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Next-generation Mobi patch pump (Sigi technology)

Tandem Diabetes Care (originally AMF Medical)

Tandem's future miniaturized patch-pump platform, built from technology acquired with AMF Medical's rechargeable, semi-reusable Sigi concept. Tandem now presents it as a next-generation Mobi patch pump, not as a separate Sigi launch. It is distinct from the nearer-term tubeless-wear option submitted for the current Mobi and has no disclosed filing or launch date.

On the horizonEarly evidencehybrid-closed-looptubelessphone-controlOfficial site ↗

The scorecard

Time in range35

No achieved real-world Type 1 TIR exists for Sigi as an AID. Its only human cohort (NCT05973422, n=10 T1D adults) ran OPEN-LOOP in manual mode for a 15-day safety/feasibility study with no TIR endpoint and no posted results; participants were taken OFF hybrid closed-loop for the trial. Sigi's automated-insulin-delivery capability (planned Control-IQ integration) is roadmap-only, with no current regulatory or launch timeline and no clinical AID data. Scored conservatively far below the MiniMed 780G achieved anchor (~76% TIR = 80) because there is zero demonstrated closed-loop glycemic performance to credit.[1]

Hypo protection35

No achieved Type 1 time-below-70 data exist for Sigi. The first-in-human study (NCT05973422, n=10) recorded severe hypoglycemia and DKA only as adverse-event safety counts, with no TBR endpoint and no posted results, and was run open-loop without an automated hypoglycemia-mitigation algorithm engaged. Because no closed-loop hypoglycemia protection has been demonstrated, the score is set conservatively low; the calibration anchors (~1% TBR = 80) cannot be applied to a device with no measured TBR.[1]

Automation level60

Intended to inherit Tandem automation, but the final algorithm and user workflow for the Sigi-derived next-generation Mobi have not been disclosed or tested in a clinical AID cohort.[3]

Average glucose35

No achieved Type 1 average-glucose or HbA1c data have been published for Sigi. The single 10-participant feasibility study reported no glycemic outcomes and posted no results; there is no AID cohort. Scored conservatively to reflect absence of evidence rather than demonstrated performance.[1]

Low variability35

No achieved Type 1 glycemic-variability data (coefficient of variation, SD) exist for Sigi. The first-in-human study was open-loop, safety-focused, and reported no variability metrics. With no closed-loop cohort and no posted results, the score is held conservatively low.[1]

Exercise handling62

Expected to carry over Control-IQ's exercise activity mode that raises the target during activity; not yet validated in the patch form factor.

Customizability60

Projected adjustable profiles and the sleep/exercise targets of Control-IQ; final user settings for the Sigi platform are unconfirmed.

Access & cost20

Not commercially available anywhere. The tubeless Tandem Mobi that carries the current Mobi in a patch is a separate nearer-term configuration; the Sigi-derived next-generation Mobi has no announced filing or launch date.[3]

Freedom (form factor)84

A tubeless patch-pump system with a small reusable pump module — close to the freedom of a fully tubeless Pod.

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

Sigi was AMF Medical's legacy patch-pump platform, not the name Tandem now uses for a current launch candidate. The tubeless, semi-reusable design began at the Swiss startup and Tandem Diabetes Care acquired it with AMF in January 2023 for roughly $200 million plus milestone payments.12 Tandem's current roadmap instead describes a future next-generation Mobi patch pump that leverages the acquired Sigi technology.3

Components. Unlike most patch pumps, where the whole unit is thrown away, the legacy Sigi design was semi-reusable and rechargeable: a durable, rechargeable pump body snapped onto a disposable skin pad, and insulin came in standard pre-filled, swappable cartridges holding about 160 units.45 It was designed as an "Alternate Controller Enabled" pump, the architecture needed to receive dosing commands from a Bluetooth CGM and controller.4 Tandem has not disclosed which of those exact implementation details will carry into the Sigi-derived next-generation Mobi.

Automation evidence. The legacy Sigi prototype never demonstrated AID in a clinical cohort; its only registered first-in-human study ran open-loop and has no posted results.6 Control-IQ results provide context for Tandem's broader platform, not achieved performance for the Sigi-derived roadmap product. In the pivotal six-month randomized trial in people aged 14–71, Control-IQ raised time in range (70–180 mg/dL) from 61% to 71% — an ~11 percentage-point gain over a sensor-augmented pump — cut time below 70 mg/dL by about 0.88 points, and lowered HbA1c by ~0.33 points, while running in closed-loop mode ~90% of the time.7 A separate trial in children aged 6–13 found a similar 11-point time-in-range improvement (53% to 67%).8

Automation level and exercise. Current Control-IQ is a hybrid closed loop: it automates background (basal) insulin and delivers automatic correction boluses when glucose is predicted to run high, but meals must still be announced with a carbohydrate entry. It includes a sleep mode for tighter overnight targets and an exercise activity mode that raises the target during activity to reduce lows.79 Tandem has not disclosed the final algorithm or settings for the Sigi-derived product. A genuinely unannounced-meal (fully closed-loop) algorithm — where you would not count carbs — is still earlier-stage; Tandem plans to start its pivotal trial in late 2026.3

Ages, indications, and access. The legacy Sigi prototype received FDA Breakthrough Device designation on 30 November 2021, which was not an approval or a commercial indication.4 No separately branded commercial Sigi product exists in any region, and Tandem has not announced an age indication for the Sigi-derived next-generation Mobi.

