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CamAPS FX

CamDiab (Cambridge, UK) / distributed by Ypsomed as mylife CamAPS FX

What it is

A phone-based adaptive hybrid closed-loop app with age and pregnancy eligibility varying by the chosen sensor, pump and regional label. CamAPS FX was FDA-cleared in May 2024; a US commercial system launch is not established here. In selected European myLoop markets, optional CamAPS Liberty now removes routine meal boluses for eligible users aged 13+, excluding pregnancy.

Editorial review: .

Most recent recorded citation date: 2026-09-01. 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-loopphone-controltubedOfficial 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.See the linked studies and their populations →
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) is the most representative figure; a smaller 1,805-user real-world analysis reported a higher 72.6% ± 11.5%. By age, real-world TIR spans ~62.5% (young adults 18-22y) to ~76.1% (≥65y). Weighting toward the large, broad, multi-age cohort at ~70% places CamAPS FX at 74 on the achieved-TIR scale calibrated to the MiniMed 780G anchor (~76% = 80) — genuinely below the 780G anchor, kept conservative because the dominant dataset sits at ~70% rather than the smaller cohort's ~73%.[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: 74 × 20 + 76 × 20 + 70 × 10 + 74 × 5 + 73 × 5 + 74 × 5 + 84 × 5 + 55 × 10 + 55 × 20 = 6875; divide by total weight 100. Unrounded weighted result: 68.75.

Time in range74

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) is the most representative figure; a smaller 1,805-user real-world analysis reported a higher 72.6% ± 11.5%. By age, real-world TIR spans ~62.5% (young adults 18-22y) to ~76.1% (≥65y). Weighting toward the large, broad, multi-age cohort at ~70% places CamAPS FX at 74 on the achieved-TIR scale calibrated to the MiniMed 780G anchor (~76% = 80) — genuinely below the 780G anchor, kept conservative because the dominant dataset sits at ~70% rather than the smaller cohort's ~73%.[1]

Hypo protection76

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 and 2.3% (IQR 1.3-3.6) in the 1,805-user cohort, staying <4% across every age group. A TBR of ~2.3-2.5% maps to the 76-78 band (the calibration places ~2-2.5% at 76-78, ~3% at 72-74); CamAPS FX's well-controlled hypoglycemia at scale supports 76.[1]

Automation level70

This score covers standard hybrid CamAPS FX, which requires meal input. Optional CamAPS Liberty adds fully closed-loop operation for eligible users in selected markets; it is separately listed and must not inherit the hybrid-mode outcome evidence.

Average glucose74

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. A GMI near 7.1% reflects solid but not class-leading average-glucose control, consistent with the ~70% achieved TIR; scored 74 to align with the time-in-range anchor.[1]

Low variability73

Glycemic variability is not reported as a coefficient of variation in the primary real-world dataset, but the consistent TBR (~2.5%) alongside a ~70% TIR and GMI 7.1% across a 35,714-user, all-ages cohort indicates good day-to-day stability without exceptional tightening. Scored 73, slightly below the TIR anchor to reflect the absence of a directly reported low-CV figure and the conservative read of the larger cohort.[1]

Exercise handling74

Ease-off raises the target and reduces insulin; Boost increases delivery. In7,464 users, time above range was lower during selected Ease-off periods, an observational association rather than a causal exercise benefit.[14]

Customizability84

Fully adjustable personal glucose target 4.4-11.0 mmol/L (default 5.8) by time of day, plus Boost/Ease-off and slowly-absorbed-meal options — among the most tunable commercial systems. Hardware choice widened again in June 2026 when Dexcom G7 joined Dexcom G6 and FreeStyle Libre 3 / 3 Plus as a supported sensor, on top of a choice of pumps (YpsoPump, DANA).[5]

Access & cost55

Available across UK/EU (and Australia/others) on Android and, since 2025, iOS; reimbursed in several systems. Sensor choice broadened in June 2026 — Dexcom G7 went live in Switzerland on 3 June with a rollout to 17 further countries at the end of June, subject to local approvals — which makes the system easier to fit around whichever CGM you can actually get. But it is still FDA-cleared as a hybrid controller in 2024, with US commercial launch not verified, so it remains unavailable in the US, and the score is unchanged.[5]

Freedom (form factor)55

Runs on small tubed pumps (YpsoPump, Dana) — compact and discreet for a tubed system, but not a tubeless patch.

