An interventional study of Control-IQ insulin pump with Lyumjev insulin and Control-IQ insulin pump with Humalog or Novolog in Type 1 Diabetes, sponsored by Mark D. DeBoer, MD, MSc., MCR. Completed at 1 site in United States. Open to participants aged 12 Years to 22 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Mark D. DeBoer, MD, MSc., MCR · Not applicable, Interventional, and Treatment
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Mark D. DeBoer, MD, MSc., MCR is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Device: Control-IQ insulin pump with Lyumjev insulin
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.
Device: Control-IQ insulin pump with Humalog or Novolog
Control-IQ insulin pump with insulin using settings determined by experimental conversion factor
Also known as: Experimental Group
Control-IQ insulin pump with Humalog or Novolog using optimized insulin settings
Also known as: Control Group
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified data will be made available after publication of the manuscript.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Mark D. DeBoer, MD, MSc., MCR