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Dual Hormone Closed Loop in Type 1 Diabetes

NCT05669547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2026-01-21

No results posted yet for this study

Summary

This study is a 12 month open-label, two-arm randomised parallel-group trial in adult type 1 diabetes patients executed in 14 centres in the Netherlands. The aim of this study is to determine the long-term clinical effectiveness of treatment with a dual-hormone (insulin and glucagon) fully closed loop system during 12 months compared to the current most used care and to the currently most advanced technological care. Secondary objectives include the assessment of cost-effectiveness, Patient Reported Outcome Measures (PROMs), other glycaemic outcomes and safety.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes type1
  • Diabetes

Interventions

DEVICE

dual hormone fully closed loop (DHFCL)

dual hormone fully closed loop consisting of an algorithm, sensors and both insulin and glucagon infusion.

Sponsors & Collaborators

  • Dutch National Health Care Institute

    collaborator OTHER

  • Inreda Diabetic B.V.

    collaborator INDUSTRY

  • UMC Utrecht

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669547 on ClinicalTrials.gov