背景:使用MedtronicMiniMed780G(MM780G)AHCL的1型糖尿病(T1D)患者的多个临床医生可调节参数对血糖的影响。这些包括葡萄糖目标,碳水化合物比率(CR),和活性胰岛素时间(AIT)。基于算法的决策支持建议在潜在的设置调整可以增强临床决策。
方法:单臂,两阶段探索性研究开发决策支持,以开始和维持AHCL。参与者开始调查MM780G,然后8周阶段1-初始优化工具评估,涉及基于算法的决策支持,每周AIT和CR建议。临床医生根据每个方案的感知安全性批准或拒绝CR和AIT建议。共同设计导致在进一步相同配置的阶段2中评估的优化算法。第2阶段参与者也在“QuickStart”(使用每日胰岛素剂量和体重确定初始AHCL设置的算法衍生工具)之后过渡到商用MM780G。我们评估了疗效,安全,以及使用血糖指标的决策支持的可接受性,以及每个阶段接受的CR和AIT设置的比例。
结果:53名参与者开始第一阶段(平均年龄24.4;Hba1c为61.5mmol/7.7%)。临床医生接受的CR和AIT比例分别在第1阶段和第2阶段之间增加:CR89.2%与98.6%,p<0.01;AIT95.2%vs.99.3%,p<0.01。在阶段之间,平均葡萄糖百分比时间<3.9mmol(<70mg/dl)减少(2.1%vs.1.4%,p=0.04);平均TIR3.9-10mmol/L(70-180mg/dl)的变化无统计学意义:72.9%±7.8和73.5%±8.6。快速启动导致稳定的TIR,和血糖指标与国际指南的比较。
结论:共同设计的决策支持工具能够提供安全有效的治疗。它们可以潜在地减轻医疗保健从业人员和患者的糖尿病管理相关决策的负担。
背景:于2021年3月30日在澳大利亚/新西兰临床试验注册中心(ANZCTR)进行了前瞻性注册,作为研究ACTRN12621000360819。
BACKGROUND: Multiple clinician adjustable parameters impact upon glycemia in people with type 1 diabetes (T1D) using Medtronic Mini Med 780G (MM780G) AHCL. These include glucose targets, carbohydrate ratios (CR), and active insulin time (AIT). Algorithm-based decision support advising upon potential settings adjustments may enhance clinical decision-making.
METHODS: Single-arm, two-phase exploratory study developing decision support to commence and sustain AHCL. Participants commenced investigational MM780G, then 8 weeks Phase 1-initial optimization tool evaluation, involving algorithm-based decision support with weekly AIT and CR recommendations. Clinicians approved or rejected CR and AIT recommendations based on perceived safety per protocol. Co-design resulted in a refined algorithm evaluated in a further identically configured Phase 2. Phase 2 participants also transitioned to commercial MM780G following \"Quick Start\" (algorithm-derived tool determining initial AHCL settings using daily insulin dose and weight). We assessed efficacy, safety, and acceptability of decision support using glycemic metrics, and the proportion of accepted CR and AIT settings per phase.
RESULTS: Fifty three participants commenced Phase 1 (mean age 24.4; Hba1c 61.5mmol/7.7%). The proportion of CR and AIT accepted by clinicians increased between Phases 1 and 2 respectively: CR 89.2% vs. 98.6%, p < 0.01; AIT 95.2% vs. 99.3%, p < 0.01. Between Phases, mean glucose percentage time < 3.9mmol (< 70mg/dl) reduced (2.1% vs. 1.4%, p = 0.04); change in mean TIR 3.9-10mmol/L (70-180mg/dl) was not statistically significant: 72.9% ± 7.8 and 73.5% ± 8.6. Quick start resulted in stable TIR, and glycemic metrics compared to international guidelines.
CONCLUSIONS: The co-designed decision support tools were able to deliver safe and effective therapy. They can potentially reduce the burden of diabetes management related decision making for both health care practitioners and patients.
BACKGROUND: Prospectively registered with Australia/New Zealand Clinical Trials Registry(ANZCTR) on 30th March 2021 as study ACTRN12621000360819.