2IQP
Trial question
What is the role of automated insulin delivery in patients with insulin-treated T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 319
319 patients (154 female, 165 male).
Inclusion criteria: adult patients with insulin-treated T2DM.
Key exclusion criteria: receipt of hybrid closed-loop system; receipt of systemic corticosteroids, sulfonylurea, meglitinide, or hydroxyurea; hemoglobinopathy or other condition expected to affect the measurement of HbA1c; pregnancy or lactation.
Interventions
N=215 automated insulin delivery (t:slim X2™ insulin pump with Control-IQ™ technology version 1.5 plus continuous glucose monitoring for 13 weeks).
N=104 standard therapy (continuation of pretrial insulin delivery regimen plus continuous glucose monitoring).
Primary outcome
Reduction in mean hemoglobin A1c level at 13 weeks
0.9%
0.3%
0.9 %
0.7 %
0.5 %
0.2 %
0.0 %
Automated insulin
delivery
Standard
therapy
Significant
increase ▲
NNT = 166
Significantly greater reduction in mean HbA1c level at 13 weeks (0.9% vs. 0.3%; MD 0.6, 95% CI 0.4 to 0.8).
Secondary outcomes
Significantly greater improvement in mean time with target glucose range of 70-180 mg/dL at 13 weeks (16% vs. 1%; MD 14, 95% CI 11 to 17).
Significantly greater reduction in mean glucose level at 13 weeks (24 mg/dL vs. 2 mg/dL; MD 21, 95% CI 15 to 26).
Significant decrease in the number of prolonged hyperglycemia events (0.9 events/week vs. 1.6 events/week; MD -0.7, 95% CI -1 to -0.4).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with insulin-treated T2DM, automated insulin delivery was superior to standard therapy with respect to reduction in mean HbA1c level at 13 weeks.
Reference
Yogish C Kudva, Dan Raghinaru, John W Lum et al. A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes. N Engl J Med. 2025 Mar 19. Online ahead of print.
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