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Closing the Loop in Adults With Type 1 Diabetes (CLEAR)

NCT04977908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-11-21

No results posted yet for this study

Summary

The main objective of this study is to determine whether home use of fully closed-loop glucose control applying ultra-rapid Lispro insulin is superior to standard insulin pump therapy with continuous glucose monitoring (CGM) in adults with type 1 diabetes on insulin pump therapy with sub-optimal glycaemic control (HbA1c ≥ 8.0%).

This is an open-label, 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 ultra-rapid Lispro insulin or by participants usual insulin pump therapy with continuous glucose monitoring in random order. A total of up to 30 adults (aiming for 24 completed participants) with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods. Participants who drop out of the study within the first 4 weeks of the first intervention arm will be replaced.

Participants will receive appropriate training in the safe use of the closed-loop devices. Participants will have access to the study team during the home study phase with 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 over the 8 week period. Secondary outcomes are HbA1c, time spent with glucose levels above and below target as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises severe hypoglycaemic episodes, diabetic ketoacidosis (DKA) events and other adverse and serious adverse events.

Conditions

Interventions

DEVICE

CamAPS HX

Fully automated closed-loop system (CamAPS HX) with ultra-rapid Lispro insulin

DEVICE

Standard insulin pump therapy with CGM

Participants usual insulin pump therapy with Dexcom G6 CGM

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2023-03-31
Completion
2023-05-31

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 NCT04977908 on ClinicalTrials.gov