<\/p>\n
Project updates:<\/h3>\n
[\/et_pb_text][et_pb_accordion admin_label=”Project updates accordion:right” _builder_version=”3.17.6″][et_pb_accordion_item _builder_version=”3.17.6″ title=”October 2021″]<\/p>\n
The FLASH-UK study has reached the major milestone of Last Participant Last Visit (LPLV) from the 156 participants that were recruited to the trial.<\/p>\n
We would like to express our utmost appreciation to sites for all of their hard work and going the extra mile during the unprecedented circumstances that all teams faced with COVID-19.<\/p>\n
We look forward to working with sites on the closeout of the trial and look forward to sharing the findings in 2022.<\/p>\n
[\/et_pb_accordion_item][et_pb_accordion_item _builder_version=”3.17.6″ title=”April 2021″]<\/p>\n
The FLASH-UK study has reached a milestone of 150 participants, with 74 randomisations in the Flash Blood Glucose Monitoring with Freestyle Libre group and 76 in the self-monitoring group.<\/p>\n
Randomisations by site<\/h3>\n\n- Birmingham (University Hospitals Birmingham NHS Foundation Trust): 9<\/li>\n
- Cambridge (Cambridge University Hospitals NHS Foundation Trust): 30<\/li>\n
- Derby (University Hospitals of Derby & Burton NHS Foundation Trust): 24<\/li>\n
- Dorset (University Hospitals Dorset NHS Foundation Trust): 13<\/li>\n
- Ipswich (East Suffolk and North Essex NHS Foundation Trust): 19<\/li>\n
- Manchester (Manchester University NHS Foundation Trust): 28<\/li>\n
- Norwich (Norfolk & Norwich University Hospitals NHS Foundation Trust): 18<\/li>\n
- Portsmouth (Portsmouth Hospitals NHS Trust): 9<\/li>\n<\/ul>\n
We would like to express our utmost appreciation to sites for all of their hard work. This has enabled us to hit our recruitment target, especially when faced with the unprecedented COVID period.<\/p>\n
We look forward to working with sites on the follow-up and retention of all participants.<\/p>\n
[\/et_pb_accordion_item][et_pb_accordion_item _builder_version=”3.17.6″ title=”February 2021″]<\/p>\n
The FLASH-UK study has reached a milestone of 100 participants, with 49 randomisations in the Flash Blood Glucose Monitoring with Freestyle Libre group and 51 in the self-monitoring group.<\/p>\n
Randomisations by site<\/h3>\n
<\/p>\n
\n- Birmingham (University Hospitals Birmingham NHS Foundation Trust): 9<\/li>\n
- Cambridge (Cambridge University Hospitals NHS Foundation Trust): 23<\/li>\n
- Derby (University Hospitals of Derby & Burton NHS Foundation Trust): 15<\/li>\n
- Dorset (University Hospitals Dorset NHS Foundation Trust): 1<\/li>\n
- Ipswich (East Suffolk and North Essex NHS Foundation Trust): 11<\/li>\n
- Manchester (Manchester University NHS Foundation Trust): 25<\/li>\n
- Norwich (Norfolk & Norwich University Hospitals NHS Foundation Trust): 7<\/li>\n
- Portsmouth (Portsmouth Hospitals NHS Trust): 9<\/li>\n<\/ul>\n
[\/et_pb_accordion_item][et_pb_accordion_item _builder_version=”3.17.6″ title=”December 2020″]<\/p>\n
We are pleased to share a short update on the recruitment for the FLASH-UK study. We have now reached the halfway point with 82 randomisations achieved to date.<\/p>\n
Randomisations by site<\/h3>\n\n- Birmingham (University Hospitals Birmingham NHS Foundation Trust): 3<\/li>\n
- Cambridge (Cambridge University Hospitals NHS Foundation Trust): 17<\/li>\n
- Derby (University Hospitals of Derby & Burton NHS Foundation Trust): 14<\/li>\n
- Ipswich (East Suffolk and North Essex NHS Foundation Trust): 11<\/li>\n
- Manchester (Manchester University NHS Foundation Trust): 23<\/li>\n
- Norwich (Norfolk & Norwich University Hospitals NHS Foundation Trust): 6<\/li>\n
- Portsmouth (Portsmouth Hospitals NHS Trust): 8<\/li>\n<\/ul>\n
A huge thank you to all the participating sites for your contribution to this incredible milestone, especially with the extra difficulties during the COVID-19 pandemic.<\/p>\n
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[\/et_pb_text][et_pb_divider _builder_version=”3.17.6″]<\/p>\n
[\/et_pb_divider][et_pb_text admin_label=”Title:About the FreeStyle Libre device ” _builder_version=”3.17.6″]<\/p>\n
About the FreeStyle Libre 2 device<\/h2>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.0.47″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”About:left” _builder_version=”3.17.6″]<\/p>\n
FreeStyle Libre 2 is a glucose monitoring device in the form of a disc worn on the arm and a hand-held reader.<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”About:right” _builder_version=”3.17.6″]<\/p>\n
The device is designed to largely replace the recommended 4-10 painful finger-stick tests required each day for the self-management of type 1 diabetes. The FreeStyle Libre 2 has the additional function of optional alarms when glucose levels become low and high. Users can adjust these values within a permitted range so they are tailored to their type 1 diabetes management requirements.<\/p>\n
