The effect of USM-IAM-based counselling vs standard counselling on insulin adherence, FBS and HbA1c among patients with uncontrolled Type 2 Diabetes Mellitus (T2DM): A randomised controlled trial.

The effect of USM-IAM-based counselling vs standard counselling on insulin adherence, FBS and HbA1c among patients with uncontrolled Type 2 Diabetes Mellitus (T2DM): A randomised controlled trial. | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The effect of USM-IAM-based counselling vs standard counselling on insulin adherence, FBS and HbA1c among patients with uncontrolled Type 2 Diabetes Mellitus (T2DM): A randomised controlled trial. Aida Maziha Zainudin, Aida Hanum Ghulam Rasool, Najib Majdi Yaacob, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3829330/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 17 Jul, 2024 Read the published version in BMC Endocrine Disorders → Version 1 posted 4 You are reading this latest preprint version Abstract Background: Many patients with T2DM on insulin are not optimally controlled despite receiving standard diabetes education counselling. Poor insulin adherence may be a contributing factor. We developed and evaluated a new module [USM-Insulin Adherence Module (USM-IAM)] on insulin-treated patients with poorly controlled diabetes. Methods: Eligibility criteria are those diagnosed with T2DM, aged between 18 and 65 years, with HbA1c between 8 -15% and on insulin therapy for one year. Patients were randomly allocated to receive either the USM-IAM-based counselling or the standard counselling at baseline and the second visit. Patients were instructed to adjust insulin doses based on blood glucose levels. Outcomes were changes in adherence score, FBS and HbA1c levels from baseline to three months and baseline to sixth month. Results: Ninety patients were randomised to each group. The baseline sociodemographic and clinical characteristics were homogenous among groups. Ninety patients were analysed for each group. Adherence score changes between baseline to three months were -8.30 (-11.47, -5.14) in UCG and -7.64 (-10.89, -4.40) in SCG, between baseline to sixth month were -10.21 (-13.40, -7.03) in UCG and -10.79 (-14.64, -6.97) in SCG. FBS changes between baseline to three months were 1.374 (0.25, 2.50) in UCG and 0.438 (-0.66, 1.54) in SCG, and between baseline to sixth month were 1.713 (0.473, 2.95) in UCG and 0.998 (-0.02, 2.01) in SCG. HbA1c changes between baseline to three months were 1.374 (0.25, 2.50) in UCG and 0.547 (0.12, 0.98) in SCG, and between baseline to sixth month were 1.03 (0.65, 1.41) in UCG and 0.617 (0.20, 1.03) in SCG. Conclusion: Both groups had significant improvements in adherence score and HbA1c with time, with higher improvement in patients receiving the USM-IAM-based counselling. FBS reductions were significant in the intervention group but not in the control group. Trial registration : This study protocol is registered with Clicaltrials.gov with ID NCT05125185 dated 17th November 2021. Insulin adherence insulin adherence module diabetes education type 2 diabetes mellitus diabetes Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 17 Jul, 2024 Read the published version in BMC Endocrine Disorders → Version 1 posted Editorial decision: Revision requested 04 Jan, 2024 Submission checks completed at journal 03 Jan, 2024 Editor assigned by journal 03 Jan, 2024 First submitted to journal 02 Jan, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3829330","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":265139711,"identity":"bfa555b2-27d0-49cd-9ac9-953e4467513a","order_by":0,"name":"Aida Maziha Zainudin","email":"","orcid":"","institution":"Universiti Sains Malaysia","correspondingAuthor":false,"prefix":"","firstName":"Aida","middleName":"Maziha","lastName":"Zainudin","suffix":""},{"id":265139712,"identity":"cb9507f9-3ac3-4026-bdac-4c54d1e04636","order_by":1,"name":"Aida Hanum Ghulam Rasool","email":"","orcid":"","institution":"Universiti Sains Malaysia","correspondingAuthor":false,"prefix":"","firstName":"Aida","middleName":"Hanum Ghulam","lastName":"Rasool","suffix":""},{"id":265139713,"identity":"62e5a468-8978-4bbf-b19a-f157ae1c9dd0","order_by":2,"name":"Najib Majdi Yaacob","email":"","orcid":"","institution":"Universiti Sains Malaysia","correspondingAuthor":false,"prefix":"","firstName":"Najib","middleName":"Majdi","lastName":"Yaacob","suffix":""},{"id":265139714,"identity":"c84cf577-55d0-4ac3-86b0-ce34d14e8284","order_by":3,"name":"Rosediani