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

University of Ljubljana, Faculty of Medicine2 sites in 2 countries30 target enrollmentApril 6, 2021

ConditionsType 1 Diabetes

InterventionsFiasp Novorapid

DrugsFiasp Novorapid

Overview

Phase: Not Applicable
Intervention: Fiasp
Conditions: Type 1 Diabetes
Sponsor: University of Ljubljana, Faculty of Medicine
Enrollment: 30
Locations: 2
Primary Endpoint: Time above range 180 mg/dl
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 6, 2021

End Date

September 20, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Ljubljana, Faculty of Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age between 10 and 18 years of age
•Type 1 diabetes for at least 6 months
•Insulin pump user for at least 3 months
•Total daily dose of insulin \>8 units/day
•Treated with rapid acting insulin analogue
•Subject/carer is willing to perform at least 2 finger-prick blood glucose measurements per day
•Screening HbA1c ≤ 11 % (97 mmol/mol) based on analysis from local laboratory
•Willing to wear glucose sensor
•Willing to wear closed loop system 24/7
•The subject is willing to follow study specific instructions

Exclusion Criteria

•Physical or psychological disease likely to interfere with normal conduct of the study
•Untreated coeliac disease or thyroid disease
•Current treatment with drugs known to interfere with glucose metabolism
•Participation in another interventional clinical investigation
•Treated with ultra-rapid acting insulin analogue
•Known or suspected allergy to insulin
•Carer's lack of reliable telephone facility for contact
•Subject's severe visual impairment
•Subject's severe hearing impairment
•Medically documented allergy towards the adhesive (glue) of plasters or subject is unable to tolerate tape adhesive in the area of sensor placement

Arms & Interventions

Minimed 670G 4.0 closed loop with Faster Insulin aspart

Intervention: Fiasp

Minimed 670G 4.0 closed loop with Standard Insulin aspart

Intervention: Novorapid

Outcomes

Primary Outcomes

Time above range 180 mg/dl

Time Frame: 12 weeks for each arm of the crossover

The primary outcomes is a difference in CGM-measured metrics between periods (Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart) in superiority for proportion of time \>180 mg/dL (10.0 mmol/L)