Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 6, 2024

Primary Completion Date

September 21, 2025

Study Completion Date

October 21, 2025

Conditions
Type 1 Diabetes (T1D)
Interventions
DRUG

Ultra Rapid Lispro (URLi)

"Dosage Form:~Subcutaneous insulin infusion~Dosage:~Based on individual carbohydrate counting, adjusted using the MiniMed 780G hybrid closed-loop system.~Frequency:~Administered at mealtime (premeal) during one phase and immediately after meals (postmeal) during the other phase.~Duration:~Each intervention phase lasts up to 4 weeks.~Arm or Group/Intervention Cross-Reference:~Both interventions (mealtime and postmeal dosing) are applied to the single arm of the study."

DEVICE

Insulin pump with continuous glucose monitoring (CGM)

"The insulin pump with continuous glucose monitoring (CGM) system is used by patients with Type 1 Diabetes Mellitus (T1DM) as part of their regular treatment regimen. This system combines an insulin pump with real-time glucose monitoring, adjusting basal insulin delivery every 5 minutes based on continuous glucose data. In this study, participants are already using the system before the trial begins. The research does not examine the effect of the CGM itself but rather focuses on the timing of insulin bolus delivery (mealtime vs. postmeal) using their existing treatment system.~Frequency:~The system delivers basal insulin continuously and requires the patient to manually deliver bolus doses at mealtime (premeal) or postmeal, depending on the study phase.~Duration:~The device is used continuously throughout the entire study period, with each intervention phase (premeal vs. postmeal dosing) lasting up to 4 weeks.~Arm or Group/Intervention Cross-Reference:~This device will be us"

Trial Locations (1)

Unknown

Tel-Aviv Medical Center, Tel Aviv

All Listed Sponsors
lead

Tel-Aviv Sourasky Medical Center

OTHER_GOV