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type1.science
N/A (device / behavioral)CompletedNCT03784027

CamAPS FX hybrid closed-loop in very young children (1-7y): the KidsAP02 crossover trial

What this study tests

A randomized crossover trial in 74 children aged 1-7 with type 1 diabetes found that the CamAPS FX hybrid closed-loop system (an "artificial pancreas") increased time-in-range by 8.7 percentage points (about 2 extra hours per day) versus sensor-augmented pump therapy, lowered HbA1c and average glucose, and did not increase hypoglycemia.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2025-03-27.

Most recent recorded citation date: 2022-09-16. 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

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Children 1-7 years old (2-7 in Germany and the UK) with type 1 diabetes for at least 6 months, already using an insulin pump for at least 3 months, with screening HbA1c of 11% (97 mmol/mol) or below, willing to wear the CGM and closed-loop system around the clock. Excluded for untreated coeliac or thyroid disease, recent closed-loop use, or insulin/adhesive allergy. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
Across 74 children, time-in-target-range was 8.7 percentage points higher on closed-loop than on the sensor-augmented pump (95% CI 7.4 to 9.9; about 2 extra hours per day in range). Closed-loop also cut time spent high by 8.5 points, lowered HbA1c by 0.4 points and mean glucose by 12.3 mg/dL (about 0.7 mmol/L), while time spent low (hypoglycemia) was unchanged. The system ran in closed-loop mode 95% of the time. One severe hypoglycemia event occurred during the closed-loop period; there was no diabetic ketoacidosis.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United Kingdom, European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Between-treatment difference in the percentage of time sensor glucose was in target range (70-180 mg/dL; 3.9-10.0 mmol/L) over each 16-week period

The full picture

What was tested, and why it matters

Managing type 1 diabetes in toddlers and preschoolers is uniquely hard. Very young children eat unpredictably, can't describe how they feel, and are extremely sensitive to tiny insulin doses — so caregivers face constant glucose swings, frequent low blood sugars, and round-the-clock vigilance that disrupts the whole family's sleep and wellbeing.1 The KidsAP02 trial asked whether an "artificial pancreas" — a system that automatically adjusts insulin minute-by-minute — could do better than the usual approach in this age group.2

Who it was for

The trial enrolled children aged 1 to 7 years (2 to 7 in Germany and the UK) who had had type 1 diabetes for at least six months and were already using an insulin pump.1 A total of 74 children were randomized; their average age was 5.6 years and average starting HbA1c was 7.3%.2

How it was designed

This was an open-label, randomized, multinational crossover study run at seven centres across Austria, Germany, Luxembourg and the United Kingdom.2 Each child used both treatments, in random order, for 16 weeks each: the CamAPS FX hybrid closed-loop system (a Dana RS insulin pump and Dexcom G6 sensor linked to an Android phone running the Cambridge control algorithm) versus a sensor-augmented pump, where the family still makes all the insulin decisions.1 The main measure was the share of time glucose stayed in the target range of 70-180 mg/dL (3.9-10.0 mmol/L).2

Key results

Closed-loop control clearly came out ahead. Time-in-range was 8.7 percentage points higher with the artificial pancreas (95% CI 7.4 to 9.9) — roughly two extra hours per day in range.2 Time spent high (above 180 mg/dL) fell by 8.5 points, HbA1c dropped by 0.4 points, and average glucose fell by 12.3 mg/dL (about 0.7 mmol/L).2 Crucially, time spent low — the thing parents fear most — was no different between the two systems, so the gains did not come at the cost of more hypoglycemia.2 The system ran automatically 95% of the time, and only one severe low-glucose event occurred during the closed-loop period, with no ketoacidosis.2 A companion analysis found caregivers also reported less fear of hypoglycemia and better wellbeing on closed-loop.3

What it means and what's next

Published in the New England Journal of Medicine in 2022, KidsAP02 is among the strongest evidence that hybrid closed-loop is both effective and safe for the youngest children with type 1 diabetes.2 It helped support wider use of CamAPS FX down to age 1, and an extension phase followed families using the system long-term at home.1

Sources

  1. [1]
    Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol. · Peer-reviewed study · 2021-02-12

    Fuchs J, Allen JM, Boughton CK, et al. Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol. BMJ Open (2021).

  2. [2]
    Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes. · Peer-reviewed study · 2022-01-20

    Ware J, Allen JM, Boughton CK, et al. Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes. N Engl J Med (2022);386(3):209-219.

  3. [3]
    Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers' Fear of Hypoglycemia and Improves Their Well-Being. · Peer-reviewed study · 2022-09-16

    de Beaufort C, Schierloh U, Thankamony A, et al. Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers' Fear of Hypoglycemia and Improves Their Well-Being. Diabetes Care (2022);45(12):3050-3053.

  4. [4]