NCT04853030CompletedNot Applicable
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 enrollmentStarted: April 6, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Time above range 180 mg/dl
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Blinded insulin formulation (Faster and Standard Insulin Aspart)
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Minimed 670G 4.0 closed loop with Faster Insulin aspart
Experimental
Intervention: Fiasp (Drug)
Minimed 670G 4.0 closed loop with Standard Insulin aspart
Active Comparator
Intervention: Novorapid (Drug)
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)
Secondary Outcomes
- Time in range 70-180 mg/dl(4 weeks for each arm of the crossover)
- Time below range <70 mg/dl(4 weeks for each arm of the crossover)
- Mean glucose(4 weeks for each arm of the crossover)
Investigators
Study Sites (2)
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