Compared to the currently available Freestyle Libre system, the FreeStyle Libre 2 has the additional function of optional alarms when glucose levels become low and high.<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.0.47″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Spacer” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_text][et_pb_divider _builder_version=”3.17.6″]<\/p>\n
[\/et_pb_divider][et_pb_text admin_label=”Title: Our team” _builder_version=”3.17.6″]<\/p>\n
Our team<\/h2>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.0.47″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”Team left” _builder_version=”3.17.6″]<\/p>\n
Read about our\u00a0research investigators<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”Team right” _builder_version=”3.17.6″]<\/p>\n
\n- Dr Lalantha Leelarathna – Chief Investigator (Manchester University NHS Foundation Trust)
View Dr Leelarathna\u2019s profile<\/a>.<\/li>\n- Dr Iain Cranston \u2013 Site Principal Investigator (Portsmouth Hospitals NHS Trust)
View Dr Cranston’s NHS profile<\/a>.<\/li>\n- Dr Mark Evans \u2013 Site Principal Investigator (Cambridge University Hospitals NHS Foundation Trust)
View Dr Evan’s MRL profile<\/a>.<\/li>\n- Dr Naresh Kanumilli \u2013 Co-Investigator & Community Diabetes Participant Referral Champion
View Dr Kanumilli’s practice website<\/a>.<\/li>\n- Dr Sarah Lumley \u2013 Site Principal Investigator (The Adam Practice, NHS England)
Visit Dr Lumley’s practice website<\/a>.<\/li>\n- Dr Parth Narendran \u2013 Site Principal Investigator (University Hospitals Birmingham NHS Foundation Trust
View Dr Narendran’s NHS profile<\/a>.<\/li>\n- Dr Sankalpa Neupane \u2013 Site Principal Investigator (Norfolk & Norwich University Hospitals NHS Foundation Trust)
Visit Dr Sankalpa’s diabetes centre website<\/a>.<\/li>\n- Professor Gerry Rayman \u2013 Site Principal Investigator (East Suffolk and North Essex NHS Foundation Trust)
View Professor Rayman’s NHS profile<\/a>.<\/li>\n- Dr Emma Wilmot \u2013 Site Principal Investigator (University Hospitals of Derby & Burton NHS Foundation Trust)
View Dr Wilmot’s NHS profile<\/a>.<\/li>\n- Dr Christopher Sutton- Lead Statistician (The University of Manchester)
View Dr Sutton\u2019s profile<\/a>.<\/li>\n- Professor Rachel Elliott – Lead Health Economist (The University of Manchester)
View Professor Elliott\u2019s profile<\/a>.<\/li>\n- Professor Katharine Barnard – Health Psychologist (Barnard Health)
View Professor Barnard\u2019s profile<\/a>.<\/li>\n- Matthew Burns \u2013 Lead Clinical Trial Manager for FLASH-UK (University of Manchester) based at the Manchester Clinical Trials Unit (CTU)
Visit the Manchester CTU website<\/a>.<\/li>\n<\/ul>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Spacer” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_text][et_pb_image admin_label=”Image: senior man with glucometer checking blood sugar level at home” src=”https:\/\/sites.manchester.ac.uk\/flash\/wp-content\/uploads\/sites\/248\/2020\/06\/FSL-device-mid-page.jpg” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_text][et_pb_text admin_label=”Title: Information for participants” _builder_version=”3.17.6″]<\/p>\n
Information for participants<\/h2>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.0.47″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”Information for participants left” _builder_version=”3.17.6″]<\/p>\n
For anyone wanting to take part in our study.<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”Information for participants right” _builder_version=”3.17.6″]<\/p>\n
Why is good control of blood sugar levels important?<\/h3>\n
Good control of blood sugar is important because it is linked to:<\/p>\n
\n- Patients experiencing fewer episodes of low (hypoglycaemia) and high (hyperglycaemia) blood sugar levels leading to fewer complications such as heart disease, kidney failure, and nerve damage.<\/li>\n
- Reducing the number of hospital appointments.<\/li>\n
- Giving patients an overall improved quality of life.<\/li>\n<\/ul>\n
About flash glucose monitoring<\/h3>\n
A flash glucose monitor is a small sensor that you wear just under your skin. It records your sugar levels continuously throughout the day and night. You can find out your blood sugar levels by scanning the sensor using a separate reader.<\/p>\n
Flash monitoring is less invasive than finger prick tests and can identify trends in your sugar levels to give you more confidence in your diabetes management. Read more about flash glucose monitoring on the Diabetes UK website<\/a>.<\/p>\nWhy the study is being conducted<\/h3>\n
We are investigating whether the FreeStyle Libre 2 device improves blood sugar control compared to finger-prick testing in type 1 diabetics. Evidence is required to guide future policy development on how the device could be used across NHS trusts. Without the evidence base, there is caution around providing this device to a wider group of type 1 diabetes patients. Our aim is to provide sufficient evidence to enable people with diabetes to benefit from the Freestyle Libre 2 device.<\/p>\n
