NCT06600776

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

A Pilot Study Comparing the Efficacy of Dosing Ultra Rapid Insulin Lispro in a Medtronic 780G Hybrid Closed Loop System at Mealtime or Postmeal

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to compare premeal to postmeal dosing of ultra rapid lispro insulin (URLi) used in a MiniMed 780G system hybrid closed loop system. Subjects with type 1 diabetes mellitus (T1DM) already using a 780G hybrid closed loop system with URLi will be included. After signing a remote digital informed consent, a baseline record of the MiniMed 780G system will be downloaded from the Medtronic digital platform (Carelink system \[1\]) and subjects will be asked to fill an online questionnaire regarding their time of insulin dosing preferences and a 3-day online food diary \[2\]. During the intervention period subjects will be asked to provide a bolus dose of insulin only at the end of meals for up to 4 weeks. During the last week of the intervention period, subjects will be asked to fill out a 3-day online food diary \[2\]. At the end of the intervention period- a Carelink report \[1\] will be collected remotely and subjects will be asked to fill again the online questionnaire regarding their time of dosing preferences. 1. Primary Objective: To assess the efficacy of premeal dosing to post-meal dosing on parameters of glycemic control as obtained from continuous glucose monitoring. 2. Secondary Objective: To assess patient dosing preferences and the effect of premeal dosing vs. post-meal dosing on patient reported outcomes Ref: 1. carelink.medtronic.eu 2. NutRatio.com.

Conditions

• Type 1 Diabetes (T1D)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-06
• Primary completion: 2025-09-21
• Completion: 2025-10-21
• First posted: 2024-09-19
• Last updated: 2024-09-24

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study
• FDA-regulated device study