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

CamAPS FX is a hybrid closed-loop app for type 1 diabetes that runs the adaptive "Cambridge" model-predictive-control algorithm on a smartphone, where it links a continuous glucose monitor (CGM) to an insulin pump.15 Rather than being a single sealed device, it is the algorithm and app from CamDiab that drives compatible hardware: the mylife YpsoPump (a small tubed pump) and DANA Diabecare RS / DANA-i pumps, paired with Dexcom G6, Dexcom G7 or Abbott FreeStyle Libre 3 / Libre 3 Plus sensors.1516 The algorithm recalculates and adjusts insulin every 8-12 minutes from CGM readings, and continuously "learns" the user's daily, day-to-day and around-meal insulin needs.17

New: Dexcom G7 support (June 2026). Dexcom G7 is no longer a promise — it went live in the mylife Loop combination (YpsoPump + CamAPS FX) in Switzerland on 3 June 2026, with rollout announced for the end of June 2026 across Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, New Zealand, Norway, Poland, Spain, Sweden, the UK and Australia — in each case subject to local regulatory approval, so the date you can actually switch depends on where you live.5 In practice this means you can now run the system on Dexcom G6, Dexcom G7 or FreeStyle Libre 3 / 3 Plus, which makes it likelier you can build a loop around whichever CGM your health system will fund.

What the trials show. Its evidence base is unusually strong — two New England Journal of Medicine randomized trials. In very young children aged 1-7 years (KidsAP02, NCT03784027), CamAPS FX raised time-in-range (70-180 mg/dL) by 8.7 percentage points versus a sensor-augmented pump, cut mean glucose by 12.3 mg/dL and HbA1c by 0.4 points, with no increase in hypoglycemia.18 In pregnancy (AiDAPT), it lifted time in the tight pregnancy target (63-140 mg/dL) to 68.2% versus 55.6% on standard care — an adjusted between-group difference of10.5 percentage points — and reduced hyperglycemia.19 Benefits persisted through the first 6 months postpartum (72% vs 54% time-in-range).20 Real-world data from 1,805 users mirror the trials: average time-in-range 72.6% (rising to ~82% in users over 65) and a glucose management indicator (GMI, an estimated HbA1c) of 6.9%.21

Does it hold up over years, not months? A Cambridge paper published in July 2026 followed 64 children aged 1-7 through an 18-month home extension after the trial. HbA1c fell from 7.3% at baseline to 6.8% during the trial phase and was still 6.8% at the end of the extension — the benefit held rather than drifting back, which is the question that matters once the novelty and the study-team support wear off.6 One honest caveat: that study's actual purpose was to measure parents' expectations of closed-loop over long-term home use (its primary outcome is a parental-expectancy questionnaire), and the HbA1c figures are a secondary observation from the same cohort — so read them as supporting evidence for durability, not as a fresh glycemic-outcomes trial.

How automated is it? It is a hybrid loop: it automates background (basal) insulin and adds automatic correction doses, but you still announce meals and enter carbohydrates so it can deliver a mealtime bolus.17 Encouragingly, a randomized trial (SMASH) found that simplified meal announcement — picking a meal "size" instead of counting carbs precisely — gave non-inferior time-in-range (69.9% vs 70.7%), easing one of the most tedious daily tasks.22 A smaller 6-month study in 34 adults, reported at ADA 2026, pointed in the same direction: loose meal estimation reached 65% time-in-range against 70% with precise carb counting, with no statistically significant difference between the groups.7 Treat that one lightly — it is a conference report rather than a published paper, and SMASH remains the stronger evidence — but the two together suggest the adaptive Cambridge algorithm is unusually forgiving of imprecise meal input. That is the practical middle ground between a strict hybrid loop and a fully closed one.

