Fast Advanced Closed-Loop Therapy

Type 1 Diabetes Clinical Trial

— FACT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853030
• Other study ID #: FACT Study
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: April 2021
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 20, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Fiasp
Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)
• Novorapid
Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid

Locations

Country	Name	City	State
Austria	Medical University of Graz Department of Pediatrics and Adolescent Medicine	Graz
Slovenia	UMC Ljubljana University Children's Hospital Ljubljana	Ljubljana

Sponsors (3)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine	Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria, UMC Ljubljana University Children's Hospital Ljubljana

Countries where clinical trial is conducted

Austria,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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