Status:
NOT_YET_RECRUITING
Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Type 1 Diabetes (T1D)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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) ...
Eligibility Criteria
Inclusion
- Participants must be 18 years of age or older (inclusive).
- Diagnosed with Type 1 Diabetes Mellitus (T1DM).
- Already using the MiniMed 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi) for at least 2 months prior to study enrollment.
- Able and willing to provide informed consent electronically.
- Willing and able to comply with the scheduled visits and other study procedures, including remote monitoring and completing questionnaires.
Exclusion
- Participants with a medical history of untreated active proliferative retinopathy.
- Note: Subjects with non-proliferative retinopathy may be included. Subjects with treated proliferative retinopathy may be included based on the investigator's clinical judgment.
- Severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or interfere with the interpretation of study results, as judged by the investigator.
Key Trial Info
Start Date :
October 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 21 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06600776
Start Date
October 6 2024
End Date
October 21 2025
Last Update
September 24 2024
Active Locations (1)
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1
Tel-Aviv Medical Center
Tel Aviv, Israel