Lpad LyumjevLyumjev Insulin for Adolescents With Type 1 Diabetes
Control-IQ insulin pump with Lyumjev insulin
+ Control-IQ insulin pump with Humalog or Novolog
Autoimmune Diseases+5
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Treatment Study
Summary
Study start date: July 23, 2025
Actual date on which the first participant was enrolled.This study focuses on improving insulin treatment for adolescents with Type 1 Diabetes (T1D) by using a faster-acting insulin called Lyumjev. The aim is to determine if Lyumjev can better manage blood sugar levels compared to the commonly used insulins, Humalog or Novolog, when used in an automated insulin delivery system. This is important because maintaining blood sugar within the target range can help prevent complications associated with diabetes and improve the quality of life for young patients. Participants in the study first go through an optimization phase with the insulin they usually use, either Humalog or Novolog, to establish a controlled baseline. Then, in a randomized phase, some participants switch to Lyumjev using a calculated conversion factor, while others continue with their usual insulin. The study observes how well each insulin controls blood sugar levels by comparing the time spent in the target range during the randomized phase to the baseline period. This approach helps identify any differences in effectiveness between the insulins, potentially offering a better treatment option for managing T1D.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 22 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Virginia Center for Diabetes Technology
Charlottesville, United StatesOpen University of Virginia Center for Diabetes Technology in Google Maps