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Ypsomed mylife Loop (CamAPS FX on YpsoPump)

Ypsomed (with CamDiab and Dexcom/Abbott)

What it is

Ypsomed's commercial AID bundle: the tubed YpsoPump driven by CamDiab's adaptive CamAPS FX algorithm app, paired with a Dexcom or FreeStyle Libre sensor. From the user's perspective it is the same self-learning hybrid closed loop as CamAPS FX, sold as one integrated, phone-controlled package across the UK and EU.

Editorial review: .

Most recent recorded citation date: 2026-09-16. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

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Available nowStrong evidencehybrid-closed-looptubedphone-controlOfficial site ↗

Evidence behind this assessment

Key evidence notes. Study results, product eligibility and access answer different questions.

Who was studied?
Study populations and analysis groups vary. Product age limits alone do not describe who was studied.
Benefit or performance
Time in range: Achieved real-world TIR of 69.6% (median, IQR 61.3-77.2) across 35,714 T1D users in 19 countries (Boughton et al., Metabologia 2026) and 72.6% ± 11.5% in the 1,805-user real-world analysis, with ~70% TIR in the SMASH YpsoPump crossover trial — identical algorithm to CamAPS FX, scored at 76.[1]
Important harms and treatment burden
Read the safety discussion and original sources. A missing summary does not establish safety.
Approval and country access
Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
Follow-up and remaining uncertainty
Read the full discussion and original sources for follow-up duration and study limitations.

This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.

Editorial score: calculation and evidence

A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.

Default calculation: 76 × 20 + 78 × 20 + 75 × 10 + 56 × 20 + 75 × 5 + 74 × 5 + 74 × 5 + 80 × 5 + 58 × 10 = 7045; divide by total weight 100. Unrounded weighted result: 70.45.

Time in range76

Achieved real-world TIR of 69.6% (median, IQR 61.3-77.2) across 35,714 T1D users in 19 countries (Boughton et al., Metabologia 2026) and 72.6% ± 11.5% in the 1,805-user real-world analysis, with ~70% TIR in the SMASH YpsoPump crossover trial — identical algorithm to CamAPS FX, scored at 76.[1]

Hypo protection78

Achieved real-world time-below-70 mg/dL (<3.9 mmol/L) was 2.5% (median, IQR 1.4-3.9) in the 35,714-user cohort, 2.3% (IQR 1.3-3.6) in the 1,805-user cohort, and ~1.8% in the SMASH YpsoPump crossover trial — identical algorithm to CamAPS FX, supporting 78.[1]

Automation level75

Self-learning MPC algorithm runs ~95% in closed-loop and adapts continuously; on this YpsoPump bundle, simplified meal announcement (rough meal size) was non-inferior to full carb counting in the SMASH RCT, though meals are still announced in hybrid mode.

Average glucose75

Achieved GMI was 7.1% ± 0.5% (mean glucose 8.7 mmol/L) in the 35,714-user real-world cohort and 6.9% (mean glucose 8.4 mmol/L) in the 1,805-user cohort, aligning with CamAPS FX at 75.[1]

Low variability74

Consistent TBR (~1.8-2.5%) alongside ~70-73% TIR and GMI 6.9-7.1% across large multi-country cohorts indicates solid day-to-day stability, matching CamAPS FX at 74.[1]

Exercise handling74

Built-in Ease-off (raises target and trims insulin) and Boost modes give user-triggered exercise and illness adjustments, identical to CamAPS FX.

Customizability80

Inherits CamAPS FX's wide personal glucose target range (4.4–11.0 mmol/L by time of day) plus Ease-off/Boost modes and sensor choice (Dexcom G6/G7, FreeStyle Libre 3/3 Plus) on the YpsoPump hardware.

Access & cost58

Available across the UK, EU, and Australia with iOS and Android smartphone control and expanding sensor compatibility (Dexcom G6/G7, FreeStyle Libre 3/3 Plus); not yet commercially launched in the US.

