Fast Advanced Closed-Loop Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Fiasp
* Drug: Novorapid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimed 670G 4.0 closed loop with Faster Insulin aspart<br> | Drug: Fiasp<br>* Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)<br>|
| Active Comparator: Minimed 670G 4.0 closed loop with Standard Insulin aspart<br> | Drug: Novorapid<br>* Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 weeks for each arm of the crossover | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks for each arm of the crossover | 
| Time below range <70 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 below range 70 mg/dl | 4 weeks for each arm of the crossover | 
| Mean glucose | 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 | 4 weeks for each arm of the crossover |