Fast Advanced Closed-Loop Therapy

• Status: Completed
• Trial end date: 2021-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead 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
• Treatments: Insulin Aspart

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