Freedom (form factor)56

Runs on the small, light (83 g) tubed YpsoPump with full smartphone control — discreet for a tubed system, though with tubing and a 160-unit prefilled/reservoir cartridge.

AID default: 50% glucose outcomes and low-glucose protection, 40% daily experience, 10% access and cost. Freedom includes tubing, wearability, water-use limits and controller requirements. These are editorial priorities; studies and device generations differ. Check each scorecard for its evidence and limits.

The full picture

Ypsomed mylife Loop is the commercial bundle that packages the CamAPS FX algorithm onto Ypsomed's hardware. It is, from a user's day-to-day standpoint, the same self-learning hybrid closed loop as CamAPS FX — we list it as a distinct commercial system because the components, regulatory footprint and access differ from a generic "CamAPS deployment."

Components. Three pieces work as one system: the tubed mylife YpsoPump (a small 83 g pump using a 160-unit / 1.6 mL cartridge of rapid-acting analog),9 the CamAPS FX app (CamDiab's adaptive model-predictive-control algorithm, the "brain"),10 and a continuous glucose sensor — Dexcom G7 or Abbott FreeStyle Libre 3/3 Plus.11 The whole loop is driven and bolused from the user's smartphone.12

Pivotal trial outcomes. The CamAPS FX algorithm's strongest evidence is a multicenter randomized crossover trial in 74 very young children (ages 1-7). Over two 16-week periods, the closed loop raised time-in-range (70-180 mg/dL) by 8.7 percentage points versus a sensor-augmented pump, lowered mean glucose by 12.3 mg/dL and HbA1c by 0.4 points, and did not increase time in hypoglycemia; the system ran in closed-loop mode ~95% of the time.13 A trial run on this exact bundle — YpsoPump + Dexcom G6 + CamAPS FX ("mylife CamAPS FX") in youth and young adults — reported ~70% time-in-range with only ~1.8% time below 3.9 mmol/L.14

Automation level. This is a hybrid loop: meals are still announced. But that same YpsoPump bundle trial showed simplified meal announcement (rough meal sizes instead of exact carb counting) was non-inferior to full carbohydrate counting for time-in-range — a meaningful reduction in daily burden.14 The algorithm continuously re-learns the individual's insulin needs.10

Exercise modes. Two built-in activity functions: Ease-off and Boost.12

Ages & indications. The algorithm is licensed for type 1 diabetes from age 1 and up (depending on the sensor) and was the first loop algorithm specifically indicated for pregnancy (since joined in specified regions by Control-IQ+ and MiniMed 780G) — reflecting its dedicated very-young-children and pregnancy trial programs.1115 Caregivers of very young children using it reported less fear of hypoglycemia and better well-being.16

Access. It is available across the UK and much of the EU, with availability expanded to additional countries including Australia; Italy joined the rollout schedule in October 2026.11

What's coming. Sensor support keeps widening (Dexcom G7 and FreeStyle Libre 3/3 Plus are now in scope),11 and full iOS support removed the previous Android-only constraint (with the iOS CamAPS FX controller also receiving US FDA 510(k) clearance K261896 on 16 September 2026, though the YpsoPump bundle is not yet marketed in the US).117 Research continues into reducing meal burden further (the simplified-announcement work)14 and into the algorithm with faster insulins;17 the persistent ceiling, as for all hybrid loops, remains the speed of injected insulin and the need to announce meals at all.

