Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study.

Background: Older adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes. Methods: In an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762. Findings: 38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63-70] years, mean [SD] baseline glycated haemoglobin [HbA1c]; 7·4% [0·9%]; 57 [10] mmol/mol) were randomly assigned between Sept 4, 2019, and Oct 2, 2020. The proportion of time with glucose between 3·9 and 10·0 mmol/L was significantly higher in the closed-loop group compared to the SAP group (79·9% [SD 7·9] vs 71·4% [13·2], difference 8·6 percentage points [95% CI 6·3 to 11·0]; p<0·0001). Two severe hypoglycaemia events occurred during the SAP period. There were two non-treatment related serious adverse events: cardiac arrest from pulmonary embolism associated with COVID-19 during the SAP period resulting in death, and a hospital presentation for parenteral hydrocortisone because of COVID-19 in a participant with adrenal insufficiency during the run-in period. Interpretation: Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes.

Impact of COVID-19 restrictions on diabetes health checks and prescribing for people with type 2 diabetes: a UK-wide cohort study involving 618 161 people in primary care.

OBJECTIVE: To compare rates of performing National Institute for Health and Care Excellence-recommended health checks and prescribing in people with type 2 diabetes (T2D), before and after the first COVID-19 peak in March 2020, and to assess whether trends varied by age, sex, ethnicity and deprivation. METHODS: We studied 618 161 people with T2D followed between March and December 2020 from 1744 UK general practices registered with the Clinical Practice Research Datalink. We focused on six health checks: haemoglobin A1c, serum creatinine, cholesterol, urinary albumin excretion, blood pressure and body mass index assessment. Regression models compared observed rates in April 2020 and between March and December 2020 with trend-adjusted expected rates derived from 10-year historical data. RESULTS: In April 2020, in English practices, rates of performing health checks were reduced by 76%-88% when compared with 10-year historical trends, with older people from deprived areas experiencing the greatest reductions. Between May and December 2020, the reduced rates recovered gradually but overall remained 28%-47% lower, with similar findings in other UK nations. Extrapolated to the UK population, there were ~7.4 million fewer care processes undertaken March-December 2020. In England, rates for new medication fell during April with reductions varying from 10% (95% CI: 4% to 16%) for antiplatelet agents to 60% (95% CI: 58% to 62%) for antidiabetic medications. Overall, between March and December 2020, the rate of prescribing new diabetes medications fell by 19% (95% CI: 15% to 22%) and new antihypertensive medication prescribing fell by 22% (95% CI: 18% to 26%), but prescribing of new lipid-lowering or antiplatelet therapy was unchanged. Similar trends were observed across the UK, except for a reduction in new lipid-lowering therapy prescribing in the other UK nations (reduction: 16% (95% CI: 10% to 21%)). Extrapolated to the UK population, between March and December 2020, there were ~31 800 fewer people with T2D prescribed a new type of diabetes medication and ~14 600 fewer prescribed a new type of antihypertensive medication. CONCLUSIONS: Over the coming months, healthcare services will need to manage this backlog of testing and prescribing. We recommend effective communications to ensure patient engagement with diabetes services, monitoring and opportunities for prescribing, and when appropriate use of home monitoring, remote consultations and other innovations in care.

COVID-19: Impact of and on Diabetes.

Diabetes has been identified as a pre-existing health condition linked with worse outcomes following coronavirus disease 2019 infection. Here we explore the association between hyperglycaemia and more severe illness, the impact of the pandemic on diabetes service delivery, and the resultant opportunities for innovation.

Impact of COVID-19 lockdown on flash and real-time glucose sensor users with type 1 diabetes in England.

AIMS: People with type 1 diabetes (T1D) face the daily task of implementing self-management strategies to achieve their glycaemic goals. The UK COVID-19 lockdown has had an impact on day-to-day behaviour, which may affect diabetes self-management and outcomes. We assessed whether sensor-based outcomes pre- and during lockdown periods were different in a cohort of glucose sensor users with T1D. METHODS: Data were collected from Freestyle Libre (FSL) or Dexcom G6 sensor users who remotely shared their data with the diabetes clinic web platform. Sensor metrics according to international consensus were analysed and compared between pre-lockdown period and 2 and 3 weeks into lockdown (periods 1 and 2). RESULTS: Two hundred and sixty-nine T1D patients (baseline HbA1c 57 ± 14 mmol/mol) were identified as FSL (n = 190) or Dexcom G6 (n = 79) users. In patients with sensor use > 70% (N = 223), compared to pre-lockdown period percentage TIR 3.9-10 mM (TIR) significantly increased during period 1 (59.6 ± 18.2 vs. 57.5 ± 17.2%, p = 0.002) and period 2 (59.3 ± 18.3 vs. 57.5 ± 17.2%, p = 0.035). The proportion of patients achieving TIR ≥ 70% increased from 23.3% pre-lockdown to 27.8% in period 1 and 30.5% in period 2. A higher proportion also achieved the recommended time below and above range, and coefficient of variation in periods 1 and 2. Dexcom G6 users had significantly lower % time below range (< 3.9 mM) compared to FSL users during both lockdown periods (period 1: Dexcom G6 vs. FSL: 1.8% vs. 4%; period 2: 1.4% vs. 4%, p < 0.005 for both periods). CONCLUSION: Sensor-based glycaemic outcomes in people with T1D in the current cohort improved during COVID-19 lockdown, which may be associated with positive changes in self-management strategies. Further work is required to evaluate long-term sustainability and support.