How the FreeStyle Libre 2 device works<\/h3>\n
The sensor probe (0.4mm wide and 5mm in length) is inserted into the skin. The sensor is applied to the back of the upper arm with a disposable applicator. The hand-held reader can scan through clothing and displays blood sugar level readings on the screen.<\/p>\n
Taking part<\/h3>\n
Recruitment for FLASH-UK is currently closed to new participants.<\/p>\n
To learn more about participating in the study in the future, read our advert for participants<\/u><\/a>\u00a0(PDF) and our study participant information sheet<\/u><\/a>\u00a0(PDF).<\/p>\n <\/p>\n
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[\/et_pb_text][et_pb_image admin_label=”Image: Research clinic online consultation” src=”https:\/\/sites.manchester.ac.uk\/flash\/wp-content\/uploads\/sites\/248\/2020\/06\/Information-for-participants.jpg” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_text][et_pb_text admin_label=”Title: Information for participating sites ” _builder_version=”3.17.6″]<\/p>\n
Information for participating sites<\/h2>\n
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For hospitals involved in our study<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”Text: Covid-19 statement introduction” _builder_version=”3.17.6″]<\/p>\n
Recruitment for the FLASH-UK study is currently closed.<\/p>\n
[\/et_pb_text][et_pb_accordion admin_label=”Information for sites:Right” _builder_version=”3.17.6″][et_pb_accordion_item title=”Full FLASH-UK Statement on COVID-19 (October 2020)” open=”on” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n
Given the uncertainties around ongoing COVID-19 transmission and the impact this may have on access to services among those with diabetes, an approved virtual participant pathway has been integrated into the trial design.<\/p>\n
All six original sites and one additional site are open to recruitment, with the second additional site opening to recruitment shortly.<\/p>\n
Participants will be able to take part in the trial in a way they feel safest to do so. Participating sites will be able to offer flexibility and continued follow-up support to participants should in-clinic visits be disrupted by the COVID-19 pandemic.<\/p>\n
[\/et_pb_accordion_item][et_pb_accordion_item title=”Previous COVID-19 statements ” open=”on” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n
July 2020<\/h2>\n
Towards the end of the inaugural annual performance review period, the COVID-19 pandemic took hold in the UK. This has had an impact on non-COVID-19 research and development across all NHS trusts. Given the risk profile of FLASH-UK and advisory notices released from participating sites and the sponsor\u2019s trust, the Chief Investigator in discussion with Site-PIs and with the information to hand, took the decision to pause FLASH-UK to new recruits until further notice. The same was conveyed to sponsor and to the funder in the second Technical Steering Committee session which convened on the 19 March 2020.<\/p>\n
FLASH-UK has not submitted a formal notification to halt the trial from a regulatory perspective, as the trial will aim to progress current participants by means of remote assessment or through standard of care practices that are deemed acceptable to individual trusts during the COVID-19 response. The Chief Investigator and Site Principal Investigators will review the recruitment pause on a monthly basis. A trial amendment has been approved by REC \/ HRA for the addition of the two new sites. These have undergone preliminary site feasibility assessment and have been confirmed as potential recruitment sites. We believe the two additional sites will place the trial in an advantageous position to ensure new site initiation and activation, can commence soonest in a post-COVID-19 transitional setting.<\/p>\n
[\/et_pb_accordion_item][\/et_pb_accordion][et_pb_text admin_label=”Sites heading” _builder_version=”3.17.6″]<\/p>\n
Hospitals participating in our study<\/h3>\n
[\/et_pb_text][et_pb_accordion admin_label=”Information for sites:Right” _builder_version=”3.17.6″][et_pb_accordion_item title=”Open sites” open=”on” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n
Manchester
\n<\/strong>Manchester University NHS Foundation Trust<\/strong>
\nDate site opened:<\/strong> 20 December 2019
\nStatus:<\/strong> Recruitment and cohort follow-up complete.<\/p>\nDerby
\n<\/strong>University Hospitals of Derby & Burton NHS Foundation Trust<\/strong>
\nDate site opened: <\/strong>20 December 2019
\nStatus: <\/strong>Recruitment and cohort follow-up complete.<\/p>\nPortsmouth
\n<\/strong>Portsmouth Hospitals NHS Trust<\/strong>
\nDate site opened:<\/strong> 6 February 2020.
