Fast Advanced Closed-Loop Therapy (FACT)

September 29, 2021 updated by: University of Ljubljana, Faculty of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medical University of Graz Department of Pediatrics and Adolescent Medicine
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC Ljubljana University Children's Hospital Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • The subject/carer is willing to upload pump and CGM data at regular intervals

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
  • Serious skin diseases located at places of the body corresponding with sensor insertion sites
  • Sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minimed 670G 4.0 closed loop with Faster Insulin aspart
Drug: Fiasp
Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)
Active Comparator: Minimed 670G 4.0 closed loop with Standard Insulin aspart
Drug: Novorapid
Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks for each arm of the crossover

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range 70-180 mg/dl
Time Frame: 4 weeks for each arm of the crossover
CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in time in range 70 to 180 mg/dL (3.9 to 10.0 mmol/L
4 weeks for each arm of the crossover
Time below range <70 mg/dl
Time Frame: 4 weeks for each arm of the crossover
CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in time below range 70 mg/dl
4 weeks for each arm of the crossover
Mean glucose
Time Frame: 4 weeks for each arm of the crossover
CGM derived indices over the study period of each treatment period ((Minimed 670G 4.0 closed loop with Faster Insulin aspart and Minimed 670G 4.0 closed loop with Standard Insulin aspart)) for 24/7 in mean glucose
4 weeks for each arm of the crossover

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ljubljana, Faculty of Medicine

Collaborators

Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria
UMC Ljubljana University Children's Hospital Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

September 16, 2021

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FACT Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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