compatibility for Mobi; submitted tubeless-capability 510(k); international commercial rollout began). SEC Exhibit 99.1, 6 August 2026. https://www.sec.gov/Archives/edgar/data/1438133/000143813326000124/ex991-q2earningsrelease2026.htm ↩ ↩2 ↩3

  4. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes (DCLP3, NCT03563313). N Engl J Med (2019);381:1707-1717. https://pmc.ncbi.nlm.nih.gov/articles/PMC7076915/ ↩ ↩2

  5. Breton MD, Kovatchev BP. One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology. Diabetes Technol Ther (2021);23(9):601-608. https://pmc.ncbi.nlm.nih.gov/articles/PMC8501470/ ↩

  6. De Meulemeester J, Valgaerts L, Massa G, et al. Real-World Glycemic and Person-Reported Outcomes After Tandem Control-IQ Initiation in Children With Type 1 Diabetes. J Clin Endocrinol Metab (2025);110(12):3331-3341. https://pubmed.ncbi.nlm.nih.gov/40333328/ ↩

  7. Graham TE, Raghinaru D, Afreen S, et al. (Control-IQ+ type 2 pivotal trial, NCT05785832). A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes. N Engl J Med (2025). https://www.nejm.org/doi/abs/10.1056/NEJMoa2415948 ↩

  8. Cohen JK. Tandem's insulin pump tech wins FDA nod for Type 2 diabetes (Control-IQ+ cleared Feb 2025 for adults with type 2 diabetes; runs on t:slim X2 and Tandem Mobi). MedTech Dive (2025). https://www.medtechdive.com/news/tandem-diabetes-type-2-automated-insulin-delivery/741155/ ↩

  9. Tandem Diabetes Care. Control-IQ+ automated insulin delivery technology now FDA cleared for pregnancy in type 1 diabetes (27 April 2026). https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-cares-control-iq-automated-insulin-delivery ↩

  10. Tandem Diabetes Care. Automated insulin delivery systems receive CE mark for type 2 diabetes and type 1 diabetes during pregnancy (5 June 2026). https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-automated-insulin-delivery-systems-receive ↩

  11. U.S. FDA. Class I Device Recall Tandem Mobi — Z-0427-2026 (open; false Malfunction 12 can stop insulin). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=216259 ↩

  12. U.S. FDA. Class I Device Recall Tandem Mobi Control-IQ+ software 7.9 — Z-1520-2025 (open; CGM-gap interpolation can under- or over-deliver). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=212817 ↩

  13. U.S. FDA. Class II Device Recall Tandem Mobi/t:slim X2 with Dexcom G7 — Z-0232-2026 (open; unexpected autobolus risk). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=215511 ↩

  14. Drug Delivery Business News. Tandem Diabetes Care launches Mobi pump on Android phones (FDA clearance Nov 2025; available March 4, 2026 for Pixel 6-10 and Galaxy S21-S25). drugdeliverybusiness.com (2026). https://www.drugdeliverybusiness.com/tandem-diabetes-care-launches-mobi-android/ ↩

What's next for this

  • →Android version of the app (FDA cleared Nov 2025) made available for Pixel 6-10 and Galaxy S21-S25 phones · March 4, 2026
  • →Future algorithm improvements toward fuller meal automation delivered via wireless over-the-air updates to the same hardware
  • →Tubeless Mobi capability; a 510(k) was submitted in Q2 2026, which is a filing rather than an FDA clearance · FDA review pending

Sources

  1. [1]One-year real-world benefits of Tandem Control-IQ technology on glucose management and person-reported outcomes in adults with type 1 diabetes: a prospective observational cohort study · peer-reviewed · 2025-02-11
  2. [2]Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study · peer-reviewed · 2023-10-26
  3. [3]Tandem Mobi Automated Insulin Delivery System (official product page, Control-IQ+ technology) · manufacturer · 2024-02-13
  4. [4]Tandem Diabetes Care Announces Second Quarter 2026 Financial Results · manufacturer · 2026-08-06 — SEC Exhibit 99.1 reports US G7 15 Day compatibility for Mobi, a submitted 510(k) for tubeless capability, and the start of international commercial rollout. It does not identify the first non-US countries.
  5. [5]FDA Class I recall Z-0427-2026 — Tandem Mobi Malfunction 12 · regulatory · 2025-11-05 — Open correction for 17,745 pumps on software 7.6.0.1, 7.6.0.3 or 7.7.0.1; false Malfunction 12 can stop insulin. Update 7.9.0.2 or later fixes this specific defect, not every other Mobi correction.
  6. [6]FDA Class I recall Z-1520-2025 — Mobi Control-IQ+ 7.9 interpolation · regulatory · 2025-04-11 — Open correction for 85 units; a CGM-gap interpolation defect can under- or over-deliver insulin. The FDA-listed action says affected users should turn off Control-IQ+.
  7. [7]FDA Class II recall Z-0232-2026 — Mobi/t:slim X2 with Dexcom G7 · regulatory · 2025-10-23 — Open correction covering Mobi 7.9.0.1 and named t:slim X2 versions; sensor session timing can trigger an unexpected autobolus.
  8. [8]Tandem Control-IQ+ receives FDA clearance for pregnancy in type 1 diabetes · manufacturer · 2026-04-27
  9. [9]Tandem AID systems receive European pregnancy indication · manufacturer · 2026-06-05