Peabody John W, Paculdo David, de Belen Enrico, Ganesan Divya, Cooney Isabella, Trujillo Nelson
QURE Healthcare, 450 Pacific Ave., Suite 200, San Francisco, CA, 94133, USA.
University of California, San Francisco, 550 16th Street, Third Floor, San Francisco, CA, USA.
Diabetol Metab Syndr. 2023 Jul 13;15(1):155. doi: 10.1186/s13098-023-01122-w.
The risk for and treatment of cardiovascular disease (CVD) in type 2 diabetes (T2DM) is often incorrect and delayed. We wished to determine if a novel test improved physicians' ability to risk stratify, diagnose, and treat patients with T2DM.
In a 2-phase randomized controlled trial comparing the clinical workup, diagnosis, and management of online, simulated patients with T2DM in a nationwide sample of cardiologists and primary care physicians, participants were randomly assigned to control or one of two intervention groups. Intervention participants had access to standard of care diagnostic tools plus a novel diagnostic CVD risk stratification test.
In control, there was no change in CV risk stratification of simulated patients between baseline and round 2 (37.1 to 38.3%, p = 0.778). Pre-post analysis showed significant improvements in risk stratification in both Intervention 1 (38.7 to 65.3%) and Intervention 2 (41.9 to 65.8%) (p < 0.01) compared to controls. Both intervention groups significantly increased prescribing SGLT2 inhibitors/GLP1 receptor agonists versus control, + 18.9% for Intervention 1 (p = 0.020) and 1 + 9.4% for Intervention 2 (p = 0.014). Non-pharmacologic treatment improved significantly compared to control (+ 30.0% in Intervention 1 (p < 0.001) and + 22.8% in Intervention 2 (p = 0.001). Finally, monitoring HgbA1C, blood pressure, and follow-up visit frequency improved by + 20.3% (p = 0.004) in Intervention 1 and + 29.8% (p < 0.001) in Intervention 2 compared with control.
Use of the novel test significantly improved CV risk stratification among T2DM patients. Statistically significant increases treatments were demonstrated, specifically SGLT2 inhibitors and GLP1 receptor antagonists and recommendations of evidence-based non-pharmacologic treatments. Trial registration ClinicalTrials.gov, NCT05237271.
2型糖尿病(T2DM)患者心血管疾病(CVD)的风险评估及治疗常常出现错误且延误。我们希望确定一项新型检测能否提高医生对T2DM患者进行风险分层、诊断及治疗的能力。
在一项两阶段随机对照试验中,比较了全国范围内心脏病专家和初级保健医生对在线模拟T2DM患者的临床检查、诊断和管理情况,参与者被随机分配至对照组或两个干预组之一。干预组参与者可使用标准护理诊断工具以及一项新型CVD风险分层检测。
在对照组中,模拟患者的心血管风险分层在基线和第二轮之间无变化(37.1%至38.3%,p = 0.778)。前后分析显示,与对照组相比,干预1组(38.7%至65.3%)和干预2组(41.9%至65.8%)的风险分层均有显著改善(p < 0.01)。与对照组相比,两个干预组使用钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂/胰高血糖素样肽1(GLP1)受体激动剂的处方量均显著增加,干预1组增加了18.9%(p = 0.020),干预2组增加了19.4%(p = 0.014)。与对照组相比,非药物治疗有显著改善(干预1组增加30.0%,p < 0.001;干预2组增加22.8%,p = 0.001)。最后,与对照组相比,干预1组糖化血红蛋白(HgbA1C)、血压监测及随访就诊频率提高了20.3%(p = 0.004),干预2组提高了29.8%(p < 0.001)。
使用新型检测显著改善了T2DM患者的心血管风险分层。在治疗方面显示出具有统计学意义的增加,特别是SGLT2抑制剂和GLP1受体拮抗剂,以及基于证据的非药物治疗建议。试验注册ClinicalTrials.gov,NCT05237271。