RECRUITING

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

Conditions

Type 1 Diabetes Continuous Glucose Monitor (CGM)Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ)Lyumjev insulin Conversion Factor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2025-07-23

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06948760

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.

Ages Eligible for Study:12 Years to 22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Sara Prince, RN

CONTACT

(434) 320-5599

SP4SA@uvahealth.org

Lianna Smith

CONTACT

(434) 284-0893

LHS7PX@uvahealth.org

Principal Investigator

Mark DeBoer, MD

PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Study Locations (Sites)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Mark D. DeBoer, MD, MSc., MCR

Mark DeBoer, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-07-23

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2025-07-23

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

Type 1 Diabetes
Continuous Glucose Monitor (CGM)
Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ)
Lyumjev insulin
Conversion Factor

Additional Relevant MeSH Terms

Type 1 Diabetes