Closed Loop

Association of British Clinical Diabetologists

Closed Loop Nationwide Audit

 
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Graphic showing closed loop system

Above a graphic from JDRF website closed-loop insulin delivery systems require an insulin pump, continuous glucose monitor and an algorithm on a smart device. This algorithm uses the glucose data to make decisions on insulin delivery to maintain glucose levels within a pre-specified target level. When used in the real world What are the benefits? What are the problems? Are there any dangers? the audit could tell us.

 
CAM-APS Trial Data

Above In the clinical trial, glucose levels with the CAM APS FX system were significantly lower than with standard pump therapy, especially overnight. Will these improvements occur when the same system is used in the real world the audit could tell us. click the link to see the paper reporting the clinical trial

 
Tandem Control IQ Trial Data

Above In the clinical trial, compared with sensor augmented pump therapy with low glucose suspend, the Tandem Control IQ automated delivery system demonstrated reductions in HbA1c and reductions in time-below-range. Will these improvements occur when the same system is used in the real world the audit could tell us - click the link to see the paper reporting the clinical trial

 
MedTronic 780G clinical trial data

Above - In the clinical trial, the MedTronic 780G closed-loop, much like the other available systems, was associated with improved glucose levels overnight compared to sensor augmented pump therapy with predictive low glucose suspend alone. Will these improvements occur when the same system is used in the real world the audit could tell us - click the link to see the paper reporting the clinical trial

 

 

ABCD DTN-UK nationwide closed loop audit

This audit was launched in July 2021. The launch of this audit was planned to coincide with the NHS England pilot of broader criteria for closed loop use in England namely the use of closed loop systems in people already on pump therapy with FreeStyle Libre and a HbA1c≥69mmol/mol.
This audit is ABCD's third device related audit following the success of the nationwide FreeStyle Libre audit which launched in 2017 and accompanying the ABCD DIY-APS audit launched in July 2020.

What are Closed-Loop systems?
Closed-loop insulin delivery systems, sometimes called artificial pancreas systems, describe a setup where an insulin pump and continuous glucose monitor are combined with an algorithm (often held on a smart device). The glucose readings are used by the algorithm to make and communicate decisions on insulin dosing to maintain glucose levels within the target range. Evidence from clinical trials of these systems demonstrates improved time-in-range, reductions in HbA1c, reduced hypoglycaemia and improvements in quality-of-life (see links on the left).

About the ABCD DTN-UK Closed-Loop audit
NHS England have recently announced a pilot of closed loop systems in the NHS. ABCD, having previously run several successful diabetes device audits, is launching a national audit of closed loop systems. This audit will provide insight into the potential benefits of these systems in a real-world setting.
Centres involved in the closed loop roll out can collect data using the baseline and follow up forms either in paper or electronic format (see links on the right). We would encourage centres to collect data prospectively using these forms. As of 16 September, 2021, the on-line toll is live and data can now be added. Those who have been collecting data on the forms can now upload their data in bulk to the online tool. The baseline and follow-up forms can also be used for retrospective data collection of those already using closed-loop systems and that data can also be added to the on-line tool.

PLEASE REGISTER USING THE LINK:

https://abcd.care/application-join-abcd-closed-loop-audit-and-gain-access-audit-tool

Web-based audit tool
As of 16 September, 2021, the on-line tool is available for general use. The online audit tool will be held on the Health and Social Care Network (HSCN - formerly called N3) the internal NHS IT system. All data is anonymous, encrypted and GDPR compliant. As this audit is on HSCN, it can only be accessed from an NHS computer system. The tool will facilitate both local analysis and nationwide data analysis.

Structure of the audit centres and sites
For this audit the concept of centres and sites is utilised in the same way as in the other ABCD audits. Typically, a centre might be an NHS Trust. Sites might be hospitals associated with that Trust. Designated centre leads can download their local anonymised data for analysis.

Collect data on-line or via paper forms
The on-line audit tool is intended to be easy to use such that live data entry in clinic is a real option to be considered. Alternatively, if preferred, to facilitate data collection during clinics there are paper forms which exactly match the data that can be entered into the audit tool. The baseline registration form should be completed alongside a follow-up form if being completed retrospectively. You can download and print these forms locally via the link or download the PDF and complete electronically and save to your secure NHS drive (see links on the left to download the forms).

Caldicott Guardian approval
The ABCD nationwide audit programme has Caldicott Guardian approval. The programme is audit not research. The NHS encourages audit of clinical practice and there are strict guidelines which we follow, in particular that we only to collect data from routine clinical practice, and analysis is of data which is anonymised.

Further information
The Further enquiries may be made to the ABCD nationwide audits database administrator of the project, Melissa Cull

 

   Register for the closed loop audit

Access the on-line tool

Closed Loop audit objectives

Download baseline visit standard form

Download follow up visit standard form

Download the baseline visit editable form

Download the follow up visit editable form

Further information- contact us

ABCD on N3 homepage

Main ABCD homepage

Working to support high quality diabetes care in the UK