Randomized, Crossover Trial of Control-IQ Technology with a Lower Treatment Range and a Modified Meal Bolus Module in Adults, Adolescents, Children, and Preschoolers with Varying Levels of Baseline Glycemic Control
Authors' conclusion
The lower treatment range and late bolus feature of the modified Control-IQ system were safe for use in all age-groups. TIR and TITR improved with LR regardless of baseline HbA1c.
Study context
- Population
- Adults, adolescents, children and preschoolers with T1D, aged 3–57 yearscompleted the study
- Participants
- 72 adults
- Comparison
- Modified Control-IQ with lower treatment range (LR, 90-130 mg/dL) vs standard range (SR, 112.5-160 mg/dL) vs run-in (Control-IQ v1.5)
Methodological detailsmulticenter, at home in random order, Two late bolus meal challenges per 2-week period, bolusing 45 min after meals with and without a new late bolus feature
- Multicenter
- At home in random order
- Two late bolus meal challenges per 2-week period, bolusing 45 min after meals with and without a new late bolus feature
Primary result
As reported in the abstract
TIR 70-180 mg/dL
Difference
+3.1%
P < 0.001
LR vs Run-in
Difference
+2.1%
P < 0.001
LR vs SR
LR
68.0%
Further findings
| Outcome | Difference | P value |
|---|---|---|
| Time in tight range (TITR) 70-140 mg/dLLR vs Run-in | +3.3% | P < 0.001 |
| Time in tight range (TITR) 70-140 mg/dLLR vs SR | +4.0% | P < 0.001 |
Time in tight range (TITR) 70-140 mg/dL
- Similar improvements with LR for time >180 mg/dL and mean glucose
Time in range (TIR) and TITR by baseline hemoglobin A1c (HbA1c)
- Lower baseline HbA1c: highest TIR and TITR with LR; higher baseline HbA1c: greatest improvements in TIR and TITR
Safety
- There were no diabetic ketoacidosis or severe hypoglycemia events
- All meal challenges were completed safely
Original publication
Randomized, Crossover Trial of Control-IQ Technology with a Lower Treatment Range and a Modified Meal Bolus Module in Adults, Adolescents, Children, and Preschoolers with Varying Levels of Baseline Glycemic Control. Diabetes Technol Ther. Published 26 November 2024. doi:10.
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