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Sigi Patch Pump (Tandem / AMF Medical)

Tandem Diabetes Care (originally AMF Medical)

A rechargeable, semi-reusable tubeless patch pump using pre-filled insulin cartridges, acquired by Tandem and intended to run a Control-IQ-class automated insulin delivery algorithm. It holds FDA Breakthrough Device designation but is not yet commercially launched; as of 2026 Tandem is folding its miniaturization technology into a next-generation Mobi/"Mobi Tubeless" platform aimed at a fully closed-loop system.

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 a targeted ~2027 US launch 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 as a hybrid closed loop: automates basal and correction boluses but still requires meal announcements. A fully closed-loop algorithm is only entering pivotal trials.

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; no launch date, with FDA filing for the fully closed-loop generation targeted for 2027.

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

The Sigi Patch Pump is an automated insulin delivery (AID) system in development: a tubeless patch pump worn on the body, paired with a continuous glucose monitor (CGM) and a control algorithm. It began at Swiss startup AMF Medical (founded 2014) and was acquired by Tandem Diabetes Care, which completed the purchase in January 2023 for roughly $200 million plus milestone payments.12

Components. Unlike most patch pumps, where the whole unit is thrown away, Sigi is designed to be semi-reusable and rechargeable: a durable, rechargeable pump body snaps onto a disposable skin pad, and insulin comes in standard pre-filled, swappable cartridges holding about 160 units.34 It is built as an "Alternate Controller Enabled" pump, meaning it can receive and execute dosing commands from a Bluetooth CGM and a smartphone or dedicated controller — the architecture needed to run Tandem's Control-IQ-class automation directly.3

How the automation works. Sigi has no pivotal trial of its own yet, so its expected performance is anchored to the Control-IQ algorithm it is intended to run. 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.5 A separate trial in children aged 6–13 found a similar 11-point time-in-range improvement (53% to 67%).6

Automation level and exercise. 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.57 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 2026.8

Ages, indications, and access. Sigi is prescription-only, for people with diabetes on insulin therapy.3 No commercial version exists yet in any region. It holds FDA Breakthrough Device designation (granted 30 November 2021), which prioritizes its regulatory review but is not an approval.3

What's coming. The most important honest caveat: as of 2026, Tandem has not committed to launching a standalone product branded "Sigi." Instead, the company says it is folding Sigi's miniaturization technology into a next-generation, smaller Tandem Mobi and a "Mobi Tubeless" option that converts the Mobi into a tubeless patch, with a 510(k) filing and a launch planned around 2026 (pending FDA clearance).8 In parallel, Tandem is targeting integration of a dual glucose-ketone sensor and a fully closed-loop algorithm, with the pivotal trial for that algorithm planned for late 2026 and an FDA filing in 2027.8 So the durable, rechargeable patch concept lives on — but likely under the Mobi name, on a longer timeline than the standalone Sigi originally implied.

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. 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 ↩4

  4. 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 ↩

  5. 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076915/ ↩ ↩2

  6. 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC7920146/ ↩

  7. 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/ ↩

  8. Tandem Diabetes Care. Q4 2025 earnings call: next-generation Mobi with Sigi miniaturization, Mobi Tubeless 510(k) filing and 2026 launch plan, dual glucose-ketone sensor integration, fully closed-loop algorithm pivotal trial in late 2026 supporting FDA filing in 2027. Tandem Diabetes Care (TNDM) earnings transcript (2026). https://www.alphaspread.com/security/nasdaq/tndm/investor-relations/earnings-call/q4-2025 ↩ ↩2 ↩3

Coming soon

ETA · Not commercially available anywhere; Mobi Tubeless launch planned around 2026 (pending FDA clearance); fully closed-loop FDA filing targeted 2027

  • →Sigi miniaturization technology folded into a next-generation smaller Tandem Mobi and a Mobi Tubeless option; 510(k) filing and launch planned · around 2026
  • →Integration of a dual glucose-ketone sensor
  • →Fully closed-loop (unannounced-meal) algorithm pivotal trial · late 2026
  • →FDA filing for the fully closed-loop generation · 2027

Sources

  1. [1]Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes (NCT05973422) · regulatory · 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 (Sigi patch pump pipeline; planned Control-IQ AID integration, ~2027 target) · manufacturer · 2025-01-01
  4. [4]Tandem inks $216M deal for AMF Medical and its rechargeable insulin patch pump · news · 2022-01-01