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

NCT ID: NCT06948760

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-23
• Study Completion Date: 2026-03-31

Brief 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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Control-IQ insulin pump with Lyumjev insulin

Intervention Type: DEVICE

Control-IQ insulin pump with insulin using settings determined by experimental conversion factor

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.

Group Type: ACTIVE_COMPARATOR

Control-IQ insulin pump with Humalog or Novolog

Intervention Type: DEVICE

Control-IQ insulin pump with Humalog or Novolog using optimized insulin settings

Interventions

Control-IQ insulin pump with Lyumjev insulin

Control-IQ insulin pump with insulin using settings determined by experimental conversion factor

Intervention Type: DEVICE

Control-IQ insulin pump with Humalog or Novolog

Control-IQ insulin pump with Humalog or Novolog using optimized insulin settings

Intervention Type: DEVICE

Other Intervention Names

Experimental Group; Control Group

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Mark D. DeBoer, MD, MSc., MCR

OTHER

Sponsor Role: lead

Responsible Party

Mark D. DeBoer, MD, MSc., MCR

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mark DeBoer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Locations

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara Prince, RN

Role: CONTACT

SP4SA@uvahealth.org

(434) 320-5599

Lianna Smith

Role: CONTACT

LHS7PX@uvahealth.org

(434) 284-0893

Facility Contacts

Mark DeBoer, MD

Role: primary

MDD5Z@virginia.edu

434-924-5956

Other Identifiers

302376

Identifier Type: -

Identifier Source: org_study_id