Department of Applied Pharmaceutical Sciences and Clinical Pharmacy, Faculty of Pharmacy, Isra University, Amman, Jordan.
School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, United Kingdom.
Res Social Adm Pharm. 2023 Feb;19(2):322-331. doi: 10.1016/j.sapharm.2022.09.017. Epub 2022 Oct 12.
A 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.
A 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.
A 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.
The SUGAR intervention can prevent hypoglycaemia without increasing the risk of fasting hyperglycaemia warranting therapy adjustment in elderly Jordanians with T2DM.
在约旦，针对 2 型糖尿病（T2DM）老年患者，药剂师主导的个体化教育干预（SUGAR）方案旨在预防低血糖。
评估 SUGAR 干预措施联合常规护理与单纯常规护理相比，在预防约旦 T2DM 老年患者低血糖发作方面的效果。
在约旦一家医院的门诊进行了一项单中心、实用、开放标签、随机对照试验，并嵌入了过程评估。招募了年龄≥65 岁、服用磺脲类药物、胰岛素或至少三种抗糖尿病药物的 T2DM 老年患者，并将他们平行随机分为 SUGAR 干预联合常规护理组或对照组（常规护理）。主要结局是随机分组后 3 个月内每位患者的总低血糖发作率。次要结局包括低血糖发作亚型的发生率、任何和各类型低血糖的发生率、低血糖无发作的生存概率以及需要治疗调整的空腹高血糖发生率。通过血糖仪和日记进行测量，在 3 个月时进行评估，并采用意向治疗进行分析。
共有 212 名参与者（平均年龄 68.98 岁，58.96%为男性）被随机分配（每组 106 名），其中 190 名（89.62%）参与者完成了研究。与对照组相比，干预组在 3 个月时总低血糖发作次数更少（3.91 [SD 7.65] vs. 6.87 [SD 11.99]；p<0.0001）。干预组在 3 个月时显著降低了任何、严重和有症状低血糖的发生亚型率、低血糖的发生率以及低血糖无发作的生存概率。与对照组相比，空腹高血糖需要治疗调整的发生率相似。
SUGAR 干预可预防低血糖，而不会增加需要调整治疗的空腹高血糖风险，适合约旦的 T2DM 老年患者。
