Recruiting

Lpad LyumjevLyumjev Insulin for Adolescents With Type 1 Diabetes

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What is being tested

Control-IQ insulin pump with Lyumjev insulin

+ Control-IQ insulin pump with Humalog or Novolog

Device
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 12 to 22 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorMark D. DeBoer, MD, MSc., MCR
Study ContactSara Prince, RNMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTesting a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D [Launchpad Lyumjev]
Principal SponsorMark D. DeBoer, MD, MSc., MCR
Study ContactSara Prince, RNMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

16 inclusion criteria required to participate
Age ≥12.0 and ≤22 years old at time of consent

Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year

HbA1c >6.5 - 12%

Currently using insulin for at least six months

Show More Criteria

9 exclusion criteria prevent from participating
History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment

Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment

Current HbA1c <6.5 or >12

Pregnancy or intent to become pregnant during the trial

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then use Lyumjev insulin for a two-week period with insulin settings determined using the conversion factor.

Group II

Active Comparator
All participants will have a physician-driven insulin Optimization Phase using their home Humalog or Novolog in the Control-IQ control group. After this, participants will have a two-week baseline control phase to assess time-in-range on the optimized insulin settings. Participants will then remain on their home Humalog or Novolog for a two-week period using the optimized insulin settings. Each group will have their time-in-range during the randomized phase compared to that during the baseline period.

Study 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

Recruiting

University of Virginia Center for Diabetes Technology

Charlottesville, United StatesOpen University of Virginia Center for Diabetes Technology in Google Maps
Recruiting
One Study Center