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Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI for Type 1 Diabetes

N/A
Waitlist Available
Led By Chiara Fabris, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day (dinner postprandial)
Awards & highlights

Study 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.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day (dinner postprandial)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day (dinner postprandial) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Low blood glucose index (LBGI)
Secondary outcome measures
CGM coefficient of variation
High blood glucose index
Percentage of time spent above 180 and 250 mg/dL
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SIExperimental Treatment1 Intervention
Use of Hybrid Closed Loop Control with Enhanced Prandial Dosing
Group II: Standard Hybrid Closed Loop Control (USS Virginia)Active Control1 Intervention
Use of Standard Hybrid Closed Loop Control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
2021
N/A
~30

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,009 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,726 Total Patients Enrolled
Chiara Fabris, PhDPrincipal Investigator - University of Virginia Center for Diabetes Technology
University of Virginia
3 Previous Clinical Trials
252 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes
Chiara Fabris, PhD 2021. "Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04878120.
~6 spots leftby Apr 2025
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