\nStatus:<\/strong> Recruitment and cohort follow-up complete.<\/p>\nCambridge<\/strong>
\nCambridge University Hospitals NHS Foundation Trust<\/strong>
\nDate site opened:<\/strong> 27 February 2020.
\nStatus:<\/strong> Recruitment and cohort follow-up complete.
\nNorwich<\/strong>
\nNorfolk and Norwich University Hospitals NHS Foundation Trust<\/strong>
\nDate site opened:<\/strong> 5 March 2020.
\nStatus:<\/strong> Recruitment and cohort follow-up complete.<\/p>\nBirmingham<\/strong>
\nUniversity Hospitals Birmingham NHS Foundation Trust<\/strong>
\nDate site opened:<\/strong> 3 March 2020.
\nStatus:<\/strong> Recruitment and cohort follow-up complete.<\/p>\nIpswich<\/strong>
\nEast Suffolk and North Essex NHS Foundation Trust<\/strong>
\nPrincipal Investigator:<\/strong> Professor Gerry Rayman Initiation ongoing.
\nDate site opened:<\/strong> 11 September 2020
\nStatus: <\/strong> Recruitment and cohort follow-up complete. <\/p>\nDorset<\/strong>
\nThe Adam Practice – NHS England<\/strong>
\nPrincipal Investigator:<\/strong> Dr Sarah Lumley
\nDate site opened:<\/strong> 4 November 2020
\nStatus: <\/strong> Recruitment and cohort follow-up complete.<\/p>\n[\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.17.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Spacer” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_divider][et_pb_text admin_label=”Title: Contact us” _builder_version=”3.17.6″]<\/p>\n
Contact us<\/h2>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.17.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”Contact: Left” _builder_version=”3.17.6″]<\/p>\n
Get in touch if you have any questions<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”Contact:Right” _builder_version=”3.17.6″]<\/p>\n
Email: Flash-UK@mft.nhs.uk<\/a>
Tel: 0161 276 6706<\/a>\u00a0or\u00a007792 063157<\/a>
(between 9am-4pm) and ask to speak to a member of the FLASH-UK study team.<\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.17.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Spacer” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=”1″ admin_label=”Connect Title” custom_padding=”0px||0px|” _builder_version=”3.0.90″ background_color=”#1d1d1d” module_class=”footer-section” prev_background_color=”#ffffff” global_module=”380″][et_pb_row admin_label=”row” global_parent=”380″ locked=”off” allow_player_pause=”off” parallax=”off” parallax_method=”on” parallax_1=”off” parallax_method_1=”off” parallax_2=”off” parallax_method_2=”off” parallax_3=”off” parallax_method_3=”off” make_fullwidth=”off” use_custom_width=”off” width_unit=”on” use_custom_gutter=”off” make_equal=”off” module_id=”footer-row” _builder_version=”3.0.89″][et_pb_column type=”1_3″][et_pb_text admin_label=”Contact Us Title” global_parent=”380″ background_layout=”dark” text_text_color=”#ffffff” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n
Contact Us<\/h4>\n
[\/et_pb_text][et_pb_text admin_label=”Contact Us” global_parent=”380″ text_text_color=”#aaaaaa” parent_locked=”off” background_layout=”light” text_orientation=”left” use_border_color=”off” border_color=”#ffffff” border_style=”solid” module_class=”contact-us” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n
+44 (0) 161 306 6000<\/p>\n
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Find Us<\/h4>\n
[\/et_pb_text][et_pb_text admin_label=”Address” global_parent=”380″ background_layout=”dark” text_orientation=”left” use_border_color=”off” border_color=”#ffffff” border_style=”solid” module_id=”address” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n
The University of Manchester
Oxford Rd
Manchester
M13 9PL
UK<\/a><\/p>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″][et_pb_text admin_label=”Connect Title” global_parent=”380″ background_layout=”dark” text_text_color=”#ffffff” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n
Connect With Us<\/h4>\n
