HbA1c 作为 2 型糖尿病的共同治疗目标？DEBATE 试验的二次分析。

HbA1c as a shared treatment goal in type 2 diabetes? A secondary analysis of the DEBATE trial.

机构信息

Institute of General Practice (ifam), Medical Faculty, Centre for Health & Society (chs), Heinrich Heine University Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.

Institute of General Practice and Primary Care, Chair of General Practice II and Patient Centredness in Primary Care, Faculty of Health/School of Medicine, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448, Witten, Germany.

出版信息

BMC Prim Care. 2023 May 13;24(1):115. doi: 10.1186/s12875-023-02067-9.

DOI:10.1186/s12875-023-02067-9

PMID:37173620

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10182591/

Abstract

BACKGROUND

Type 2 diabetes mellitus (T2DM) is a major health problem in the western world. Despite a widespread implementation of integrated care programs there are still patients with poorly controlled T2DM. Shared goal setting within the process of Shared Decision Making (SDM) may increase patient's compliance and adherence to treatment regimen. In our secondary analysis of the cluster-randomized controlled DEBATE trial, we investigated if patients with shared vs. non-shared HbA1c treatment goal, achieve their glycemic goals.

METHODS

In a German primary care setting, we collected data before intervention at baseline, 6, 12 and 24 months. Patients with T2DM with an HbA1c ≥ 8.0% (64 mmol/mol) at the time of recruitment and complete data at baseline and after 24 months were eligible for the presented analyses. Using a generalized estimating equation analysis, we analysed the association between the achievement of HbA1c goals at 24 months based on their shared vs. non-shared status, age, sex, education, partner status, controlled for baseline HbA1c and insulin therapy.

RESULTS

From N = 833 recruited patients at baseline, n = 547 (65.7%) from 105 General Practitioners (GPs) were analysed. 53.4% patients were male, 33.1% without a partner, 64.4% had a low educational level, mean age was 64.6 (SD 10.6), 60.7% took insulin at baseline, mean baseline HbA1c was 9.1 (SD 1.0). For 287 patients (52.5%), the GPs reported to use HbA1c as a shared goal, for 260 patients (47.5%) as a non-shared goal. 235 patients (43.0%) reached the HbA1c goal after two years, 312 patients (57.0%) missed it. Multivariable analysis shows that shared vs. non-shared HbA1c goal setting, age, sex, and education are not associated with the achievement of the HbA1c goal. However, patients living without a partner show a higher risk of missing the goal (p = .003; OR 1.89; 95% CI 1.25-2.86).

CONCLUSIONS

Shared goal setting with T2DM patients targeting on HbA1c-levels had no significant impact on goal achievement. It may be assumed, that shared goal setting on patient-related clinical outcomes within the process of SDM has not been fully captured yet.

TRIAL REGISTRATION

The trial was registered at ISRCTN registry under the reference ISRCTN70713571.

摘要

背景

2 型糖尿病（T2DM）是西方世界的一个主要健康问题。尽管广泛实施了综合护理计划，但仍有一些 T2DM 患者的病情控制不佳。在共同决策（SDM）过程中设定共同目标可能会提高患者对治疗方案的依从性和坚持性。在我们对 DEBATE 试验的聚类随机对照二次分析中，我们研究了设定 HbA1c 治疗目标的患者（共同目标设定与非共同目标设定）是否能够达到血糖目标。

方法

在德国初级保健环境中，我们在干预前的基线、6、12 和 24 个月收集数据。在招募时 HbA1c≥8.0%（64 mmol/mol）且基线和 24 个月时数据完整的 T2DM 患者有资格参加本次分析。使用广义估计方程分析，我们根据他们的共同设定或非共同设定状态、年龄、性别、教育程度、伴侣状况、基线 HbA1c 和胰岛素治疗情况，分析了 24 个月时 HbA1c 目标达成情况之间的关联。

结果

从基线时招募的 833 名患者中，有 105 名全科医生（GP）的 547 名（65.7%）患者进行了分析。53.4%的患者为男性，33.1%没有伴侣，64.4%的患者受教育程度较低，平均年龄为 64.6（标准差 10.6），60.7%在基线时使用胰岛素，平均基线 HbA1c 为 9.1（标准差 1.0）。对于 287 名（52.5%）患者，医生报告将 HbA1c 作为共同目标，对于 260 名（47.5%）患者则作为非共同目标。2 年后有 235 名（43.0%）患者达到 HbA1c 目标，312 名（57.0%）患者未达到。多变量分析表明，HbA1c 目标的共同设定与非共同设定、年龄、性别和教育程度与 HbA1c 目标的达成无关。然而，没有伴侣的患者达到目标的风险更高（p=0.003；OR 1.89；95%CI 1.25-2.86）。