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Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes

NCT04878120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-05-30

Study results available
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Summary

The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.

Conditions

Interventions

DEVICE

Standard HCL System

Standard HCL system (USS Virginia)

DEVICE

HCL System with Smart Bolus Calculator

HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Chiara Fabris, PhD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2022-06-24
Completion
2022-06-28
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 NCT04878120 on ClinicalTrials.gov