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Recruitment for FLASH-UK is currently closed. This study will determine whether glucose monitoring with the FreeStyle Libre 2 device improves blood sugar levels compared to finger prick testing in type 1 diabetes. Project background FLASH-UK is the first UK-based clinical trial to study the effectiveness of the FreeStyle Libre 2 device. We will […]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_exactmetrics_skip_tracking":false,"footnotes":""},"class_list":["post-1423","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/pages\/1423","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/comments?post=1423"}],"version-history":[{"count":145,"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/pages\/1423\/revisions"}],"predecessor-version":[{"id":1623,"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/pages\/1423\/revisions\/1623"}],"wp:attachment":[{"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/media?parent=1423"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
We would like to express our utmost appreciation to sites for all of their hard work. This has enabled us to hit our recruitment target, especially when faced with the unprecedented COVID period.<\/p>\n
We look forward to working with sites on the follow-up and retention of all participants.<\/p>\n
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The FLASH-UK study has reached a milestone of 100 participants, with 49 randomisations in the Flash Blood Glucose Monitoring with Freestyle Libre group and 51 in the self-monitoring group.<\/p>\n
Randomisations by site<\/h3>\n
<\/p>\n
- \n
- Birmingham (University Hospitals Birmingham NHS Foundation Trust): 9<\/li>\n
- Cambridge (Cambridge University Hospitals NHS Foundation Trust): 23<\/li>\n
- Derby (University Hospitals of Derby & Burton NHS Foundation Trust): 15<\/li>\n
- Dorset (University Hospitals Dorset NHS Foundation Trust): 1<\/li>\n
- Ipswich (East Suffolk and North Essex NHS Foundation Trust): 11<\/li>\n
- Manchester (Manchester University NHS Foundation Trust): 25<\/li>\n
- Norwich (Norfolk & Norwich University Hospitals NHS Foundation Trust): 7<\/li>\n
- Portsmouth (Portsmouth Hospitals NHS Trust): 9<\/li>\n<\/ul>\n
[\/et_pb_accordion_item][et_pb_accordion_item _builder_version=”3.17.6″ title=”December 2020″]<\/p>\n
We are pleased to share a short update on the recruitment for the FLASH-UK study. We have now reached the halfway point with 82 randomisations achieved to date.<\/p>\n
Randomisations by site<\/h3>\n
- \n
- Birmingham (University Hospitals Birmingham NHS Foundation Trust): 3<\/li>\n
- Cambridge (Cambridge University Hospitals NHS Foundation Trust): 17<\/li>\n
- Derby (University Hospitals of Derby & Burton NHS Foundation Trust): 14<\/li>\n
- Ipswich (East Suffolk and North Essex NHS Foundation Trust): 11<\/li>\n
- Manchester (Manchester University NHS Foundation Trust): 23<\/li>\n
- Norwich (Norfolk & Norwich University Hospitals NHS Foundation Trust): 6<\/li>\n
- Portsmouth (Portsmouth Hospitals NHS Trust): 8<\/li>\n<\/ul>\n
A huge thank you to all the participating sites for your contribution to this incredible milestone, especially with the extra difficulties during the COVID-19 pandemic.<\/p>\n
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[\/et_pb_text][et_pb_divider _builder_version=”3.17.6″]<\/p>\n
[\/et_pb_divider][et_pb_text admin_label=”Title:About the FreeStyle Libre device ” _builder_version=”3.17.6″]<\/p>\n
About the FreeStyle Libre 2 device<\/h2>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.0.47″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”About:left” _builder_version=”3.17.6″]<\/p>\n
FreeStyle Libre 2 is a glucose monitoring device in the form of a disc worn on the arm and a hand-held reader.<\/p>\n
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The device is designed to largely replace the recommended 4-10 painful finger-stick tests required each day for the self-management of type 1 diabetes. The FreeStyle Libre 2 has the additional function of optional alarms when glucose levels become low and high. Users can adjust these values within a permitted range so they are tailored to their type 1 diabetes management requirements.<\/p>\n
Compared to the currently available Freestyle Libre system, the FreeStyle Libre 2 has the additional function of optional alarms when glucose levels become low and high.<\/p>\n
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[\/et_pb_divider][et_pb_text admin_label=”Title: Our team” _builder_version=”3.17.6″]<\/p>\n
Our team<\/h2>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.0.47″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”1_2″][et_pb_text admin_label=”Team left” _builder_version=”3.17.6″]<\/p>\n
Read about our\u00a0research investigators<\/p>\n
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- \n
