NCT06948760

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]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Mark D. DeBoer, MD, MSc., MCR · Academic / Other
• Sex: All
• Age: 12 Years – 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Control-IQ insulin pump with Lyumjev insulin	Control-IQ insulin pump with insulin using settings determined by experimental conversion factor
DEVICE	Control-IQ insulin pump with Humalog or Novolog	Control-IQ insulin pump with Humalog or Novolog using optimized insulin settings

Timeline

• Start date: 2025-07-23
• Primary completion: 2026-02-27
• Completion: 2026-03-10
• First posted: 2025-04-29
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study