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).

Real-World Glycemic Outcomes with Early Omnipod 5 Use in Youth with Type 1 Diabetes.

Background: Pivotal trials of diabetes technologies have demonstrated glycemic improvements; however, these trials include patients of limited diversity and ranges of glycemic control. We assessed changes in glycemic control during the first 90 days of Omnipod 5 use in a real-world cohort of youth with type 1 diabetes (T1D). Methods: Youth 2-21 years with T1D initiating Omnipod 5 at two pediatric academic centers were included. Fourteen days of baseline (BL) continuous glucose monitoring (CGM) data were compared against data from the first 90 days of Omnipod 5 use. Outcome measures included changes in time in range (TIR), hemoglobin A1c (HbA1c), and CGM and insulin pump metrics based on the duration of Omnipod 5 use. Results: Among 195 youth (78.9% non-Hispanic White, 15.4% publicly insured, age 11.7 years, T1D duration 3.3 years) TIR increased 11%-points, from 49% to 61% (P < 0.001), and HbA1c decreased 0.5%-points, from 7.5% to 6.9% (P < 0.001). TIR improved within the first 9 days of Omnipod 5 use (p < 0.001) and did not change significantly thereafter (P = 0.1) despite decreases in user-initiated boluses (5.1 vs. 5.0, P = 0.01) and carbohydrate entries (4.2 vs. 4.1, P = 0.005) from days 1-9 to days 1-90. TIR improved 15%-points among youth with BL TIR <60% compared to a 5%-point increase for youth with BL TIR ≥60% (P < 0.001). Conclusions: Glycemic control improved within 9 days of Omnipod 5 initiation in this real-world cohort, and improvements were sustained over the first 90 days of use despite concomitant decreases in user-initiated boluses. These improvements were comparable to those observed in the pivotal trial.

Differences in positive expectancy of hybrid closed loop (HCL) insulin delivery systems do not explain racial differences in HCL use.

Aims: Hybrid closed loop (HCL) insulin delivery systems improve glycemia and quality of life among youth with type 1 diabetes (T1D), however there are inequities in use. We aimed to evaluate whether differences in positive expectancy of HCL systems may explain differences in use. Methods: Fifteen publicly-insured, non-Hispanic Black (NHB) youth with hemoglobin A1C (HbA1c) ≥ 10% enrolled in a study exploring changes in glycemia and person reported outcomes (PRO) during 6 months of Tandem t:slim X2 insulin pump with Control-IQ technology. At baseline youth and parents completed PROs, including Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) survey assessing positive expectancy of HCL use, and Problem Areas in Diabetes (PAID) survey assessing diabetes-related distress. Differences between this cohort and the Tandem Control-IQ pediatric pivotal trial (DCLP5) cohort were assessed. Results: As compared to the DCLP5 cohort (0% NHB, 10% publicly-insured), baseline glycemic indicators were suboptimal (MHbA1c 11.9 ± 1.4% vs 7.6 ± 0.9%, p < 0.0001; continuous glucose monitor (CGM) time-above-range > 180 mg/dL 82 ± 15% vs 45 ± 18%, p < 0.0001). INSPIRE scores in both cohorts were equally high among youth (80 ± 10 vs 77 ± 13, p = 0.41) and parents (88 ± 14 vs 85 ± 11, p = 0.37). PAID scores were higher among parents (68 ± 19 vs 43 ± 16, p < 0.0001), but not youth (43 ± 16 vs 35 ± 16, p = 0.09) in the historically marginalized cohort as compared to the DCLP5 cohort. Conclusions: Despite differences in glycemic control and diabetes related burden, positive expectancy of HCL systems is comparable among historically marginalized youth with T1D and the predominantly non-Hispanic White, privately insured DCLP5 cohort. These findings suggest that differences in perceptions of HCL technology may not explain inequities in use.