Exercise and customization. Two manual modes handle changing needs: Ease-off raises the glucose target and trims insulin ahead of exercise or other low-risk periods, and Boost increases insulin for illness or stubborn highs. A real-world analysis of 7,464 users found lower time above range during Ease-off use than during periods without it. The study reported no severe hypoglycemia or DKA attributed to either feature. Because users selected the modes under different glucose conditions, this is an observational safety analysis, not evidence that reducing insulin causes lower glucose.23 Users can set a personal glucose target anywhere from 4.4 to 11.0 mmol/L (default 5.8 mmol/L), adjustable by time of day — among the most tunable commercial systems.24

Ages, indications and access. CamAPS FX is licensed for people with type 1 diabetes aged 1 year and older and specifically indicated for use in pregnancy, with a wide approved range of 5-350 units/day total daily insulin.1516 It is no longer the only pregnancy-labelled AID: Control-IQ+ now has a pregnancy indication in specified regions. (Minimum approved age varies slightly by sensor.) CamAPS FX carries a CE mark and is available across the UK, EU, Australia and some other markets — historically Android-only, with an iOS/iPhone version launched in 2025.1616 It is FDA-cleared as a hybrid controller in 2024, although US commercial launch is not established here, so it is not available in the US.

What's coming. The 2025 iOS launch (rolling out country by country) and a new mylife Cloud data-sharing function are expanding reach and remote monitoring.16 The Dexcom G7 integration has now shipped and is working through the remaining countries as local approvals land,5 while further sensor integrations and additional pump partners continue to widen the choice of hardware.15 CamAPS Liberty has moved beyond study status: CamDiab says the optional fully closed-loop mode received notified-body approval under the EU Medical Device Regulation on 8 January 2026 and is designed to work without carbohydrate counting or pre-meal boluses.89 The 1 September 2026 announcement reports launch in Germany, Austria and Switzerland. Other markets remain subject to rollout. Standard hybrid CamAPS FX was FDA-cleared in 2024; this does not establish US commercial availability or a US Liberty indication.

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; its predecessor studies compared against nonautomated pump plus CGM.25

US regulatory correction. FDA K232603 cleared CamAPS FX on 23 May 2024 for T1D aged 2+ including pregnancy when the paired CGM is suitable. The clearance describes hybrid operation with manual meal boluses; it does not establish FDA authorization of Liberty or US commercial availability.12

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.26

What's next for this

  • →iOS/iPhone version rolling out country by country · 2025
  • →New mylife Cloud data-sharing function for remote monitoring
  • →Dexcom G7 rollout completing across the remaining mylife Loop countries, where local approvals allow · 2026
  • →Further sensor integrations and additional pump partners
  • →Broader CamAPS Liberty fully closed-loop rollout after September launch in Germany, Austria and Switzerland · Italy targeted 28 October 2026

Sources

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    mylife (Ypsomed) / CamDiab integrate Dexcom G7 into mylife Loop — Switzerland from 3 June 2026, 17 further countries from end of June 2026 · Science journalism · 2026-06-03

    Drug Delivery Business. mylife (Ypsomed) / CamDiab integrate Dexcom G7 into mylife Loop — live in Switzerland 3 June 2026, 17 further countries from end of June 2026, subject to local regulatory approval, 3 June 2026.

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    Vidou A, et al. Cambridge hybrid closed-loop use in very young children with type 1 diabetes — parental expectancies during long-term home use (Diabet Med, 2026) · Peer-reviewed study · 2026-07-01 — Primary outcome is the INSPIRE parental-expectancy questionnaire; the HbA1c figures quoted here are a secondary observation.

    Vidou A, et al. Cambridge hybrid closed-loop use in very young children with type 1 diabetes: parental expectancies during long-term home use. Diabet Med 2026 (published 1 July 2026). doi:10.1111/dme.70408. (n=64, ages 1-7; HbA1c 7.3% at baseline → 6.8% in the trial phase → 6.8% after an 18-month home extension. Primary outcome was the parental-expectancy questionnaire; HbA1c is secondary.)

