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Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID) — HY-GRAID  

Type1 Diabetes Clinical Trial

Official title:
Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)

Clinical Trial Summary

The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a short duration of 3 days and 2 nights, or up to 60 hours.

Clinical Trial Description

The artificial pancreas platform employed under study is centered about the following four key innovations: 1) A zone model predictive control strategy that is at the same time very safe with respect to hypoglycemia, and can simultaneously and independently be tuned with respect to its response to hyperglycemia; 2) Zone control with diurnal blood-glucose target zones; 3) Models of insulin-glucose physiology and insulin on board; 4) A system for alarming and notification of impending hypoglycemia and technical malfunctions: the Health Monitoring System. These features have been evaluated in several clinical trials in adults with unannounced meals and exercise. The proposed study will evaluate enhancements to our previous system tailored for the special needs of pediatric subjects: 1) A control strategy with responses to hyperglycemia and hypoglycemia spanning wide ranges, as is typical with children; 2) The use of time-dependent zones specific for pediatric subjects; 3) The development of models for young children, capturing the greater physiologic variability, and ensuring cautious insulin delivery; 4) remote alarming and notification systems that are useful to parents. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04255381
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date October 1, 2018
Completion date December 31, 2020
View Details
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