- Dr Lalantha Leelarathna – Chief Investigator (Manchester University NHS Foundation Trust)
View Dr Leelarathna\u2019s profile<\/a>.<\/li>\n- Dr Iain Cranston \u2013 Site Principal Investigator (Portsmouth Hospitals NHS Trust)
View Dr Cranston’s NHS profile<\/a>.<\/li>\n- Dr Mark Evans \u2013 Site Principal Investigator (Cambridge University Hospitals NHS Foundation Trust)
View Dr Evan’s MRL profile<\/a>.<\/li>\n- Dr Naresh Kanumilli \u2013 Co-Investigator & Community Diabetes Participant Referral Champion
View Dr Kanumilli’s practice website<\/a>.<\/li>\n- Dr Sarah Lumley \u2013 Site Principal Investigator (The Adam Practice, NHS England)
Visit Dr Lumley’s practice website<\/a>.<\/li>\n- Dr Parth Narendran \u2013 Site Principal Investigator (University Hospitals Birmingham NHS Foundation Trust
View Dr Narendran’s NHS profile<\/a>.<\/li>\n- Dr Sankalpa Neupane \u2013 Site Principal Investigator (Norfolk & Norwich University Hospitals NHS Foundation Trust)
Visit Dr Sankalpa’s diabetes centre website<\/a>.<\/li>\n- Professor Gerry Rayman \u2013 Site Principal Investigator (East Suffolk and North Essex NHS Foundation Trust)
View Professor Rayman’s NHS profile<\/a>.<\/li>\n- Dr Emma Wilmot \u2013 Site Principal Investigator (University Hospitals of Derby & Burton NHS Foundation Trust)
View Dr Wilmot’s NHS profile<\/a>.<\/li>\n- Dr Christopher Sutton- Lead Statistician (The University of Manchester)
View Dr Sutton\u2019s profile<\/a>.<\/li>\n- Professor Rachel Elliott – Lead Health Economist (The University of Manchester)
View Professor Elliott\u2019s profile<\/a>.<\/li>\n- Professor Katharine Barnard – Health Psychologist (Barnard Health)
View Professor Barnard\u2019s profile<\/a>.<\/li>\n- Matthew Burns \u2013 Lead Clinical Trial Manager for FLASH-UK (University of Manchester) based at the Manchester Clinical Trials Unit (CTU)
Visit the Manchester CTU website<\/a>.<\/li>\n<\/ul>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.0.48″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Spacer” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_text][et_pb_image admin_label=”Image: senior man with glucometer checking blood sugar level at home” src=”https:\/\/sites.manchester.ac.uk\/flash\/wp-content\/uploads\/sites\/248\/2020\/06\/FSL-device-mid-page.jpg” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_text][et_pb_text admin_label=”Title: Information for participants” _builder_version=”3.17.6″]<\/p>\n
Information for participants<\/h2>\n
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For anyone wanting to take part in our study.<\/p>\n
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Why is good control of blood sugar levels important?<\/h3>\n
Good control of blood sugar is important because it is linked to:<\/p>\n
- \n
- Patients experiencing fewer episodes of low (hypoglycaemia) and high (hyperglycaemia) blood sugar levels leading to fewer complications such as heart disease, kidney failure, and nerve damage.<\/li>\n
- Reducing the number of hospital appointments.<\/li>\n
- Giving patients an overall improved quality of life.<\/li>\n<\/ul>\n
About flash glucose monitoring<\/h3>\n
A flash glucose monitor is a small sensor that you wear just under your skin. It records your sugar levels continuously throughout the day and night. You can find out your blood sugar levels by scanning the sensor using a separate reader.<\/p>\n
Flash monitoring is less invasive than finger prick tests and can identify trends in your sugar levels to give you more confidence in your diabetes management. Read more about flash glucose monitoring on the Diabetes UK website<\/a>.<\/p>\n
Why the study is being conducted<\/h3>\n
We are investigating whether the FreeStyle Libre 2 device improves blood sugar control compared to finger-prick testing in type 1 diabetics. Evidence is required to guide future policy development on how the device could be used across NHS trusts. Without the evidence base, there is caution around providing this device to a wider group of type 1 diabetes patients. Our aim is to provide sufficient evidence to enable people with diabetes to benefit from the Freestyle Libre 2 device.<\/p>\n
How the FreeStyle Libre 2 device works<\/h3>\n
The sensor probe (0.4mm wide and 5mm in length) is inserted into the skin. The sensor is applied to the back of the upper arm with a disposable applicator. The hand-held reader can scan through clothing and displays blood sugar level readings on the screen.<\/p>\n
