Adult Hybrid Closed Loop Study
Professor David O'Neal
Adult Hybrid Closed Loop Study
Full Project Title: Evaluation of the efficacy and cost-effectiveness of long-term hybrid closed loop insulin delivery in improving glycaemia, psychological wellbeing, sleep quality, cognition, and biochemical markers of vascular risk in adults with type 1 diabetes compared with standard care
Despite modern treatment, complications of type 1 diabetes and a reduced life expectancy continue to be a reality for patients. Almost universally, people with type 1 diabetes experience both hypoglycemia and hyperglycemia. Attempts to aggressively manage blood glucose levels in order to avoid long-term complications are limited by the risk of hypoglycemia and the personal daily burden. Hypoglycemia can lead to fear of hypoglycemia and anxiety for the individual and his/her family, affecting their quality of life. Approximately one in five adults with type 1 diabetes have impaired awareness of hypoglycemic symptoms and this is associated with a six-fold increase in the likelihood of having a severe hypoglycemic event. For the person with type 1 diabetes, repeated severe hypoglycemic events have long-lasting consequences, which impact upon quality of life and daily activities, such as driving, and place a burden on families. The average cost of a severe hypoglycemic event managed by the Australian health system is $2,431, and this does not consider costs incurred by the individual, family or community due to time off work. In 2008-2009, $214 million of healthcare expenditure was attributable to type 1 diabetes. Those with sub-optimal glycemic control are likely to have contributed disproportionally to healthcare costs.
For all of these reasons, it is essential to develop new therapies. The potential benefit of closed loop technology is to improve glycemic control, while simultaneously reducing the burden of care for people with type 1 diabetes and their families, and improving their physical well-being, psychological health and cognitive functioning. Hence, it is urgent that new and clinically effective innovations are made available to people with type 1 diabetes and translated into routine clinical practice. Hybrid closed loop (HCL) systems provide automated control of basal insulin delivery and meals that are manually announced with bolus insulin delivered according to the patient’s individualized settings. These systems offer the potential to reduce significant glycemic excursions outside of a healthy glucose range compared with conventional therapy.
Closed loop insulin delivery has the potential to revolutionize type 1 diabetes therapy. Therefore, the primary study rationale is to fill a gap in our knowledge regarding the quality of glycemic control with the use of the HCL system vs standard therapy (either multiple daily injections or continuous subcutaneous insulin infusion by insulin pump).
This was a multi-centre, randomised controlled study involving 120 adults with type 1 diabetes. The primary objectyive of the study is to compare the % time in target range, as well as glycemic excursions (either hypoglycemia or hyperglycemia) in HCL versus standard therapy. The secondary study objectives are to compare the efficacy of the HCL system vs standard therapy with regard to CGM parameters, HbA1c, daily insulin dose, diabetes complications, psychological functioning, ECG profiles, health economic measurements and biochemical markers of CVD risk.
Professor David O’Neal , Principal Investigator
Catriona Sims, Project Portfolio Manager
Dr Melissa Lee, Clinical Physician (PHD)
Dr Barbora Paldus, Clinical Physician (PHD)
Sue Anne Wyatt, Clinical Research Co-ordinator,Credentialed Diabetes Educator
Emma Netzer, Clinical Research Co-ordinator, Credentialed Diabetes Educator
Prof L Bach, The Alfred, VIC
Assoc Prof M Burt, Repatriation General Hospital, SA
Assoc Prof P Clarke, University of Melbourne, VIC
Assoc Prof N Cohen Baker, IDI Heart and Diabetes Institute, VIC
Prof P Colman, Royal Melbourne Hospital, VIC
Dr R McCallum, Royal Hobart Hospital, TAS
Dr C Hendrieckx, Deakin University, VIC
Assoc Prof DJ Holmes-Walker, Westmead Hospital, NSW
Prof AJ Jenkins, University of Sydney, NSW
Prof T Jones, Princess Margaret Hospital for Children, WA
Dr J Kaye, Sir Charles Gairdner Hospital, WA
Prof A Keech, University of Sydney, NSW
Dr K Kumareswaran, The Alfred, VIC
Prof RJ MacIsaac, St Vincent’s Hospital Melbourne, VIC
Dr SA McAuley, St Vincent’s Hospital Melbourne, VIC
Prof J Speight, Deakin University, VIC
Prof S Stranks, Repatriation General Hospital, SA
Prof V Sundararajan, St Vincent’s Hospital Melbourne, VIC
Dr S Trawley, Cairnmillar Institute, VIC
Prof GM Ward, St Vincent’s Hospital Melbourne, VIC
JDRF Australia T1DCRN
McAuley SA, de Bock MI, Sundararajan V, Lee MH, Paldus B, Ambler GR, Bach LA, Burt MG, Cameron FJ, Clarke PM, Cohen ND, Colman PG, Davis EA, Fairchild JM, Hendrieckx C, Holmes-Walker DJ, Horsburgh JC, Jenkins AJ, Kaye J, Keech AC, King BR, Kumareswaran K, MacIsaac RJ, McCallum RW, Nicholas JA, Sims C, Speight J, Stranks SN, Trawley S, Ward GM, Vogrin S, Jones TW, O'Neal DN, Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol, BMJ Open. 2018 Jun 9;8(6):e020274. doi: 10.1136/bmjopen-2017-020274
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