Type 1 Diabetes
Conditions
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.
Interventions
Sponsors
Medical University of Graz Department of Pediatrics and Adolescent Medicine, Graz, Austria
UMC Ljubljana University Children's Hospital Ljubljana
University of Ljubljana, Faculty of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Blinded insulin formulation (Faster and Standard Insulin Aspart)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time above range 180 mg/dl | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in range 70-180 mg/dl | 4 weeks for each arm of the crossover | 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 |
| Time below range <70 mg/dl | 4 weeks for each arm of the crossover | 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 |
| Mean glucose | 4 weeks for each arm of the crossover | 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 |
Countries
Austria, Slovenia
Outcome results
None listed