Taking part<\/h3>\n
Recruitment for FLASH-UK is currently closed to new participants.<\/p>\n
To learn more about participating in the study in the future, read our advert for participants<\/u><\/a>\u00a0(PDF) and our study participant information sheet<\/u><\/a>\u00a0(PDF).<\/p>\n
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[\/et_pb_text][et_pb_image admin_label=”Image: Research clinic online consultation” src=”https:\/\/sites.manchester.ac.uk\/flash\/wp-content\/uploads\/sites\/248\/2020\/06\/Information-for-participants.jpg” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_text][et_pb_text admin_label=”Title: Information for participating sites ” _builder_version=”3.17.6″]<\/p>\n
Information for participating sites<\/h2>\n
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For hospitals involved in our study<\/p>\n
[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″][et_pb_text admin_label=”Text: Covid-19 statement introduction” _builder_version=”3.17.6″]<\/p>\n
Recruitment for the FLASH-UK study is currently closed.<\/p>\n
[\/et_pb_text][et_pb_accordion admin_label=”Information for sites:Right” _builder_version=”3.17.6″][et_pb_accordion_item title=”Full FLASH-UK Statement on COVID-19 (October 2020)” open=”on” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n
Given the uncertainties around ongoing COVID-19 transmission and the impact this may have on access to services among those with diabetes, an approved virtual participant pathway has been integrated into the trial design.<\/p>\n
All six original sites and one additional site are open to recruitment, with the second additional site opening to recruitment shortly.<\/p>\n
Participants will be able to take part in the trial in a way they feel safest to do so. Participating sites will be able to offer flexibility and continued follow-up support to participants should in-clinic visits be disrupted by the COVID-19 pandemic.<\/p>\n
[\/et_pb_accordion_item][et_pb_accordion_item title=”Previous COVID-19 statements ” open=”on” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n
July 2020<\/h2>\n
Towards the end of the inaugural annual performance review period, the COVID-19 pandemic took hold in the UK. This has had an impact on non-COVID-19 research and development across all NHS trusts. Given the risk profile of FLASH-UK and advisory notices released from participating sites and the sponsor\u2019s trust, the Chief Investigator in discussion with Site-PIs and with the information to hand, took the decision to pause FLASH-UK to new recruits until further notice. The same was conveyed to sponsor and to the funder in the second Technical Steering Committee session which convened on the 19 March 2020.<\/p>\n
FLASH-UK has not submitted a formal notification to halt the trial from a regulatory perspective, as the trial will aim to progress current participants by means of remote assessment or through standard of care practices that are deemed acceptable to individual trusts during the COVID-19 response. The Chief Investigator and Site Principal Investigators will review the recruitment pause on a monthly basis. A trial amendment has been approved by REC \/ HRA for the addition of the two new sites. These have undergone preliminary site feasibility assessment and have been confirmed as potential recruitment sites. We believe the two additional sites will place the trial in an advantageous position to ensure new site initiation and activation, can commence soonest in a post-COVID-19 transitional setting.<\/p>\n
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Hospitals participating in our study<\/h3>\n
[\/et_pb_text][et_pb_accordion admin_label=”Information for sites:Right” _builder_version=”3.17.6″][et_pb_accordion_item title=”Open sites” open=”on” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n
Manchester
\n<\/strong>Manchester University NHS Foundation Trust<\/strong>
\nDate site opened:<\/strong> 20 December 2019
\nStatus:<\/strong> Recruitment and cohort follow-up complete.<\/p>\nDerby
\n<\/strong>University Hospitals of Derby & Burton NHS Foundation Trust<\/strong>
\nDate site opened: <\/strong>20 December 2019
\nStatus: <\/strong>Recruitment and cohort follow-up complete.<\/p>\nPortsmouth
\n<\/strong>Portsmouth Hospitals NHS Trust<\/strong>
\nDate site opened:<\/strong> 6 February 2020.
