64 research outputs found

    Correction to: New closed-loop insulin systems.

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    A Correction to this paper has been published: 10.1007/s00125-021-05443-1</jats:p

    CamAPS FX hybrid closed-loop with ultra-rapid lispro compared with standard lispro in adults with type 1 diabetes: a double-blind, randomized, crossover study.

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    INTRODUCTION To evaluate hybrid closed-loop with ultra-rapid insulin lispro (Lyumjev) compared with hybrid closed-loop with standard insulin lispro in adults with type 1 diabetes. MATERIALS AND METHODS In a single-center, double-blind, randomized, crossover study, 28 adults with type 1 diabetes (mean±SD: age 44.5±10.7, HbA1c 7.1±0.9% [54±10mmol/mol]) underwent two 8-week periods comparing hybrid closed-loop with ultra-rapid insulin lispro and hybrid closed-loop with standard insulin lispro in random order. CamAPS FX closed-loop system was used in both periods. RESULTS In an intention-to-treat analysis, the proportion of time sensor glucose was in target range (3.9 to 10mmol/L; primary endpoint) was greater with ultra-rapid lispro compared with standard insulin lispro (mean±SD: 78.7±9.8% vs. 76.2±9.6%; mean difference 2.5 percentage points [95%CI 0.8 to 4.2]; p=0.005). Mean sensor glucose was lower with ultra-rapid lispro compared with standard insulin lispro (7.9±0.8mmol/L vs. 8.1±0.9mmol/L; p=0.048). The proportion of time with sensor glucose <3.9mmol/L was similar between interventions (median [IQR] ultra-rapid lispro 2.3% [1.3-2.7%] vs. standard insulin lispro 2.1% [1.4-3.3%]; p=0.33). No severe hypoglycemia or ketoacidosis occurred. CONCLUSIONS The use of ultra-rapid lispro with CamAPS FX hybrid closed-loop increases time in range and reduces mean glucose with no difference in hypoglycemia compared with standard insulin lispro in adults with type 1 diabetes

    What Training, Support, and Resourcing Do Health Professionals Need to Support People Using a Closed-Loop System? A Qualitative Interview Study with Health Professionals Involved in the Closed Loop from Onset in Type 1 Diabetes (CLOuD) Trial.

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    Background: We explored health professionals' views about the training, support, and resourcing needed to support people using closed-loop technology in routine clinical care to help inform the development of formal guidance. Methods: Interviews were conducted with health professionals (n = 22) delivering the Closed Loop from Onset in Type 1 Diabetes (CLOuD) trial after they had ≥6 months' experience of supporting participants using a closed-loop system. Data were analyzed descriptively. Results: Interviewees described how, compared with other insulin regimens, teaching and supporting individuals to use a closed-loop system could be initially more time-consuming. However, they also noted that after an initial adjustment period, users had less need for initiating contact with the clinical team compared with people using pumps or multiple daily injections. Interviewees highlighted how a lessened need for ad hoc clinical input could result in new challenges; specifically, they had fewer opportunities to reinforce users' diabetes knowledge and skills and detect potential psychosocial problems. They also observed heightened anxiety among some parents due to the constant availability of data and unrealistic expectations about the system's capabilities. Interviewees noted that all local diabetes teams should be empowered to deliver closed-loop system care, but stressed that health professionals supporting closed-loop users in routine care will need comprehensive technology training and standardized clinical guidance. Conclusion: These findings constitute an important starting point for the development of formal guidance to support the rollout of closed-loop technology. Our recommendations, if actioned, will help limit the potential additional burden of introducing closed-loop systems in routine clinical care and help inform appropriate user education and support.NIHR Wellcome Trust Strategic Award (100574/Z/12/Z

    Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial

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    Funder: CB was supported by a grant from The Novo Nordisk UK Research FoundationFunder: LB was supported by a grant of the Swiss Society for Endocrinology and a grant of the Diabetes and Swiss Kidney Foundation.Funder: Supported by National Institute for Health Research Cambridge Biomedical Research Centre.Abstract: We evaluated the safety and efficacy of fully closed-loop insulin therapy compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis. In an open-label, multinational, two-center, randomized crossover trial, 26 adults with type 2 diabetes requiring dialysis (17 men, 9 women, average age 68 ± 11 years (mean ± s.d.), diabetes duration of 20 ± 10 years) underwent two 20-day periods of unrestricted living, comparing the Cambridge fully closed-loop system using faster insulin aspart (‘closed-loop’) with standard insulin therapy and a masked continuous glucose monitor (‘control’) in random order. The primary endpoint was time in target glucose range (5.6–10.0 mmol l−1). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6–10.0 mmol l−1; primary endpoint) was 52.8 ± 12.5% with closed-loop versus 37.7 ± 20.5% with control; mean difference, 15.1 percentage points (95% CI 8.0–22.2; P < 0.001). Mean glucose was lower with closed-loop than control (10.1 ± 1.3 versus 11.6 ± 2.8 mmol l−1; P = 0.003). Time in hypoglycemia (<3.9 mmol l−1) was reduced with closed-loop versus control (median (IQR) 0.1 (0.0–0.4%) versus 0.2 (0.0–0.9%); P = 0.040). No severe hypoglycemia events occurred during the control period, whereas one severe hypoglycemic event occurred during the closed-loop period, but not during closed-loop operation. Fully closed-loop improved glucose control and reduced hypoglycemia compared with standard insulin therapy in adult outpatients with type 2 diabetes requiring dialysis. The trial registration number is NCT04025775
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