Fast Advanced Closed-Loop Therapy (FACT)

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: Type 1 Diabetes
• Intervention / Treatment: Drug: Fiasp; Drug: Novorapid

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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

• 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

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: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart
• 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