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Background: We assessed changes in glycemic control and person-reported outcome measures (PROMs) with t:slim X2 insulin pump with Control-IQ technology use among historically minoritized youth who are least likely to access hybrid closed loop (HCL) technology. Methods: This single-arm, prospective pilot study enrolled 15 publicly insured, insulin pump-naïve, non-Hispanic Black youth ages 6 to 250 mg/dL decreased 33.9%-points (−44.8, −23.1%; P < 0.001) or 8.1 h per day from a baseline of 69.4% (51.6, 84.0%). Median time in HCL was 78.3% (59.7, 87.3%). Youth received 10.1 (9.2, 11.9) boluses per day, 71.7% (63.8, 79.3%) of which were HCL-initiated autoboluses. Diabetes-specific quality of life increased among parents (P < 0.001) and youth (P = 0.004), and diabetes distress decreased in both groups (P < 0.001, P = 0.005). Improvements in glycemia did not correlate with any baseline youth or parent PROMs. DKA was high at baseline (67 episodes/100-person years) and did not increase during the intervention (72 episodes/100-person years, P = 0.78). Conclusion: Improvements in glycemic control and quality of life exceeding pivotal trial findings without increased safety risks among historically minoritized youth emphasize the need for equitable access to HCL systems. ClinicalTrials.gov:clinicaltrials.gov ID (NCT04807374).
Marks et al. (Fri,) studied this question.