Type 1 DiabetesFACTNCT04853030
Fast Advanced Closed-Loop Therapy
A study testing Fiasp and Novorapid in people with Type 1 Diabetes, run by University of Ljubljana, Faculty of Medicine at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Fiasp and Novorapid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Apr 2021to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site
Medical University of Graz Department of Pediatrics and Adolescent Medicine
Graz
Slovenia1 site
UMC Ljubljana University Children's Hospital Ljubljana
Ljubljana, 1000
About this study
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
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Fiasp, Novorapid
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiaspDrug
Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)
NovorapidDrug
Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid
| Study group | Role | What they receive |
|---|---|---|
| Minimed 670G 4.0 closed loop with Faster Insulin aspart | Experimental | Not described Receives: Drug: Fiasp |
| Minimed 670G 4.0 closed loop with Standard Insulin aspart | Active comparator | Not described Receives: Drug: Novorapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks for each arm of the crossover
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 4 weeks for each arm of the crossover
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start6 Apr 2021
- Primary completion16 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana, Faculty of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, UMC Ljubljana University Children's Hospital Ljubljana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853030
- Sponsor's protocol ID
- FACT Study
- Acronym
- FACT
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dovc K, Bergford S, Frohlich-Reiterer E, Zaharieva DP, Potocnik N, Muller A, Lenarcic Z, Calhoun P, Fritsch M, Sourij H, Bratina N, Kollman C, Battelino T. A Comparison of Faster Insulin Aspart with Standard Insulin Aspart Using Hybrid Automated Insulin Delivery System in Active Children and Adolescents with Type 1 Diabetes: A Randomized Double-Blind Crossover Trial. Diabetes Technol Ther. 2023 Sep;25(9):612-621. doi: 10.1089/dia.2023.0178.
PubMed 37404205
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04853030
- Acronym / sponsor ID
- FACT / FACT Study
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Ljubljana, Faculty of MedicineUniversity, hospital or other
- Collaborators
- Medical University of Graz, UMC Ljubljana University Children's Hospital Ljubljana
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimed 670G 4.0 closed loop with Faster Insulin aspart | Experimental | Drug: Fiasp |
| Minimed 670G 4.0 closed loop with Standard Insulin aspart | Active comparator | Drug: Novorapid |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiaspAdvanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp) | Drug | Minimed 670G 4.0 closed loop with Faster Insulin aspart |
| NovorapidAdvanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid | Drug | Minimed 670G 4.0 closed loop with Standard Insulin aspart |
Primary outcome
Time above range 180 mg/dl
Time frame: 12 weeks for each arm of the crossover
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)
3 secondary outcomes
Time in range 70-180 mg/dl
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Derived from this study: PubMed 37404205Dovc K, Bergford S, Frohlich-Reiterer E, Zaharieva DP, Potocnik N, Muller A, Lenarcic Z, Calhoun P, Fritsch M, Sourij H, Bratina N, Kollman C, Battelino T. A Comparison of Faster Insulin Aspart with Standard Insulin Aspart Using Hybrid Automated Insulin Delivery System in Active Children and Adolescents with Type 1 Diabetes: A Randomized Double-Blind Crossover Trial. Diabetes Technol Ther. 2023 Sep;25(9):612-621. doi: 10.1089/dia.2023.0178.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiasp and Novorapid in people with Type 1 Diabetes, run by University of Ljubljana, Faculty of Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time above range 180 mg/dl (time frame: 12 weeks for each arm of the crossover). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.