Fully closed-loop option. CamAPS Liberty launched on 1 September 2026 in Germany, Austria and Switzerland for eligible myLoop users. This optional CamAPS FX mode removes routine meal boluses and carb counting for people with T1D aged 13+, and excludes pregnancy. The established hybrid-mode outcomes above should not be read as Liberty outcomes.18

CamAPS software safety updates. CamDiab’s notices retire affected Android app versions below 1.4(192) from 31 August 2026 for cybersecurity reasons. Pump, country, phone and sensor determine the applicable app build. Its September notices also advise checking CGM compatibility before an operating-system update. Use the manufacturer’s current notification and compatibility instructions for the exact configuration.19

What's next for this

  • →Widening sensor support (Dexcom G7 and FreeStyle Libre 3/3 Plus now in scope)
  • →Full iOS support removing the previous Android-only constraint (FDA 510(k) K261896 cleared 16 September 2026 for US iOS controller) · 2025–2026
  • →Research into reducing meal burden further (simplified announcement) and the algorithm with faster insulins
  • →Broader CamAPS Liberty fully closed-loop rollout after the September launch in Germany, Austria and Switzerland · Italy targeted 28 October 2026

Sources

  1. [1]
  2. [2]
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  7. [7]
    FDA 510(k) K261896 — CamAPS FX (iOS) interoperable automated glycemic controller clearance · Regulatory decision · 2026-09-16

    U.S. FDA. 510(k) Summary K261896 — CamAPS FX (iOS) (CamDiab Ltd.) (cleared 16 September 2026; interoperable automated glycemic controller, 21 CFR 862.1356, product code QJI; ages 2+ including pregnancy).

  8. [8]
  9. [9]

    Ypsomed/mylife Diabetescare. mylife YpsoPump insulin pump — specifications (1.6 mL/160 U cartridge; 83 g). mylife Diabetescare (2025). https://www.mylife-diabetescare.com/en/products/infusion-systems/mylife-ypsopump-insulin-pump.html

  10. [10]

    Laesser CI, et al. Simplified meal announcement study (SMASH) using hybrid closed-loop insulin delivery — describes the adaptive CamAPS FX algorithm. Diabetologia (2025). https://pubmed.ncbi.nlm.nih.gov/39560745/

  11. [11]

    Ypsomed. Ypsomed and CamDiab expand availability of mylife CamAPS FX on iOS (sensors, ages, pregnancy indication, country rollout). Ypsomed press release (10 June 2025). https://www.ypsomed.com/en/news-insights/news/press-releases/news-reader-detail-page/ypsomed-and-camdiab-expand-availability-of-mylife-camaps-fx-on-ios

  12. [12]

    Ypsomed/mylife Diabetescare. YpsoPump with mylife Loop — smartphone control, Ease-off and Boost activity functions. mylife Diabetescare (2025). https://www.mylife-diabetescare.com/en/mylife-loop.html

  13. [13]

    Ware J, et al. Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes (CamAPS FX; TIR +8.7 pp, mean glucose −12.3 mg/dL, HbA1c −0.4 pp, no rise in hypoglycemia). N Engl J Med 386:209-219 (2022). https://doi.org/10.1056/NEJMoa2111673

  14. [14]

    Laesser CI, et al. SMASH crossover trial on mylife CamAPS FX (YpsoPump, Dexcom G6): simplified meal announcement non-inferior to carb counting; TIR 69.9% vs 70.7%, time <3.9 mmol/L ~1.8%. Diabetologia 68(2):295-307 (2025). https://doi.org/10.1007/s00125-024-06319-w

  15. [15]

    Lee TTM, et al. AiDAPT: automated insulin delivery among pregnant women with type 1 diabetes (CamAPS FX) — study protocol. BMC Pregnancy Childbirth 22:282 (2022). https://doi.org/10.1186/s12884-022-04543-z

  16. [16]

    de Beaufort C, et al. Cambridge Hybrid Closed-Loop System in Very Young Children Reduces Caregivers' Fear of Hypoglycemia and Improves Well-Being. Diabetes Care 45(12):3050-3 (2022). https://doi.org/10.2337/dc22-0693

  17. [17]

    Ware J, et al. Hybrid Closed-Loop with Faster Insulin Aspart vs Standard Insulin Aspart in Very Young Children (CamAPS FX; TIR ~64-65%). Diabetes Technol Ther 25(6):431-436 (2023). https://doi.org/10.1089/dia.2023.0042

  18. [18]
  19. [19]