Fast Advanced Closed-Loop Therapy (FACT)

University of Ljubljana, Faculty of Medicine

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Drug: Fiasp; Drug: Novorapid

Study type: Interventional

Funder types: Other

Identifiers

NCT04853030

FACT Study

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Minimed 670G 4.0 closed loop with Faster Insulin aspart

Experimental group

Treatment:

Drug: Fiasp

Minimed 670G 4.0 closed loop with Standard Insulin aspart

Active Comparator group

Treatment:

Drug: Novorapid