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Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT06948760•Mark D. DeBoer, MD, MSc., MCR

View on ClinicalTrials.gov

Summary

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)

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.

Eligibility

Age

12 - 22 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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.

Locations (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Key Dates

Start Date

July 23, 2025

Primary Completion Date

March 31, 2026

Completion Date

March 31, 2026

Last Updated

July 29, 2025

Enrollment

ESTIMATED participants

Conditions

Type 1 Diabetes

Interventions

Control-IQ insulin pump with Lyumjev insulin

DEVICE

Control-IQ insulin pump with Humalog or Novolog

DEVICE

Contacts

Sara Prince, RN

CONTACT

(434) 320-5599 SP4SA@uvahealth.org

Lianna Smith

CONTACT

(434) 284-0893 LHS7PX@uvahealth.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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