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

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Sep 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into how the timing of insulin doses affects blood sugar control in people with Type 1 Diabetes who use a specific insulin pump called the MiniMed 780G. Specifically, it will compare giving ultra rapid lispro insulin (URLi) before meals versus after meals. Participants will already be using the pump with URLi for at least two months. To join, you need to be 18 or older, have Type 1 Diabetes, and be willing to complete some online questionnaires and food diaries.

If you participate, you will first share your usual insulin dosing preferences and track what you eat for a few days. Then, for about four weeks, you’ll only take your insulin after meals. At the end, you'll again fill out a food diary and share your thoughts on the dosing timing. This study aims to understand which method might help control blood sugar better and how people feel about each dosing option. It's important to note that individuals with certain eye conditions or severe health issues may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.