NCT04853030

Fast Advanced Closed-Loop Therapy

A Double-blind, Multinational, Multicentre, Randomised, 2-period Crossover Study to Assess the Efficacy and Safety of Advanced Closed-loop Insulin Delivery With Minimed 670 4.0 System Comparing Faster Insulin Aspart to Standard Insulin Aspart Therapy Over 4 Weeks in Active Children and Adolescents With Type 1 Diabetes - the FACT Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Ljubljana, Faculty of Medicine · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

A double-blind, multinational, multicenter, randomised, 2-period crossover study to assess the efficacy and safety of advanced closed-loop insulin delivery with Minimed 670G 4.0 system comparing Faster Insulin Aspart to Standard Insulin Aspart therapy over 4 weeks in active children and adolescents with type 1 diabetes.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Fiasp	Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)
DRUG	Novorapid	Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid

Timeline

• Start date: 2021-04-06
• Primary completion: 2021-09-16
• Completion: 2021-09-20
• First posted: 2021-04-21
• Last updated: 2021-10-01

Locations

2 sites across 2 countries: Austria, Slovenia