Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes

NCT04545567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-04-20

Study results available
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Summary

The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM).

Conditions

Interventions

DEVICE

RocketAP

Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal

DEVICE

USS Virginia

Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Mark D DeBoer, MD, MSc, MCR · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2021-01-18
Completion
2021-01-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04545567 on ClinicalTrials.gov