A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72

Abstract

Objective: To evaluate the effect of hybrid-closed loop Control-IQ technology (Control-IQ) in randomized controlled trials (RCTs) in subgroups based on baseline characteristics such as race/ethnicity, socioeconomic status (SES), prestudy insulin delivery modality (pump or multiple daily injections), and baseline glycemic control. Methods: Data were pooled and analyzed from 3 RCTs comparing Control-IQ to a Control group using continuous glucose monitoring in 369 participants with type 1 diabetes (T1D) from age 2 to 72 years old. Results: Time in range 70-180 mg/dL (TIR) in the Control-IQ group (n = 256) increased from 57% ± 17% at baseline to 70% ± 11% during follow-up, and in the Control group (n = 113) was 56% ± 15% and 57% ± 14%, respectively (adjusted treatment group difference = 11.5%, 95% confidence interval +9.7% to +13.2%, P < 0.001), an increase of 2.8 h/day on average. Significant reductions in mean glucose, hyperglycemia metrics, hypoglycemic metrics, and HbA1c were also observed. A statistically similar beneficial treatment effect on time in range 70-180 mg/dL was observed across the full age range irrespective of race-ethnicity, household income, prestudy continuous glucose monitor use, or prestudy insulin delivery method. Participants with the highest baseline HbA1c levels showed the greatest improvements in TIR and HbA1c. Conclusion: This pooled analysis of Control-IQ RCTs demonstrates the beneficial effect of Control-IQ in T1D across a broad spectrum of participant characteristics, including racial-ethnic minority, lower SES, lack of prestudy insulin pump experience, and high HbA1c levels. The greatest benefit was observed in participants with the worst baseline glycemic control in whom the auto-bolus feature of the Control-IQ algorithm appears to have substantial impact. Since no subgroups were identified that did not benefit from Control-IQ, hybrid-closed loop technology should be strongly considered for all youth and adults with T1D. Clinical Trials Registry: clinicaltrials.gov; NCT03563313, NCT03844789, and NCT 04796779.