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Diabeloop DBLG1

Diabeloop

A CE-marked, handset-based hybrid closed-loop that runs a self-learning algorithm pairing a Dexcom CGM with compatible pumps. Strong randomized and large real-world evidence in adults; EU-only and not FDA-cleared, with a smartphone successor (DBLG2) arriving.

Available nowStrong evidencehybrid-closed-looptubedphone-controlOfficial site ↗

The scorecard

Time in range77

Achieved median 72.1% TIR (70-180) in a 3,706-person real-world adult T1D cohort (IQR 65-79), confirmed at 72.2% in a 62-patient cohort; ~72% calibrates to 77, below the 780G 76%/80 anchor.[1]

Hypo protection80

Achieved median time <70 mg/dL of just 0.9% (and <54 mg/dL of 0.1%) in the 3,706-user German T1D cohort, excellent hypoglycemia protection in the ~1.0% / ~80 band.[1]

Automation level62

Auto-corrects and adjusts every 5 minutes from only four setup inputs, but meals must be declared (carb amount) — DBLG1 has no unannounced-meal mode.

Average glucose76

Achieved median GMI 7.0% in the 3,706-user German T1D cohort (HbA1c 6.95% / GMI 7.02% in the Spanish cohort), tracking a few points below the 72.1% TIR score.[1]

Low variability74

Achieved CV 29.6% (well under the 36% target) in the 62-patient Spanish real-world T1D cohort, indicating low glycemic variability for a good hybrid loop; the larger German cohort did not report CV.[2]

Exercise handling74

Announced physical-activity mode reduces insulin and suggests preventive carbs; trial showed no excess hypoglycemia on activity days.

Customizability70

Adjustable hyper/hypo thresholds, multiple activity profiles, and a self-learning model that personalizes ratios automatically.

Access & cost45

Available across several EU countries (e.g. France, Germany, Spain) but EU-only and not FDA-cleared; reimbursement and pump availability vary.

Freedom (form factor)54

Pairs with compact pumps including the semi-patch Kaleido; less tubing burden than a classic pump, but 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 Diabeloop DBLG1 is a hybrid closed-loop ("artificial pancreas") system: three parts working together — a Dexcom continuous glucose monitor (CGM), a compatible insulin pump, and a dedicated handset (a locked-down smartphone) that runs Diabeloop's self-learning algorithm.1 Every five minutes the algorithm reads the CGM value and decides how much insulin the pump should deliver, aiming to keep glucose in a healthy range.2 It is notable for needing only four setup inputs — body weight, total daily insulin dose, a typical meal in grams of carbohydrate, and a safety basal rate — after which the machine-learning model figures out the user's insulin ratios and sensitivity itself, and keeps refining them.3

How automated is it? DBLG1 is a hybrid loop, so it handles background (basal) insulin and automatic correction doses on its own, but the user still announces meals by entering the carbohydrate amount.23 It cannot silently absorb an unannounced meal — that fully automatic behavior is reserved for the newer DBLG2 (see below).4

Pivotal trial results. In the randomized crossover WP7 trial of 63 adults (NCT02987556), time in range (3.9–10.0 mmol/L / 70–180 mg/dL) was 68.5% on DBLG1 versus 59.4% on a sensor-augmented pump — a 9.2 percentage-point gain.2 A 6-month real-world study saw time in range rise from 53% to 69.7%, HbA1c fall from 7.9% to 7.1%, and time below 70 mg/dL drop from 2.4% to 1.3%, with no serious adverse events.5 A large German analysis of the first 3,706 users found a median time in range of 72.1%, time below 70 mg/dL of just 0.9%, time below 54 mg/dL of 0.1%, and a glucose management indicator (GMI) around 7.0%.6 A pooled analysis showed DBLG1 more than halved time spent low even in people who were highly hypoglycemia-prone at baseline.7

Exercise. When the user announces planned physical activity, DBLG1 reduces insulin and, if needed, recommends preventive carbohydrates; a trial sub-analysis found no extra hypoglycemia on activity days versus rest days.8

Ages and indications. DBLG1 is CE-marked for adults with type 1 diabetes.1 A pediatric adaptation, DBL4K, was tested in a randomized trial in children aged 6–12, where it cut time spent low to 2.04% (versus 7.06% on a sensor-augmented pump) with good control.9 The system is not FDA-cleared and is sold only in Europe (e.g. France, Germany, Spain).410

