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)
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Control-IQ insulin pump with insulin using settings determined by experimental conversion factor
Control-IQ insulin pump with Humalog or Novolog using optimized insulin settings
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Time in Range (70-180 mg/dL)
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.
Time frame: 14 days
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