Fast Advanced Closed-Loop Therapy

NCT ID: NCT04853030

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2021-09-20

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Minimed 670G 4.0 closed loop with Faster Insulin aspart

Group Type: EXPERIMENTAL

Fiasp

Intervention Type: DRUG

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

Minimed 670G 4.0 closed loop with Standard Insulin aspart

Group Type: ACTIVE_COMPARATOR

Novorapid

Intervention Type: DRUG

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

Interventions

Fiasp

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

Intervention Type: DRUG

Novorapid

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria

UNKNOWN

Sponsor Role: collaborator

UMC Ljubljana University Children's Hospital Ljubljana

UNKNOWN

Sponsor Role: collaborator

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Graz Department of Pediatrics and Adolescent Medicine

Graz, , Austria

UMC Ljubljana University Children's Hospital Ljubljana

Ljubljana, , Slovenia

Countries

Austria; Slovenia

References

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.

Reference Type: DERIVED

PMID: 37404205 (View on PubMed)

Other Identifiers

FACT Study

Identifier Type: -

Identifier Source: org_study_id