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Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions (AP@Home04_Phase 4)

NCT05257460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-05-09

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 ultra-rapid insulin lispro (Lyumjev) is superior to home use of closed-loop applying standard insulin lispro (Humalog).

This is a double-blind, single-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 Humalog or by an automated closed-loop system using ultra-rapid Lispro 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 include time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.

Conditions

Interventions

DEVICE

Hybrid closed-loop using ultra-rapid insulin lispro

Hybrid closed-loop using ultra-rapid insulin lispro

DEVICE

Hybrid closed-loop using standard insulin lispro

Hybrid closed-loop using standard insulin lispro

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2022-12-28
Completion
2023-03-25

Countries

  • 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 NCT05257460 on ClinicalTrials.gov