Fast Advanced Closed-Loop Therapy

University of Ljubljana, Faculty of Medicine30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

FiaspDRUG

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

NovorapidDRUG

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

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Medical University of Graz Department of Pediatrics and Adolescent Medicine

Graz, Austria

UMC Ljubljana University Children's Hospital Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

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)

Time frame: 12 weeks for each arm of the crossover

Secondary Outcomes

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

Time frame: 4 weeks for each arm of the crossover

Time below range <70 mg/dl

Time frame: 4 weeks for each arm of the crossover

Mean glucose

Time frame: 4 weeks for each arm of the crossover

Data from ClinicalTrials.gov

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