| Trial ID: | L1980 |
| Source ID: | NCT06600776
|
| Associated Drug: |
Ultra Rapid Lispro (Urli)
|
| Title: |
Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes (T1D)
|
| Interventions: |
DRUG: Ultra Rapid Lispro (URLi)|DEVICE: Insulin pump with continuous glucose monitoring (CGM)
|
| Outcome Measures: |
Primary: Percentage of Time in Glucose Range (70-180 mg/dL), The primary outcome measure is the percentage of time that blood glucose levels are within the target range of 70-180 mg/dL (Time in Range, TIR) as measured by continuous glucose monitoring (CGM). This will be compared between the mealtime dosing and postmeal dosing phases of Ultra Rapid Lispro Insulin (URLi) in patients using the MiniMed 780G hybrid closed-loop system. The outcome will be assessed from the data collected via the CareLink system throughout the intervention period., Baseline to 4 weeks post-intervention |
|
| Sponsor/Collaborators: |
Sponsor: Tel-Aviv Sourasky Medical Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-10-06
|
| Completion Date: |
2025-10-21
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-24
|
| Locations: |
Tel-Aviv Medical Center, Tel-Aviv, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT06600776
|
