Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (Lpad Lyumjev)

March 20, 2026 updated by: Mark D. DeBoer, MD, MSc., MCR

Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D [Launchpad Lyumjev]

A randomized controlled trial of Control-IQ, assessing glycemic control (time-in-range 70-180 mg/dL) for Lyumjev insulin (in which the insulin settings have been determined using an experimental conversion factor) as compared to Humalog or Novolog (using optimized settings)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 be randomized to switch to Lyumjev insulin (with insulin settings determined using the conversion factor) or remain on their home Humalog or Novolog for a two-week period. Each group will have their time-in-range during the randomized phase compared to that during the baseline period.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Center for Diabetes Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥12.0 and ≤22 years old at time of consent
  2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
  3. HbA1c >6.5 - 12%
  4. Currently using insulin for at least six months
  5. Currently using the Tandem t:slim insulin pump with Control-IQ Technology® for at least two months
  6. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
  7. Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study
  8. For females, not currently known to be pregnant or breastfeeding
  9. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  10. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, prior to the insulin Optimization Phase and for the duration of the study
  11. Willingness to use Lyumjev if randomized to the experimental treatment arm
  12. Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/day
  13. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and nutraceuticals)
  14. Willingness to eat at least 1 g/kg of carbohydrate per day
  15. Willingness to check ketones per study protocol using home urine ketone strips
  16. An understanding and willingness to follow the protocol and signed informed consent

Exclusion Criteria:

  1. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
  2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
  3. Current HbA1c <6.5 or >12
  4. Pregnancy or intent to become pregnant during the trial
  5. Currently being treated for a seizure disorder
  6. Planned surgery during study duration
  7. Need for treatment with oral steroid
  8. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and nutraceuticals)
  9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lyumjev insulin using settings determined by experimental conversion factor
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.
Device: Control-IQ insulin pump with Lyumjev insulin
Control-IQ insulin pump with insulin using settings determined by experimental conversion factor
Other Names:
  • Experimental Group
Active Comparator: Humalog or Novolog using optimized insulin settings
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.
Device: Control-IQ insulin pump with Humalog or Novolog
Control-IQ insulin pump with Humalog or Novolog using optimized insulin settings
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Range (70-180 mg/dL)
Time Frame: 14 days
The primary endpoint of the clinical trial will be the difference in time in range glucose (70-180 mg/dL) by CGM (adjusted for baseline TIR) between those on the Lyumjev conversion factor and those remaining on optimized settings of Humalog/Novolog.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark D. DeBoer, MD, MSc., MCR

Collaborators

University of Virginia

Investigators

  • Principal Investigator: Mark DeBoer, MD, University of Virginia Center for Diabetes Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2025

Primary Completion (Actual)

February 27, 2026

Study Completion (Actual)

March 10, 2026

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 302376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available after publication of the manuscript.

IPD Sharing Time Frame

Data will be available for three years from the publication of the manuscript.

IPD Sharing Access Criteria

Data will be available on reasonable request after Data Sharing Agreements have been formulated.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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