NCT03212950

Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes

Completed NA Last updated 6 November 2017

What this trial tests

NA trial testing Fast-CL in Type 1 Diabetes Mellitus in 20 participants. Completed in 1 November 2017.

Timeline

10 July 2017

Primary endpoint
1 November 2017

1 November 2017

Quick facts

Lead sponsor	University of Ljubljana, Faculty of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	10 July 2017
Primary completion	1 November 2017
Estimated completion	1 November 2017
Sites	1 location across Slovenia

Drugs / interventions tested

• Fast-CL — full drug profile →
• Regular-CL — full drug profile →

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

University of Ljubljana, Faculty of Medicine

Who can join

Adults 18 to 25, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, double-blinded (for insulin type), single centre, crossover design young adult study, on 20 subjects with type 1 diabetes (T1D), aged 18 to 25 (inclusive) years, measuring time in glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) under supervision of DreaMed Glucositter using either faster-acting insulin Aspart (Fiasp®, European Medicines Agency number EMEA/H/C/004046) or normal acting insulin Aspart.

Study duration will be about 3 weeks per subject, 5 month overall.

The objectives of this clinical investigation is:

1\. to evaluate the safety and efficacy of blood glucose control using the DreaMed Glucositter with Fiasp® in young adults with T1D during and after unannounced afternoon physical activity and unannounced meals, in a controlled in-hospital environment.

Primary endpoint is significant between-group difference (intervention Fast-CL versus control Regular-CL) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) during the unannounced afternoon exercise and unannounced standardized meals from 15:00 till 18:00 next day based on sensor glucose readings.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ultra-rapid lispro or fast-acting aspart compared to standard insulin lispro and aspart using closed-loop insulin therapy: a systematic review and meta-analysis of randomized control trials.
   Rakab MS, Rateb RM, Elsalakawi BH, Al Zoubi BM, et al · · 2025 · PMID 40547532 · DOI 10.3389/fendo.2025.1600157