Summary

NHS England (NHSE) and Association of British Clinical Diabetologists (ABCD) DTN-UK worked to deliver and evaluate the adult Hybrid Closed Loop (HCL) pilot. The results have been presented at international meetings and submitted for publication. Most importantly, the data from 520 users was submitted to NICE and made a significant impact on the cost-effectiveness evaluation of the NICE HCL multiple technology appraisal recommendations. These are currently in draft form, with a full updated version being released soon, enabling improved care of for over 100,000 people living with type 1 diabetes in England and Wales.

Innovation

Never before has novel, automated, life changing diabetes technology been delivered at such scale and over a such a short period. The HCL pilot accelerated understanding of not only the clinical and psychological benefits but also how best to deliver at scale. Fortnightly catch-up meetings covered safe practice and successful delivery. The ABCD DTN-UK used an innovative, secure online tool to capture data from over 500 users over a short space of time. Previously, no study had evaluated the real-world outcomes of this technology in such a large and highrisk population. The results informed the NICE cost-effectiveness evaluation. HCP experiences from the pilot informed the development of ABCD-DTN-UK National Best Practice Guide for HCL therapy. The pilot provided real-world evidence on the glycaemic benefits of HCL therapy and learning to guide large-scale onboarding.

Dissemination and Sustainability

The HCL pilot was delivered across many centres to over 500 people living with type 1 diabetes from a broad range of backgrounds, inlcuding 37% from the two most deprived quintiles and 9% from a non-white background. The pilot demonstrated uniform outcomes regardless of demographics. People who would not typically have taken part in a randomised controlled trial were able to access HCL therapy. The learnings will support the implementation of this life-changing technology at scale, when the NICE TA recommendations go live later in 2023.

Implementation of New Technologies

In 2021 Simon Stevens announced that NHSE could pilot HCL technology. This technology keeps glucose levels in range by automating insulin delivery. In clinical trials it improves glucose levels and quality of life; however, trials focused on safety, underestimating impact compared to real-world clinical experience. The NHSE pilot investigated the real-world benefits of these systems at a wide scale. The pilot population was medically complex, with an HbA1c ≥8.5% (≥69mmol/mol), despite a high level of care with an insulin pump and intermittently scanned continuous glucose monitoring (isCGM). A total of 31 adult diabetes MDTs across England started the participants on HCL between August and December 2021. Coordination and support from NHS England, DTN-UK and clinical leads was essential to ongoing engagement, robust data collection and liaison with industry. Data demonstrated a significant improvement in HbA1c and diabetesrelated distress. This was one of the most significant datasets used for the NICE TA recommendations. The objectives were: to discover whether HCL could help people with diabetes manage their condition safely and effectively in a real-world setting; to evaluate whether it could improve outcomes over the combination of an insulin pump and flash glucose monitoring in people living with diabetes with an elevated HbA1c; to gain insight into the challenges of delivering this technology at scale. NHS England led and funded the pilot. The ABCD HCL study was designed to capture routine anonymised outcome data from adults who participated in the NHS England closed loop pilot. The aim was to assess the real-world effectiveness and safety of HCL systems commercially available in the UK in an NHS outpatient setting. The 31 teams provided evidence to ABCD, which was submitted to NICE to inform its technology appraisal. The resulting recommendations, which widen access to HCL, will fundamentally alter the standard of care in type 1 diabetes. A pragmatic, observational study of participants was undertaken, along with a mixed-methods study to explore the impact on people living with diabetes and their families. Longitudinal changes associated with commencing HCL in adults with type 1 diabetes and elevated HbA1c levels despite the use of isCGM and insulin pump therapy were explored. Patient-reported outcomes were also captured. Outcomes included: change in HbA1c; sensor glucometrics; diabetes distress score; gold score (hypoglycaemia awareness); acute event rates and user opinion of HCL. In total, 570 HCL users took part. They had a median age of 40, 67% were female and 85% White. Baseline HbA1c was 9.4±0.9% (78.9±9.1mmol/mol) with median follow-up of 5.1 months. Of 520 continuing HCL at follow-up, mean adjusted HbA1c reduced by 1.7% (18.1mmol/mol). Time in range (70-180mg/dL) increased from 34.2% to 61.9%. Individuals with HbA1c of ≤7.5% (≤58mmol/mol) at baseline rose from 0% to 39.4% and those achieving ≥70% time in range and <4% time below range increased from 0.8% to 28.2%. Almost all rated HCL therapy as having a positive impact on quality of life (94.7%). Data demonstrated a vast improvement in glucose control (HbA1c -18.1mmol/mol), diabetes-related distress reduced (69% to 22%). In total, 125 participants completed post-intervention INSPIRE, DTSQc and bespoke questionnaires. Total score for INSPIRE was 88/100 and DTSQc scored 17/18, indicating high levels of satisfaction. Importantly, 98.4% of respondents were more satisfied with HCL therapy than insulin pump and isCGM therapy. HCL therapy was deemed more flexible and convenient. It was associated with improvements in HbA1c, time in range, hypoglycaemia and diabetes-related distress and real-world quality of life. The 2023 NICE Technology Appraisal recommends wide access. Reported hospital admissions related to hypoglycaemia and hyperglycaemia/ DKA and paramedic callouts (not resulting in admission) were low and no increase in per 10-person/year events was observed. A total of 37 adverse events were reported, the majority related to either pump or cannula issues or sensor failures, inaccuracies and skin reactions. A total of 50 users (8.8%) discontinued therapy. Retinopathy outcomes showed progression within usual rates. From the quantitative questionnaires, 87% and 76% felt HCL reduced their perceived risk of long-term complications and the burden of hypoglycaemia, respectively. NHSE provided funding for the CGM to enable transfer from pump alone to HCL. ABCD DTN-UK funded the national audit.