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

StatusUnknown
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 24, 2024 (before its estimated September 21, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. Minor Publications: details revised at 7 of 7 entriesv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06600776
Lead Sponsor Tel-Aviv Sourasky Medical Center
Conditions
(from sponsor)
Type 1 Diabetes (T1D)
Related terms Diabetes Mellitus, Type 1, Patient Preference
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov