24/7 closed-loop in older subjects with type 1 diabetes
Research type
Research Study
Full title
An open-label, multi-centre, randomised, two-period, crossover study to assess the efficacy, safety and utility of 16 week day and night automated closed-loop glucose control combined with pump suspend feature under free living conditions compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes
IRAS ID
225510
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Summary of Research
The main objective of this study is to determine whether automated day and night closed-loop insulin delivery combined with pump suspend feature for 16 weeks under free living conditions is safer and more effective compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes. \n\nThis is an open-label, multi-centre, randomised, crossover design study, involving a 4-6 week run-in period, followed by two 4 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by sensor-augmented pump therapy, in random order. A total of up to 42 adults (aiming for 36 completed subjects) aged 60 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. \n\nSubjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. \n\nThe primary outcome is time spent in target glucose range between 3.9 and 10.0 mmol/L as recorded by continuous glucose sensor measurements. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by glucose sensor, and other glucose sensor-based metrics. Measures of human factor assessment, cardiac rhythm and objective sleep quality assessment will also be evaluated in this study.Summary of Results
The number of older adults (aged 60 years and over) with type 1 diabetes is growing because more people are being diagnosed with type 1 diabetes and advancements in diabetes care have also led to increased longevity. Management of diabetes in older adults can be challenging due to increased risk of dangerously low glucose levels (severe hypoglycaemia), and the presence of other medical conditions. We aimed to compare glucose control when participants used a hybrid closed-loop system for 4 months to when they used a glucose sensor and insulin pump (sensor augmented pump therapy) for 4 months. The order of the two periods was random.
This multinational randomised controlled trial, carried out at four centres (Cambridge, Manchester and Birmingham, UK and Graz, Austria), involved 37 older adults with type 1 diabetes. The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and was sponsored by the University of Cambridge and Cambridge University Hospitals NHS Trust. The research was led by Professor Roman Hovorka’s artificial pancreas team (University of Cambridge Metabolic Research Laboratories).
The results showed that participants spent an average of two additional hours each day with glucose levels in the target range (3.9 to 10.0mmol/L) when they used the closed-loop system (80%), compared to when they used sensor augmented pump therapy (71%). Participants spent less time with glucose levels above target (> 10.0mmol/L) when they used the closed-loop system compared to when they used sensor augmented pump therapy. Importantly the improved glucose control was achieved without any increase in time with glucose levels in the hypoglycaemic range (<3.9 mmol/L). There were no severe hypoglycaemia events during the period when participants used the closed-loop system but two severe hypoglycaemia events during the sensor augmented pump period.
This study showed that hybrid closed-loop insulin delivery is safe and improved glucose control in older adults (aged 60 years and over) with type 1 diabetes without increasing the risk of hypoglycaemia. The study has been published in Lancet Healthy Longevity (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbTIv-2Ft3HPwp9ygyfRmTQm9XssVc05YGkLWrQ6LcM-2FWBKA-2Fsr9q93d3uiVUoKsfkUV7UljB7izqyflMeflsHo3F6sFSuQl-2BxTC3PxAXjKwB1tnqah_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIHpA-2F5R7QMbqGhW-2BDqVfDC0tXaK6TowQhzp9mnWKOccl7mo5Wm1vwYRg0dhPkgBtr3u8wLfdqMVTmJ2XU8RZv6FilNLiYG63V63Zr6MZuV3h7Jz-2BTLUHulxWLaeNu0XPCSVduYOPb-2BJVx9XoDQ8wf6QtSRyvrbW1OQADS1b3LO5Q-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C9fc361a13ec44a6200b408db00749a90%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638104273024380687%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ANo8IURrgphXawYPTWOcedaKlCdRzgXPHa55T%2FGkS3w%3D&reserved=0 and provides important evidence to support wider adoption of hybrid closed-loop therapy as an important treatment option for this population in clinical practice.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0394
Date of REC Opinion
25 Jul 2017
REC opinion
Favourable Opinion