Department of Family & Community Medicine, Scott & White Healthcare, College of Medicine, Texas A&M Health Science Center, Temple, TX, USA.
BMC Public Health. 2014 Jan 23;14:71. doi: 10.1186/1471-2458-14-71.
Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons.
We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model.
Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants' diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups.
Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control.
Clinicaltrials.gov Identifier: NCT01221090.
患者的糖尿病自我护理已被证明有助于减轻疾病严重程度和相关医疗费用。我们比较了两种不同的糖尿病自我护理干预措施在种族/族裔多样化人群中的血糖控制效果。我们还探讨了糖化血红蛋白 (HbA1c) 的降低是否在少数人群中更为显著。
我们对年龄≥ 18 岁且上次测量的 HbA1c≥7.5%（≥58mmol/mol）的 376 名 2 型糖尿病患者进行了一项开放性、随机对照试验。参与者被随机分为：1）慢性病自我管理计划（CDSMP；n = 101）；2）个人数字助理（PDA）上的糖尿病自我护理软件（n = 81）；3）干预措施联合（CDSMP + PDA；n = 99）；或 4）常规护理（对照组；n = 95）。招募于 2009 年 1 月至 2011 年 6 月在一所大学附属多专科实践的七个区域诊所进行。主要结局是从随机分组到 12 个月时 HbA1c 的变化。数据分析采用多层次统计模型。
CDSMP、PDA、CDSMP + PDA 和对照组的平均基线 HbA1c 分别为 9.4%、9.3%、9.2%和 9.2%。12 个月时各组的 HbA1c 降低平均为 1.1%、0.7%、1.1%和 0.7%，基于模型无显著差异（P =.771）。除了 PDA 组的参与者报告与对照组相比食用更多高脂肪食物（P <.004）外，参与者的糖尿病自我护理活动没有其他显著差异。探索性亚分析未发现少数人群 HbA1c 有明显降低，而是所有种族/族裔群体都有适度降低。
尽管行为和技术干预可以导致血糖控制的一些适度改善，但这些干预措施在实现血糖控制方面并不优于常规护理。需要进一步研究以了解这些干预措施如何在临床实践中最有效。我们对照组接受常规护理的 HbA1c 水平降低也表明，综合医疗体系中的良好常规护理可以导致更好的血糖控制。
Clinicaltrials.gov 标识符：NCT01221090。
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