What's coming. Tandem's current roadmap no longer describes a standalone product launch branded “Sigi.” It names two distinct concepts: an extended-wear site that would turn the current Mobi into a tubeless patch device, and a later, further-miniaturized next-generation Mobi patch pump that leverages the technology acquired with Sigi.3 Tandem confirmed on 6 August that it submitted a 510(k) for the current Mobi's tubeless capability during Q2 2026,10 but that filing is not a clearance and is not a filing for the Sigi-derived next-generation pump.

Tandem also lists dual glucose-ketone sensor integration and fully closed-loop algorithm work, without a current public filing or launch date on its innovations page.3 Sigi-derived design ideas therefore survive inside a future Mobi roadmap, not as a separately timed commercial product.

References

  1. Tandem Diabetes Care. AMF Medical receives FDA Breakthrough Device Designation for its Sigi Insulin Management System (company background, design, FDA designation). PR Newswire (2021). https://www.prnewswire.com/news-releases/amf-medical-receives-fda-breakthrough-device-designation-for-its-sigi-insulin-management-system-301433736.html ↩

  2. Reuter E. Tandem agrees to buy AMF, challenging Insulet for insulin pump patch market. MedTech Dive (2022). https://www.medtechdive.com/news/tandem-TNDM-acquires-AMF-Diabete-Insulin-patch-pump/638708/ ↩

  3. Tandem Diabetes Care. Product Innovations for Diabetes — current roadmap distinguishing a tubeless option for the present Mobi from a further-miniaturized next-generation Mobi patch pump that leverages acquired Sigi technology; also lists dual glucose-ketone and fully closed-loop work without launch dates. Updated 6 Aug 2026. https://www.tandemdiabetes.com/about-us/product-innovations ↩ ↩2 ↩3 ↩4

  4. AMF Medical / Tandem Diabetes Care. Sigi Insulin Management System: semi-reusable rechargeable patch pump, pre-filled cartridges, Alternate Controller Enabled, FDA Breakthrough Device Designation (30 Nov 2021). PR Newswire (2021). https://www.prnewswire.com/news-releases/amf-medical-receives-fda-breakthrough-device-designation-for-its-sigi-insulin-management-system-301433736.html ↩ ↩2 ↩3

  5. Diabetech. Tandem Sigi: next-gen tubeless, rechargeable insulin pump tech (160-unit pre-filled cartridges, rechargeable pods, on-pod Control-IQ, Dexcom/Abbott CGM compatibility). Diabetech (2024). https://www.diabetech.info/p/sigi-tandem-diabetes-tubeless-insulin-pump-in-development ↩

  6. ClinicalTrials.gov. Sigi Insulin Management System — A First-in-Human Study in Adults With Type 1 Diabetes (NCT05973422; open-loop manual-mode safety/feasibility study, estimated n=10; no posted results). https://clinicaltrials.gov/study/NCT05973422 ↩

  7. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes (Control-IQ; time in range 61%→71%, ~11-point gain; time <70 mg/dL reduced; HbA1c −0.33). N Engl J Med (2019). According to PubMed, DOI: https://doi.org/10.1056/NEJMoa1907863 ; full text: https://pmc.ncbi.nlm.nih.gov/articles/PMC7076915/ ↩ ↩2

  8. Breton MD, Kanapka LG, Beck RW, et al. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes (ages 6–13; time in range 53%→67%, ~11-point gain). N Engl J Med (2020). According to PubMed, DOI: https://doi.org/10.1056/NEJMoa2004736 ; full text: https://pmc.ncbi.nlm.nih.gov/articles/PMC7920146/ ↩

  9. Schoelwer MJ, Robic JL, Gautier T, et al. Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes (exercise/ski-camp setting; closed-loop use ~95%). Diabetes Technol Ther (2020). According to PubMed, DOI: https://doi.org/10.1089/dia.2019.0471 ; record: https://pubmed.ncbi.nlm.nih.gov/32119790/ ↩

  10. Tandem Diabetes Care. Second Quarter 2026 Financial Results (submitted 510(k) for Tandem Mobi tubeless capability). SEC Exhibit 99.1, 6 August 2026. https://www.sec.gov/Archives/edgar/data/1438133/000143813326000124/ex991-q2earningsrelease2026.htm ↩

Coming soon

ETA · Not commercially available. Tandem's current 2026 roadmap calls the Sigi-derived product a next-generation Mobi patch pump and gives no regulatory filing or launch date. The separately submitted tubeless-wear option for the current Mobi must not be treated as clearance of this future platform.

  • →Next-generation miniaturized Mobi patch pump using acquired Sigi technology · No filing or launch date disclosed
  • →Integration of a dual glucose-ketone sensor
  • →Fully closed-loop (unannounced-meal) algorithm pivotal trial

Sources

  1. [1]Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes (NCT05973422) · registry · 2024-01-01
  2. [2]Tandem Diabetes Care Completes Acquisition of Insulin Patch Pump Developer, AMF Medical · manufacturer · 2023-01-01
  3. [3]Product Innovations for Diabetes — next-generation Mobi patch pump · manufacturer · 2026-08-06 — Tandem's current roadmap distinguishes a tubeless patch option for the present Mobi from a next-generation, further-miniaturized Mobi patch pump that leverages acquired Sigi technology. It provides no launch date.
  4. [4]Tandem inks $216M deal for AMF Medical and its rechargeable insulin patch pump · news · 2022-01-01
  5. [5]Tandem Diabetes Care Announces Second Quarter 2026 Financial Results · manufacturer · 2026-08-06 — SEC Exhibit 99.1 confirms the tubeless-capability 510(k) was submitted in Q2 2026. A submission is not a clearance.