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Hypo‐METRICS: Hypoglycaemia—MEasurement, ThResholds and ImpaCtS—A multi‐country clinical study to define the optimal threshold and duration of sensor‐detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: The study protocol

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cam.issuedOnline2022-06-22
dc.contributor.authorDivilly, Patrick
dc.contributor.authorZaremba, Natalie
dc.contributor.authorMahmoudi, Zeinab
dc.contributor.authorSøholm, Uffe
dc.contributor.authorPollard, Daniel J
dc.contributor.authorBroadley, Melanie
dc.contributor.authorAbbink, Evertine J
dc.contributor.authorde Galan, Bastiaan
dc.contributor.authorPedersen‐Bjergaard, Ulrik
dc.contributor.authorRenard, Eric
dc.contributor.authorEvans, Mark
dc.contributor.authorSpeight, Jane
dc.contributor.authorBrennan, Alan
dc.contributor.authorMcCrimmon, Rory J
dc.contributor.authorMüllenborn, Matthias
dc.contributor.authorHeller, Simon
dc.contributor.authorSeibold, Alexander
dc.contributor.authorMader, Julia K
dc.contributor.authorAmiel, Stephanie A
dc.contributor.authorPouwer, Frans
dc.contributor.authorChoudhary, Pratik
dc.contributor.orcidDivilly, Patrick [0000-0001-6916-3164]
dc.contributor.orcidZaremba, Natalie [0000-0002-1720-1621]
dc.contributor.orcidMahmoudi, Zeinab [0000-0001-9426-1962]
dc.contributor.orcidSøholm, Uffe [0000-0003-0848-9421]
dc.contributor.orcidPollard, Daniel J [0000-0001-5630-0115]
dc.contributor.orcidBroadley, Melanie [0000-0003-4408-6304]
dc.contributor.orcidde Galan, Bastiaan [0000-0002-1255-7741]
dc.contributor.orcidPedersen‐Bjergaard, Ulrik [0000-0003-0588-4880]
dc.contributor.orcidEvans, Mark [0000-0001-8122-8987]
dc.contributor.orcidSpeight, Jane [0000-0002-1204-6896]
dc.contributor.orcidBrennan, Alan [0000-0002-1025-312X]
dc.contributor.orcidMcCrimmon, Rory J [0000-0002-3957-1981]
dc.contributor.orcidMüllenborn, Matthias [0000-0003-3947-4695]
dc.contributor.orcidHeller, Simon [0000-0002-2425-9565]
dc.contributor.orcidSeibold, Alexander [0000-0002-2008-4593]
dc.contributor.orcidMader, Julia K [0000-0001-7854-4233]
dc.contributor.orcidAmiel, Stephanie A [0000-0003-2686-5531]
dc.contributor.orcidPouwer, Frans [0000-0002-8172-9818]
dc.contributor.orcidChoudhary, Pratik [0000-0001-7635-4735]
dc.date.accessioned2022-06-29T19:43:55Z
dc.date.available2022-06-29T19:43:55Z
dc.date.issued2022-09
dc.date.submitted2021-12-06
dc.date.updated2022-06-29T19:43:54Z
dc.descriptionFunder: Abbott Diabetes Care; Id: http://dx.doi.org/10.13039/100011946
dc.descriptionFunder: Innovative Medicines Initiative; Id: http://dx.doi.org/10.13039/501100010767
dc.description.abstract<jats:title>Abstract</jats:title><jats:sec><jats:title>Introduction</jats:title><jats:p>Hypoglycaemia is a significant burden to people living with diabetes and an impediment to achieving optimal glycaemic outcomes. The use of continuous glucose monitoring (CGM) has improved the capacity to assess duration and level of hypoglycaemia. The personal impact of sensor‐detected hypoglycaemia (SDH) is unclear. Hypo‐METRICS is an observational study designed to define the threshold and duration of sensor glucose that provides the optimal sensitivity and specificity for events that people living with diabetes experience as hypoglycaemia.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We will recruit 600 participants: 350 with insulin‐treated type 2 diabetes, 200 with type 1 diabetes and awareness of hypoglycaemia and 50 with type 1 diabetes and impaired awareness of hypoglycaemia who have recent experience of hypoglycaemia. Participants will wear a blinded CGM device and an actigraphy monitor to differentiate awake and sleep times for 10 weeks. Participants will be asked to complete three short surveys each day using a bespoke mobile phone app, a technique known as ecological momentary assessment. Participants will also record all episodes of self‐detected hypoglycaemia on the mobile app. We will use particle Markov chain Monte Carlo optimization to identify the optimal threshold and duration of SDH that have optimum sensitivity and specificity for detecting patient‐reported hypoglycaemia. Key secondary objectives include measuring the impact of symptomatic and asymptomatic SDH on daily functioning and health economic outcomes.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The protocol was approved by local ethical boards in all participating centres. Study results will be shared with participants, in peer‐reviewed journal publications and conference presentations.</jats:p></jats:sec>
dc.identifier.doi10.17863/CAM.85878
dc.identifier.eissn1464-5491
dc.identifier.issn0742-3071
dc.identifier.otherdme14892
dc.identifier.otherdme-2021-00965.r1
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/338465
dc.languageen
dc.language.isoeng
dc.publisherWiley
dc.publisher.urlhttp://dx.doi.org/10.1111/dme.14892
dc.subjectSTUDY PROTOCOLS
dc.subjectcontinuous glucose monitoring
dc.subjecthypoglycaemia
dc.subjectpatient‐reported hypoglycaemia
dc.subjectquality of life
dc.subjectsensor‐detected
dc.titleHypo‐METRICS: Hypoglycaemia—MEasurement, ThResholds and ImpaCtS—A multi‐country clinical study to define the optimal threshold and duration of sensor‐detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: The study protocol
dc.typeArticle
dcterms.dateAccepted2022-05-26
prism.publicationNameDiabetic Medicine
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1111/dme.14892

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