Hybrid closed-loop therapy in adults with type 1 diabetes and above target HbA1c: a real-world observational study.

<p>  </p> <p>We explored longitudinal changes associated with switching to hybrid closed loop (HCL) insulin delivery systems in adults with type 1 diabetes and elevated HbA1c levels despite the use of intermittently scanned continuous glucose monitoring (isCGM) and insulin pump therapy. </p> <p><em>Research Design and Methods</em></p> <p>We undertook a pragmatic, pre-planned observational study of participants included in the NHS England closed-loop pilot. Adults using isCGM and insulin pump across 31 diabetes centers in England with a HbA1c ≥8.5%, who were willing to commence HCL therapy were included. Outcomes included change in HbA1c; sensor glucometrics; Diabetes Distress Score; Gold Score (hypoglycemia awareness); acute event rates and user opinion of HCL. </p> <h3>Results</h3> <p>In total, 570 HCL users were included; median age 40 (IQR 29-50) years, 67% female, and 85% White. Baseline HbA1c was 9.4±0.9% [78.9±9.1mmol/mol] with a median follow-up of 5.1 (IQR 3.9-6.6) months. Of 520 users continuing HCL at follow-up, mean adjusted HbA1c reduced by 1.7% (95% CI 1.5, 1.8, P<0.0001) [18.1mmol/mol; 95%CI 16.6, 19.6; P<0.0001]. Time in range (70-180mg/dL) increased from 34.2% to 61.9% (P<0.001). Individuals with HbA1c of ≤58mmol/mol rose from 0% to 39.4% (P<0.0001) and those achieving ≥70% glucose time in range and <4% time below range increased from 0.8% to 28.2% (P<0.0001). Almost all participants rated HCL therapy as having a positive impact on quality of life (94.7%, 540/570).</p> <h3>Conclusions</h3> <h3>Use of HCL is associated with improvements in HbA1c, time in range, hypoglycemia and diabetes-related distress and quality of life in people with type 1 diabetes in the real-world. </h3>