Skip to content
type1.science

Diabeloop DBLG1

Diabeloop

What it is

A CE-marked hybrid closed-loop system for adults with T1D, using a dedicated handset, Dexcom G6 and a market-specific compatible pump. Randomized and observational evidence supports improved glucose outcomes. Pump wear and water limits depend on the pairing; DBLG2 is a separate smartphone successor.

Editorial review: .

Most recent recorded citation date: 2026-07-07. 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

Full sources ↓Full discussion ↓Report an issue →

Available nowStrong evidencehybrid-closed-looptubeddedicated-handsetOfficial 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: Median TIR 72.1% in 3,706 German adults, with mean follow-up 131 days. This observational cohort is not 3,706 people followed for a full year and does not establish superiority to another AID system.[3]
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.

Score limitations. Ratings are editorial and combine different DBLG1 cohorts and hardware pairings. Median German outcomes, Spanish mean outcomes and older randomized results are not directly comparable with another system’s population. Kaleido water protection does not apply to the handset.

Default calculation: 77 × 20 + 80 × 20 + 62 × 10 + 76 × 5 + 74 × 5 + 74 × 5 + 70 × 5 + 45 × 10 + 54 × 20 = 6760; divide by total weight 100. Unrounded weighted result: 67.6.

Time in range77

Median TIR 72.1% in 3,706 German adults, with mean follow-up 131 days. This observational cohort is not 3,706 people followed for a full year and does not establish superiority to another AID system.[3]

Hypo protection80

The German cohort reported median time below 70 mg/dL of 0.9% and below 54 mg/dL of 0.1%. Low CGM exposure does not mean severe hypoglycemia or other pump-related risks are absent.[3]

Automation level62

Automatically adjusts insulin, including corrective delivery; users still announce meals and activity. The dedicated handset must remain part of the connected system.[1]

Average glucose76

The German cohort reported median GMI 7.0%. GMI estimates glucose exposure and is not interchangeable with laboratory HbA1c; this is not a matched comparison with another AID system.[3]

Low variability74

A 62-person Spanish cohort reported mean glucose CV 29.63% in its early follow-up metrics. This small, uncontrolled cohort does not establish a universal DBLG1 variability level or superiority.[4]

Exercise handling74

A post-hoc analysis of 56 users found time below 70 mg/dL of 2.0% on activity days versus 2.2% on other days, with more preventive carbohydrate. This is not a randomized comparison against another exercise algorithm.[5]

Customizability70

The Kaleido/DBLG1 manual lists target glucose 100–130 mg/dL, separate normoglycemia, hyperglycemia and meal aggressiveness controls, and Zen mode. The rating reflects options rather than demonstrated superiority.[1]

Access & cost45

Available in European markets, with Germany documenting Insight, Kaleido and Dana-i options. Diabeloop states DBLG1 is not for sale in the US; specific pump supply and reimbursement need local confirmation.[6]

Freedom (form factor)54

With Kaleido, the compact pump can be worn on-body with tubing and is waterproof to 1.5 m for one hour. A separate DBLG1 handset remains necessary and is not waterproof; other pump pairings have their own limits.[1]

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

The system and daily work. DBLG1 uses a dedicated handset, Dexcom G6 and a compatible insulin pump. It adjusts insulin automatically, but users announce meals and physical activity. Its configurable target is 100–130 mg/dL (5.6–7.2 mmol/L), with separate insulin-aggressiveness settings and Zen mode. These controls can support individual preferences without proving the system is easier for every user.1

Wear and water depend on the pump. In Germany, Diabeloop documents DBLG1 with Accu-Chek Insight, Kaleido or Dana-i, all with Dexcom G6. These are market-specific pairings, not freely interchangeable components. The Kaleido pump has a 200-unit cartridge and can remain in water to 1.5 m for one hour; its infusion set and cartridge are used for up to three days. The DBLG1 handset is not waterproof. Short tubing and on-body wear can reduce what a person carries, but the system is not tubeless.61

Randomized evidence. WP7 randomized 68 adults; 63 completed both 12-week periods and entered the modified intention-to-treat analysis. Mean TIR was 68.5% with DBLG1 versus 59.4% with sensor-assisted pump therapy, a mean difference of 9.2 percentage points. Five severe-hypoglycemia episodes occurred during DBLG1 and three during comparator treatment, associated with hardware malfunction or human error. This older trial should not be read as a direct comparison of current AID brands.2

Real-world outcomes. The German study included 3,706 adults with at least 14 days of closed-loop use; mean follow-up was 131 days. Median TIR was 72.1%, time below 70 mg/dL 0.9%, below 54 mg/dL 0.1%, and GMI 7.0%. The title’s “one-year” does not mean every participant had a year of follow-up. Separately, a 62-person Spanish study reported mean TIR 72.23% and CV 29.63% in early follow-up, with three discontinuations and 21 people experiencing technical issues. These cohorts differ and do not establish a best brand.34

Exercise. In a post-hoc analysis of 56 WP7 users, mean time below 70 mg/dL was 2.0% on activity days and 2.2% on non-activity days. Preventive carbohydrate intake was higher on activity days (41.1 versus 21.8 g/day); time above range and glucose variability also increased. This illustrates the continuing need to plan activity and sometimes take carbohydrate, rather than proving hypoglycemia is eliminated.5

Safety update. ViCentra’s 20 April 2026 notice for Kaleido with DBLG1 reported increased hospitalizations related to prolonged hyperglycemia, mainly among newer users. It did not identify a manufacturing or product fault as the cause. The notice reinforced the response to persistent highs and Alarm 15000, and described revised alarm wording in DBLG1 version 1.18.1. Users should follow the notice and their diabetes team’s backup plan; the notice does not establish that every DBLG1 pump pairing has the same issue.8

Generations and access. DBLG1 is CE-marked for adult T1D and is not sold in the US according to Diabeloop. Dexcom G6 support continues while the sensor is available; DBLG2 is a separate smartphone successor launched with Kaleido and G7 in Germany in July 2026. A separate observational study of DBLG1 algorithm upgrades found median TIR 68.8% on v1.16 and 70.8% on v1.17 in 1,212 users over 120 days. That is a before/after version comparison, not evidence that DBLG2 outperforms DBLG1.67910

What's next for this

  • →The separate DBLG2 successor launched with smartphone control, Kaleido and Dexcom G7 in Germany in July 2026. DBLG1 handset and sensor specifications should not be transferred to that generation.

Sources

  1. [1]
  2. [2]
  3. [3]
  4. [4]
  5. [5]
  6. [6]
  7. [7]
  8. [8]
  9. [9]
  10. [10]