Dual hormone closed loop in type 1 diabetes: a randomized trial

Dual hormone closed loop in type 1 diabetes: a randomized trial - DARE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53641

Enrollment

240

Registered

2022-07-29

Start date

2023-10-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes type 1

Interventions

1 group will use the dual hormone fully closed loop (Inreda Diabetic

CE marked). The other group will continue their regular treatment.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age between 18 and 75 years; * Diagnosed with type 1 diabetes mellitus at least one year ago; * HbA1c * 91 mmol/mol;

Exclusion criteria

Exclusion criteria: * Current use of non-approved hybrid closed loop device; * BMI >35 kg/m2; * eGFR

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the Time in Range (TIR; % of time spent in the 3.9-10 mmol/l target range) at 12 months, which will be compared between the intervention and the control treatment within each arm.	—

Secondary

Measure	Time frame
Secondary endpoints include cost-effectiveness, PROMs, other glycaemic outcomes, safety measures and device-related outcomes.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)