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Fast Advanced Closed-Loop Therapy (FACT)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fiasp
Novorapid
Sponsored by
University of Ljubljana, Faculty of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of Graz Department of Pediatrics and Adolescent Medicine
  • UMC Ljubljana University Children's Hospital Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minimed 670G 4.0 closed loop with Faster Insulin aspart

Minimed 670G 4.0 closed loop with Standard Insulin aspart

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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 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
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

Full Information

First Posted
April 7, 2021
Last Updated
September 29, 2021
Sponsor
University of Ljubljana, Faculty of Medicine
Collaborators
Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria, UMC Ljubljana University Children's Hospital Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT04853030
Brief Title
Fast Advanced Closed-Loop Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
September 16, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ljubljana, Faculty of Medicine
Collaborators
Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria, UMC Ljubljana University Children's Hospital Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Blinded insulin formulation (Faster and Standard Insulin Aspart)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimed 670G 4.0 closed loop with Faster Insulin aspart
Arm Type
Experimental
Arm Title
Minimed 670G 4.0 closed loop with Standard Insulin aspart
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fiasp
Intervention Description
Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)
Intervention Type
Drug
Intervention Name(s)
Novorapid
Intervention Description
Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid
Primary Outcome Measure Information:
Title
Time above range 180 mg/dl
Description
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 Outcome Measure Information:
Title
Time in range 70-180 mg/dl
Description
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
Title
Time below range <70 mg/dl
Description
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
Time Frame
4 weeks for each arm of the crossover
Title
Mean glucose
Description
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
Time Frame
4 weeks for each arm of the crossover

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of Graz Department of Pediatrics and Adolescent Medicine
City
Graz
Country
Austria
Facility Name
UMC Ljubljana University Children's Hospital Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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