A Randomized Trial of Alerting to Low Glycated Hemoglobin Level in Older Adults: Results of the Low Indexes of Metabolism Intervention Trial B (LIMIT-B) |
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| Affiliation: | 1. Clalit Health Services (CHS), Northern District, Israel;2. The Azrieli Faculty of Medicine in Galilee, Bar-Ilan University, Safed, Israel;3. International Group for Reducing Inappropriate Medication Use & Polypharmacy (IGRIMUP), Bat Yam, Israel;4. Department of Family Medicine, Sial Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel;5. Unit for Community Geriatrics, Division of Health in the Community, Ben-Gurion University of the Negev, Beer-Sheva, Israel;6. Department of Geriatrics, Soroka Medical Center, Beer-Sheva, Israel;1. Geriatric Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy;2. Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy;3. The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC;4. School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC;5. Schools of Social Work and Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC;1. Department of Pharmacy Practice, Albany College of Pharmacy & Health Sciences, Vermont Campus, Colchester, VT;2. Department of Family Medicine, UNC School of Medicine, Chapel Hill, NC;3. Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, Chapel Hill, NC;1. Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland;2. Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland;3. Mercer''s Institute for Research on Ageing, St James''s Hospital, Dublin, Ireland;1. Department of Neurology, Amsterdam UMC/University of Amsterdam, Amsterdam, the Netherlands;2. Department of General Practice, Amsterdam UMC/University of Amsterdam, Amsterdam, the Netherlands;3. Department of Neurology, Donders institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands;1. School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea;2. Department of Psychiatry, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Gyeonggi-do, South Korea;3. College of Pharmacy and Institute of Pharmaceutical Science and Technology, Hanyang University, Ansan, Gyeonggi-do, South Korea;4. Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia |
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| Abstract: | ObjectivesThe benefit of alerting clinical staff to low plasma glycated hemoglobin (HbA1c) in patients aged 75 years and older who receive antidiabetic drugs remains uncertain.Design, Setting, and ParticipantsIn a randomized controlled trial, 1684 patients with HbA1c ≤ 6.5% who received antidiabetic drugs were assigned to have an e-mail alert sent to their physician, and 1643 were assigned to have no such alert (control group). The primary outcome of the trial was annual death. Secondary outcomes included antidiabetic drug dose reduction and HbA1c change.ResultsIn the first quarter, antidiabetic drug-defined daily doses were reduced on average by 10.4 ± 35.8 (16% ± 55%) in the intervention group and by 6.4 ± 36.1 (10% ± 56%) in the control group (difference −4.1 ± 1.2, 95% confidence interval [CI] −6.5 to −1.6; P = .001). Measured HbA1c levels were raised by a mean (± standard deviation) of 0.28 ± 0.77 in the intervention group and by 0.18 ± 0.57 in the control group (difference 0.10 ± 0.02, 95% CI –0.15 to −0.059, P < .001). One year after the alerts, 121 patients (7.2%) died in the intervention group and 107 patients (6.5%) died in the control group (relative risk 1.1, 95% CI 0.86-1.42; P = .44).Conclusions and ImplicationsIn this trial, alerting clinical staff to low HbA1c in patients aged 75 years and older treated with antidiabetic medicines was associated with mildly reduced antidiabetic doses and increased HbA1c but was not associated with a significant difference in survival rate compared with usual clinical care. |
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| Keywords: | Aged aged 80 and older low HbA1c electronic mail iatrogenic disease randomized controlled trial |
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