Muhammad","email":"","orcid":"","institution":"Universiti Sains Malaysia","correspondingAuthor":false,"prefix":"","firstName":"Rosediani","middleName":"","lastName":"Muhammad","suffix":""},{"id":265139715,"identity":"855a6a20-7bb4-41dd-ab1d-e0d1a6ffa06d","order_by":4,"name":"Wan Mohd Izani Wan Mohamed","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAkklEQVRIiWNgGAWjYBACNhCRUEG6ljMkW8XYRopqPv7Dzx48nHfYXreBO02CSIcdMzdI3HY4cdsB3m1EamFsMJMAakkwI14LM/s3icQ5h+1J0MLGA7Sl4TAjCQ7j4SmTSDiWDnQb72YLorTI9x/fJvmjxtre7HjvxhtEaUEAZgYW4hyGoukDyVpGwSgYBaNgRAAA7SYqQJv3+GEAAAAASUVORK5CYII=","orcid":"","institution":"Universiti Sains Malaysia","correspondingAuthor":true,"prefix":"","firstName":"Wan","middleName":"Mohd Izani Wan","lastName":"Mohamed","suffix":""}],"badges":[],"createdAt":"2024-01-02 11:14:06","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3829330/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3829330/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12902-024-01577-6","type":"published","date":"2024-07-18T00:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":60685106,"identity":"cad658de-9c9d-4924-acda-5984809ab811","added_by":"auto","created_at":"2024-07-19 13:31:05","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":515982,"visible":true,"origin":"","legend":"","description":"","filename":"2.USMIAMbasedcounselingoninsulinadherenceHbA1c.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3829330/v1_covered_cb255099-da8a-4d06-84b5-a17598eec955.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"The effect of USM-IAM-based counselling vs standard counselling on insulin adherence, FBS and HbA1c among patients with uncontrolled Type 2 Diabetes Mellitus (T2DM): A randomised controlled trial.","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-endocrine-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bend","sideBox":"Learn more about [BMC Endocrine Disorders](http://bmcendocrdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bend/default.aspx","title":"BMC Endocrine Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Insulin adherence, insulin adherence module, diabetes education, type 2 diabetes mellitus, diabetes","lastPublishedDoi":"10.21203/rs.3.rs-3829330/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3829330/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Many patients with T2DM on insulin are not optimally controlled despite receiving standard diabetes education counselling. Poor insulin adherence may be a contributing factor. We developed and evaluated a new module [USM-Insulin Adherence Module (USM-IAM)] on insulin-treated patients with poorly controlled diabetes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e Eligibility criteria are those diagnosed with T2DM, aged between 18 and 65 years, with HbA1c between 8 -15% and on insulin therapy for one year. Patients were randomly allocated to receive either the USM-IAM-based counselling or the standard counselling at baseline and the second visit. Patients were instructed to adjust insulin doses based on blood glucose levels. Outcomes were changes in adherence score, FBS and HbA1c levels from baseline to three months and baseline to sixth month.\u003c/p\u003e\n\u003cp\u003eResults: Ninety patients were randomised to each group. The baseline sociodemographic and clinical characteristics were homogenous among groups. Ninety patients were analysed for each group. Adherence score changes between baseline to three months were -8.30 (-11.47, -5.14) in UCG and -7.64 (-10.89, -4.40) in SCG, between baseline to sixth month were -10.21 (-13.40, -7.03) in UCG and -10.79 (-14.64, -6.97) in SCG. FBS changes between baseline to three months were 1.374 (0.25, 2.50) in UCG and 0.438 (-0.66, 1.54) in SCG, and between baseline to sixth month were 1.713 (0.473, 2.95) in UCG and 0.998 (-0.02, 2.01) in SCG. HbA1c changes between baseline to three months were 1.374 (0.25, 2.50) in UCG and 0.547 (0.12, 0.98) in SCG, and between baseline to sixth month were 1.03 (0.65, 1.41) in UCG and 0.617 (0.20, 1.03) in SCG.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e Both groups had significant improvements in adherence score and HbA1c with time, with higher improvement in patients receiving the USM-IAM-based counselling. 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