\nStatus:<\/strong> Recruitment and cohort follow-up complete.<\/p>\nCambridge<\/strong>
\nCambridge University Hospitals NHS Foundation Trust<\/strong>
\nDate site opened:<\/strong> 27 February 2020.
\nStatus:<\/strong> Recruitment and cohort follow-up complete.
\nNorwich<\/strong>
\nNorfolk and Norwich University Hospitals NHS Foundation Trust<\/strong>
\nDate site opened:<\/strong> 5 March 2020.
\nStatus:<\/strong> Recruitment and cohort follow-up complete.<\/p>\nBirmingham<\/strong>
\nUniversity Hospitals Birmingham NHS Foundation Trust<\/strong>
\nDate site opened:<\/strong> 3 March 2020.
\nStatus:<\/strong> Recruitment and cohort follow-up complete.<\/p>\nIpswich<\/strong>
\nEast Suffolk and North Essex NHS Foundation Trust<\/strong>
\nPrincipal Investigator:<\/strong> Professor Gerry Rayman Initiation ongoing.
\nDate site opened:<\/strong> 11 September 2020
\nStatus: <\/strong> Recruitment and cohort follow-up complete. <\/p>\nDorset<\/strong>
\nThe Adam Practice – NHS England<\/strong>
\nPrincipal Investigator:<\/strong> Dr Sarah Lumley
\nDate site opened:<\/strong> 4 November 2020
\nStatus: <\/strong> Recruitment and cohort follow-up complete.<\/p>\n[\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.17.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Spacer” _builder_version=”3.17.6″]<\/p>\n
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Contact us<\/h2>\n
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Get in touch if you have any questions<\/p>\n
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Email: Flash-UK@mft.nhs.uk<\/a>
Tel: 0161 276 6706<\/a>\u00a0or\u00a007792 063157<\/a>
(between 9am-4pm) and ask to speak to a member of the FLASH-UK study team.<\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”row” parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” _builder_version=”3.17.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″][et_pb_text admin_label=”Spacer” _builder_version=”3.17.6″]<\/p>\n
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[\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=”1″ admin_label=”Connect Title” custom_padding=”0px||0px|” _builder_version=”3.0.90″ background_color=”#1d1d1d” module_class=”footer-section” prev_background_color=”#ffffff” global_module=”380″][et_pb_row admin_label=”row” global_parent=”380″ locked=”off” allow_player_pause=”off” parallax=”off” parallax_method=”on” parallax_1=”off” parallax_method_1=”off” parallax_2=”off” parallax_method_2=”off” parallax_3=”off” parallax_method_3=”off” make_fullwidth=”off” use_custom_width=”off” width_unit=”on” use_custom_gutter=”off” make_equal=”off” module_id=”footer-row” _builder_version=”3.0.89″][et_pb_column type=”1_3″][et_pb_text admin_label=”Contact Us Title” global_parent=”380″ background_layout=”dark” text_text_color=”#ffffff” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n
Contact Us<\/h4>\n
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+44 (0) 161 306 6000<\/p>\n
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Find Us<\/h4>\n
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The University of Manchester
Oxford Rd
Manchester
M13 9PL
UK<\/a><\/p>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″][et_pb_text admin_label=”Connect Title” global_parent=”380″ background_layout=”dark” text_text_color=”#ffffff” parent_locked=”off” background_position=”top_left” background_repeat=”repeat” background_size=”initial”]<\/p>\n
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Recruitment for FLASH-UK is currently closed. This study will determine whether glucose monitoring with the FreeStyle Libre 2 device improves blood sugar levels compared to finger prick testing in type 1 diabetes. Project background FLASH-UK is the first UK-based clinical trial to study the effectiveness of the FreeStyle Libre 2 device. We will […]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_exactmetrics_skip_tracking":false,"footnotes":""},"class_list":["post-1423","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/pages\/1423","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/comments?post=1423"}],"version-history":[{"count":145,"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/pages\/1423\/revisions"}],"predecessor-version":[{"id":1623,"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/pages\/1423\/revisions\/1623"}],"wp:attachment":[{"href":"https:\/\/sites.manchester.ac.uk\/flash\/wp-json\/wp\/v2\/media?parent=1423"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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- Dr Iain Cranston \u2013 Site Principal Investigator (Portsmouth Hospitals NHS Trust)
- Dr Lalantha Leelarathna – Chief Investigator (Manchester University NHS Foundation Trust)