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    Closed-loop updates from ADA 2026 (conference recap) · Open-source community — Conference recap, not a primary abstract — the ADA 2026 meal-estimation numbers are reported on this basis and are not used to move any score.

    Closed-loop updates from ADA 2026 — conference recap covering a 6-month CamAPS FX / mylife Loop study (n=34 adults) comparing loose meal estimation (65% time-in-range) with precise carb counting (70%), no statistically significant difference. Conference recap, not a primary published abstract.

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    CamAPS Liberty receives EU-MDR approval · Manufacturer · 2026-01-08 — CamDiab says the optional fully closed-loop mode received notified-body approval under the EU Medical Device Regulation. Approval is not evidence that the mode is already commercially available in every market.

    CamDiab. CamAPS Liberty receives EU-MDR approval (8 January 2026).

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    CamDiab announces CamAPS Liberty fully closed-loop mode · Manufacturer · 2026-03-10 — Describes a mode requiring neither carbohydrate counting nor pre-meal boluses and says availability is coming soon, subject to local approvals.

    CamDiab. CamAPS Liberty fully closed-loop mode announcement (10 March 2026) — no carbohydrate counting or pre-meal boluses; described as coming soon subject to local approval and availability.

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    FDA K232603 CamAPS FX hybrid-mode clearance · Regulatory decision · 2024-05-23

    FDA K232603 decision summary.

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    CamDiab. CamAPS FX — closed-loop insulin delivery system for type 1 diabetes (compatible pumps, sensors, ages, pregnancy). https://camdiab.com/

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    Ypsomed. Ypsomed and CamDiab expand availability of mylife CamAPS FX on iOS (compatible YpsoPump + Dexcom G6 and FreeStyle Libre 3/3 Plus; ages; pregnancy), 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

    Ypsomed. mylife CamAPS FX on iOS — 2025 expansion and mylife Cloud data sharing. 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

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    CamDiab / Health Innovation Network. CamAPS FX closed-loop system specifications (adaptive model predictive control; adjusts every 8-12 min; default target 5.8 mmol/L). https://healthinnovationnetwork.com/wp-content/uploads/2021/11/CamAPS_FX_-Specifications.pdf

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    Lee TTM, Collett C, Bergford S, et al. Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes (AiDAPT). N Engl J Med 2023;389:1566-1578. doi:10.1056/NEJMoa2303911. https://pubmed.ncbi.nlm.nih.gov/37796241/

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    Lee TTM, Collett C, Bergford S, et al. Automated insulin delivery during the first 6 months postpartum (AiDAPT extension). Lancet Diabetes Endocrinol 2025;13:210-220. doi:10.1016/S2213-8587(24)00340-1. https://pubmed.ncbi.nlm.nih.gov/39884300/

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    Alwan H, Wilinska ME, Ruan Y, Da Silva J, Hovorka R. Real-World Evidence Analysis of a Hybrid Closed-Loop System (mylife CamAPS FX). J Diabetes Sci Technol 2025;19:385-389. doi:10.1177/19322968231185348. https://pmc.ncbi.nlm.nih.gov/articles/PMC11873883/

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    SMASH investigators. Simplified meal announcement study (SMASH) using hybrid closed-loop insulin delivery in youth and young adults with type 1 diabetes. Diabetologia 2024. doi:10.1007/s00125-024-06319-w. https://pubmed.ncbi.nlm.nih.gov/39560745/

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    Royston C, Bergford S, Calhoun P, et al. Safety of Options to "Boost" and "Ease-Off" in the CamAPS FX Hybrid Closed-Loop System: A Real-World Analysis. Diabetes Technol Ther 2025;27:60-65. doi:10.1089/dia.2024.0298. https://pmc.ncbi.nlm.nih.gov/articles/PMC7617696/

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    Evaluating the Impact of Applying Personal Glucose Targets in a Closed-Loop System (CamAPS FX; default 5.8 mmol/L, adjustable 4.4-11.0 mmol/L). J Diabetes Sci Technol 2022. doi:10.1177/19322968221145184. https://pubmed.ncbi.nlm.nih.gov/36540007/

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