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24/7 Closed-loop in Older Subjects With Type 1 Diabetes

NCT04025762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-12-06

Study results available
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Summary

The main objective of this open-label, multi-centre, randomised, crossover design study is to determine whether automated day and night closed-loop insulin delivery for 16 weeks under free living conditions is safer and more efficacious compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L (70 and 180 mg/dl) as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of human factor assessments, cardiac arrhythmias and objective sleep quality assessment will also be evaluated in this study.

Conditions

Interventions

DEVICE

Hybrid closed-loop system (CamAPS FX)

Hybrid closed-loop system

DEVICE

Sensor augmented pump therapy

Sensor augmented pump therapy

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • University Hospital Birmingham NHS Foundation Trust

    collaborator OTHER

  • Medical University of Graz

    collaborator OTHER

  • University of Cambridge

    lead OTHER

Principal Investigators

  • Roman Hovorka, PhD · University of Cambridge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-08-20
Completion
2021-08-20

Countries

  • United Kingdom

Study Locations

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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 NCT04025762 on ClinicalTrials.gov