Access. DBLG1 pairs a Dexcom G6 CGM with one of several compatible pumps — the Accu-Chek Insight (Roche), Kaleido (ViCentra), Dana-i (SOOIL), and MEDISaFE — making it unusually interoperable for a commercial loop.1011

What's coming. Diabeloop's successor, DBLG2, moves the same clinically proven algorithm onto the user's own smartphone (Android/iOS), adds Dexcom G7 support, and — crucially — is the first AID where meal announcements are no longer mandatory.412 DBLG2 received CE marking under the EU Medical Device Regulation in August 2025 and FDA 510(k) clearance in January 2026, marking Diabeloop's entry into the US market.412 DBLG1 itself continues to phase toward this smartphone-based future.

References

  1. meddeviceonline / Diabeloop. Diabeloop Obtains CE Marking for its DBLG1. MedDevice Online (2018). https://www.meddeviceonline.com/doc/diabeloop-obtains-ce-marking-for-its-dblg-0001 ↩ ↩2

  2. Benhamou P-Y, Franc S, Reznik Y, et al. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit Health (2019). https://doi.org/10.1016/S2589-7500%2819%2930003-2 ↩ ↩2 ↩3

  3. Diabeloop. DBLG1 self-learning algorithm: easy to use for optimized and personalized T1D management. PR Newswire (2021). https://www.prnewswire.com/news-releases/dblg1-self-learning-algorithm-easy-to-use-for-optimized-and-personalized-t1d-management-301303809.html ↩ ↩2

  4. Diabeloop. Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App. Diabeloop press release (2026). https://www.diabeloop.com/media-press/press-releases/diabeloop-fda-510k-clearance ↩ ↩2 ↩3 ↩4

  5. Amadou C, Franc S, Benhamou P-Y, et al. Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up. Diabetes Care (2021). https://doi.org/10.2337/dc20-1809 ↩

  6. Benhamou P-Y, Adenis A, Lebbad H, et al. One-year real-world performance of the DBLG1 closed-loop system: Data from 3706 adult users with type 1 diabetes in Germany. Diabetes Obes Metab (2023). https://doi.org/10.1111/dom.15008 ↩

  7. Benhamou P-Y, Adenis A, Tourki Y, et al. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. J Diabetes Sci Technol (2022). https://doi.org/10.1177/19322968221128565 ↩

  8. Franc S, Benhamou P-Y, Borot S, et al. No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial. Diabetes Obes Metab (2021). https://doi.org/10.1111/dom.14442 ↩

  9. Kariyawasam D, Morin C, Casteels K, et al. Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6-12 years: a randomised, controlled, cross-over, non-inferiority trial. Lancet Digit Health (2022). https://doi.org/10.1016/S2589-7500%2821%2900271-5 ↩

  10. Diabeloop. Dexcom Sensors Update and DBLG1 System: What You Need to Know. Diabeloop (2025). https://www.diabeloop.com/news/health-sector/dblg1-dexcom-g7-update ↩ ↩2

  11. Diabeloop. Diabeloop and SOOIL launch DBLG1 with Dana-i Pump in Germany, Distributed by Mediq. Diabeloop (2025). https://www.diabeloop.com/news/company/diabeloop-and-sooil-launch-dblg1-with-dana-i-pump-in-germany-distributed-by-mediq ↩

  12. Diabeloop. DBLG2 from Diabeloop Becomes the First Automated Insulin Delivery (AID) Cleared by FDA and CE Mark Where Meal Announcements Are No Longer Mandatory. Diabeloop (2026). https://www.diabeloop.com/news/health-sector/dblg2-no-meal-announcements-en ↩ ↩2

What's next for this

  • →Successor DBLG2 moves the same algorithm onto the user's own smartphone (Android/iOS) and makes meal announcements no longer mandatory
  • →DBLG2 added Dexcom G7 support, received EU MDR CE marking (Aug 2025) and FDA 510(k) clearance (Jan 2026)
  • →DBLG1 continues phasing toward the smartphone-based future

Sources

  1. [1]One-year real-world performance of the DBLG1 closed-loop system: Data from 3706 adult users with type 1 diabetes in Germany · peer-reviewed · 2023-01-01
  2. [2]Efficacy, Safety, and Satisfaction with the Accu-Chek Insight with Diabeloop Closed-Loop System in Subjects with Type 1 Diabetes: A Multicenter Real-World Study · peer-reviewed · 2023-01-01
  3. [3]Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up · peer-reviewed · 2021-01-01