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Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery

NCT05528770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-08

Study results available
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Summary

The purpose of this study is to understand the impact of the automated priming boluses on the safety and feasibility of a new fully automated AP controller.

Conditions

Interventions

DEVICE

FCL+BPS

The automated insulin delivery system includes the Bolus Priming System, a software automatically analyzing past continuous glucose monitoring values to trigger priming insulin bolus delivery isn the suspected presence of meal like glycemic disturbances

DEVICE

FCL

The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Marc Breton

    lead OTHER

Principal Investigators

  • Sue Brown, MD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2023-01-13
Completion
2023-01-15
FDA Device
Yes

Countries

  • United States

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 NCT05528770 on ClinicalTrials.gov