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Completed

NCT Number: NCT04853030

Fast Advanced Closed-Loop Therapy

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiasp

Drug

Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)

NovoRapid

Drug

Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Collaborators

  • Medical University of Graz
  • UMC Ljubljana University Children's Hospital Ljubljana

Registry information

Official study title

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

Acronym: FACT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2021
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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