Hybrid Closed Loop Systems Improve Glycemic Control and Quality of Life in Historically Minoritized Youth with Diabetes.

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 <21 years with type 1 diabetes and hemoglobin A1c (HbA1c) ≥10% in a 6-month study of HCL use. The primary outcome was absolute change in time in range (TIR) (70-180 mg/dL). Secondary outcomes included other continuous glucose monitor metrics, PROMs, and diabetic ketoacidosis (DKA) incidence.

Results

For 13 youth (median 14.8 years, 53.3% female, HbA1c 11.7%) who completed the study, baseline TIR of 12.3% (6.3-27.1%) increased 23.7%-points (16.9, 30.5%; P < 0.001) or 5.7 h per day. Percent time >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).