Effectiveness of the SUGAR intervention on hypoglycaemia in elderly patients with type 2 diabetes: A pragmatic randomised controlled trial |
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| Affiliation: | 1. Department of Applied Pharmaceutical Sciences and Clinical Pharmacy, Faculty of Pharmacy, Isra University, Amman, Jordan;2. School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, United Kingdom;3. Advanced Research Fellow NIHR ARC NWL, Department of Primary Care and Public Health, School of Public Health, Faculty of Medicine, Imperial College London, United Kingdom;1. Department of Sociology and Anthropology, University of Mississippi, United States;2. Department of Pharmacy Administration, University of Mississippi, United States;3. Department of Pharmacy Practice, University of Mississippi, United States;4. Department of Biology and Department of Chemistry, University of Mississippi, United States;5. University of Mississippi School of Pharmacy, Dept of Pharmacy Administration, United States;1. Ballarat Health Services, Victoria, Australia;2. Monash University, Victoria, Australia;3. Flinders Medical Centre, South Australia, Australia;1. Scholarship and Research, Department of PA Studies, Department of Epidemiology and Prevention, Wake Forest School of Medicine, USA;2. Department of Biostatistics and Data Science, Wake Forest School of Medicine, USA;3. Department of PA Studies, Wake Forest School of Medicine, USA;4. Pharmacy Practice and Chair, Division of Practice Advancement and Clinical Education, University of North Carolina, Eshelman School of Pharmacy, USA;5. J. Paul Sticht Center on Aging and Rehabilitation, Wake Forest Baptist Medical Center, USA;6. Perelman School of Medicine, University of Pennsylvania, USA;7. Gerontology and Geriatric Medicine, Wake Forest School of Medicine, USA;8. Clinical Education, Physician Assistant Studies Program, Seton Hill University, USA;9. Scholarship and Research, Department of PA Studies, Wake Forest School of Medicine, USA;1. Department of Orthopedics, The Affiliated Changzhou No.2 People''s Hospital of Nanjing Medical University, Changzhou, China;2. Department of Pharmacy, The Affiliated Changzhou No.2 People''s Hospital of Nanjing Medical University, Changzhou, China |
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| Abstract: | BackgroundA pharmacist-led, individualised, educational intervention (SUGAR) was formulated to prevent hypoglycaemia among elderly patients with type 2 diabetes mellitus (T2DM) in Jordan.Objective(s)To evaluate the effectiveness of the SUGAR intervention added to usual care compared with usual care only in preventing hypoglycaemic attacks in elderly patients with T2DM in Jordan.MethodsA single-centre, pragmatic, open-label, randomised controlled trial with embedded process evaluation was conducted at the outpatient clinics of a hospital in Jordan. Elderly patients (≥65 years) with T2DM and on sulfonylurea, insulin, or at least three anti-diabetic medications were recruited and parallelly randomised to the SUGAR intervention with usual care or the control (usual care) groups. The primary outcome was the rate of total hypoglycaemic attacks per patient after 3 months from randomisation. Secondary outcomes included rate of hypoglycaemia subtypes, the incidence of any and subtypes of hypoglycaemia, hypoglycaemia-free survival probability, and incidence of fasting hyperglycaemia necessitating therapy modification. Outcomes were measured through glucose meters and diaries, assessed at 3 months, and analysed by intention to treat.ResultsA total of 212 participants (mean age 68.98 years, 58.96% men) were randomly allocated (106 in each group), with 190 (89.62%) participants completing the study. The mean of total hypoglycaemic attacks was less in the intervention group compared with the control group (3.91 [SD 7.65] vs. 6.87 [SD 11.99]; p < 0.0001) at three months. The intervention significantly reduced the rate of hypoglycaemia subtypes; the odds to experience any, severe, and symptomatic hypoglycaemia; and increased hypoglycaemia-free survival probability compared with the control group at three months. Incidence of fasting hyperglycaemia necessitating therapy modification was similar between groups.ConclusionsThe SUGAR intervention can prevent hypoglycaemia without increasing the risk of fasting hyperglycaemia warranting therapy adjustment in elderly Jordanians with T2DM. |
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| Keywords: | Education Older adults Type 2 diabetes Hypoglycemia Pharmacist |
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