Fast Advanced Closed-Loop Therapy

NCT04853030 | Completed

• 1 other identifier: FACT Study
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time in range 70-180 mg/dl

  4 weeks for each arm of the crossover

• Time below range <70 mg/dl

  4 weeks for each arm of the crossover

• Mean glucose

  4 weeks for each arm of the crossover

Study Arms (2)

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

Interventions

Fiasp DRUG

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

Minimed 670G 4.0 closed loop with Faster Insulin aspart

Novorapid DRUG

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

Minimed 670G 4.0 closed loop with Standard Insulin aspart

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ljubljana, Faculty of Medicine: lead
• Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria: collaborator
• UMC Ljubljana University Children's Hospital Ljubljana: collaborator

Study Sites (2)

Medical University of Graz Department of Pediatrics and Adolescent Medicine

Graz, Austria

Location

UMC Ljubljana University Children's Hospital Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 37404205 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinded insulin formulation (Faster and Standard Insulin Aspart)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 21, 2021
• Study Start: April 6, 2021
• Primary Completion: September 16, 2021
• Study Completion: September 20, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-04

Locations

AU (1); SL (1)