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Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions

NCT04055480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-09-02

No results posted yet for this study

Summary

The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is non-inferior to home use of closed-loop applying standard insulin aspart.

This is a double-blind, multi-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using standard rapid acting insulin analogue or by an automated closed-loop system using faster insulin aspart in random order.

Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.

Conditions

Interventions

DEVICE

Closed-loop using standard rapid-acting insulin

Closed-loop using standard rapid-acting insulin

DEVICE

Closed-loop using faster insulin aspart

Closed-loop using faster insulin aspart

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • Medical University of Graz

    collaborator OTHER

  • University of Cambridge

    lead OTHER

Principal Investigators

  • Roman Hovorka · University of Cambridge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-10
Primary Completion
2020-06-15
Completion
2020-08-30

Countries

  • Austria
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

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 NCT04055480 on ClinicalTrials.gov