Thanh Ho Thi Kim, Tien Tran Manh
Hanoi Medical University, Vietnam National Geriatric Hospital, 1 Ton That Tung Street, Dong Da, Hanoi, Vietnam.
Diabetes Ther. 2021 May;12(5):1503-1521. doi: 10.1007/s13300-021-01052-8. Epub 2021 Apr 11.
In low- to middle-income countries such as Vietnam, urgent measures are required to prevent and control type 2 diabetes and its complications. This study measured the effect of a 3-month patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control.
This was a single-center randomized controlled study among adult outpatients with type 2 diabetes. Patients were randomly assigned to 3-month community intervention consisting of group education for type 2 diabetes knowledge, diet, exercise in combination with usual diabetes care, or to usual diabetes care alone (control). Diabetes knowledge was measured with a modified Michigan University Diabetes Knowledge Test (MDKT). Other study outcomes included change in mean HbA1c, fasting blood glucose (FBG), and systolic blood pressure (SBP).
A total of 364 patients were randomized, 182 to the intervention group and 182 to control. The two groups were similar regarding main baseline characteristics. The male/female ratio was 45.1%/54.9% and mean age was 62.2 ± 9.3 years. Approximately half the patients (48.1%) were overweight and 15.7% were obese, mean baseline HbA1c was 8.21 ± 1.92%, and only 29.9% of participants had a baseline HbA1c < 7.0%. At baseline, diabetes knowledge was "very poor" or "poor" in 63.7% of patients. After a 3-month follow-up, the proportion achieving the target MDKT score increased from 37.4% to 81.3% in the intervention group and from 35.2% to 51.7% in the control (between-group difference P < 0.001). The estimate (SD) of the difference between intervention and control groups was - 1.63 (2.16), 95% CI - 2.07 to - 1.18. Mean changes from baseline HbA1c were - 0.54 ± 1.41% and - 0.18 ± 1.33% in the intervention and control groups, respectively (P = 0.012). Among those with poor glycemic control (HbA1c ≥ 7%) at baseline, mean changes at 3 months were - 0.80 ± 1.52% vs 0.41 ± 1.47%, respectively, (P = 0.013). Statistically significant decreases in FBG and SBP were also observed in the intervention group at 3 months, but not in the control group. Multivariate analysis revealed the variables with the strongest influence on blood glucose control at 3 months were study group, baseline MDKT score, diabetes duration, and baseline HbA1c (all P ≤ 0.05).
Provision of a structured educational program to Vietnamese people living with type 2 diabetes is effective at improving disease knowledge and is associated with better glycemic control. Larger and longer-term studies are now warranted to confirm these findings.
This trial was retrospectively registered on 27 May 2020 through the https://clinicaltrials.gov site with the following identifier: NCT04403841.
在越南等低收入和中等收入国家，需要采取紧急措施来预防和控制2型糖尿病及其并发症。本研究评估了在资源匮乏地区进行的为期3个月的患者教育和自我管理干预对糖尿病知识及血糖控制水平的影响。
这是一项针对成年2型糖尿病门诊患者的单中心随机对照研究。患者被随机分配至接受为期3个月的社区干预组，该干预包括2型糖尿病知识、饮食、运动的集体教育并结合常规糖尿病护理，或仅接受常规糖尿病护理（对照组）。采用改良的密歇根大学糖尿病知识测试（MDKT）来评估糖尿病知识。其他研究结局包括平均糖化血红蛋白（HbA1c）、空腹血糖（FBG）和收缩压（SBP）的变化。
共有364例患者被随机分组，182例进入干预组，182例进入对照组。两组在主要基线特征方面相似。男女比例为45.1%/54.9%，平均年龄为62.2±9.3岁。约一半患者（48.1%）超重，15.7%肥胖，基线平均HbA1c为8.21±1.92%，仅有29.9%的参与者基线HbA1c<7.0%。基线时，63.7%的患者糖尿病知识“非常差”或“差”。经过3个月的随访，干预组达到MDKT目标分数的比例从37.4%增至81.3%，对照组从35.2%增至51.7%（组间差异P<0.001）。干预组与对照组之间差异的估计值（标准差）为-1.63（2.16），95%置信区间为-2.07至-1.18。干预组和对照组HbA1c较基线的平均变化分别为-0.54±1.41%和-0.18±1.33%（P=0.012）。在基线时血糖控制不佳（HbA1c≥7%）的患者中，3个月时的平均变化分别为-0.80±1.52%和0.41±1.47%（P=0.013）。干预组在3个月时FBG和SBP也有统计学意义的下降，而对照组未出现。多变量分析显示，对3个月时血糖控制影响最显著的变量为研究组、基线MDKT分数、糖尿病病程和基线HbA1c（均P≤0.05）。
为越南2型糖尿病患者提供结构化教育项目可有效提高疾病知识，并与更好的血糖控制相关。现在需要开展更大规模和更长期的研究来证实这些发现。
本试验于2020年5月27日通过https://clinicaltrials.gov网站进行回顾性注册，标识符如下：NCT04403841。
