Status:
COMPLETED
Fast Advanced Closed-Loop Therapy
Lead Sponsor:
University of Ljubljana, Faculty of Medicine
Collaborating Sponsors:
Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria
UMC Ljubljana University Children's Hospital Ljubljana
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
10-18 years
Phase:
NA
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 Faste...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04853030
Start Date
April 6 2021
End Date
September 20 2021
Last Update
October 1 2021
Active Locations (2)
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1
Medical University of Graz Department of Pediatrics and Adolescent Medicine
Graz, Austria
2
UMC Ljubljana University Children's Hospital Ljubljana
Ljubljana, Slovenia, 1000