Clinical trial NCT04853030: Fast Advanced Closed-Loop Therapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria
name: UMC Ljubljana University Children's Hospital Ljubljana
First posted: 2021-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Time above range 180 mg/dl
timeFrame: 12 weeks for each arm of the crossover
Secondary outcomes:
measure: Time in range 70-180 mg/dl
timeFrame: 4 weeks for each arm of the crossover
measure: Time below range <70 mg/dl
timeFrame: 4 weeks for each arm of the crossover
measure: Mean glucose
timeFrame: 4 weeks for each arm of the crossover
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz Department of Pediatrics and Adolescent Medicine
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana University Children's Hospital Ljubljana
Study officials:
References: