Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.
Diabetes Obes Metab. 2023 Nov;25(11):3103-3113. doi: 10.1111/dom.15204. Epub 2023 Jul 24.
To conduct a systematic review of studies assessing adaptive insulin bolus calculators for people with type 1 diabetes (T1D).
Electronic databases (Medline, Embase and Web of Science) were systematically searched from date of inception to 13 October 2022 for single-arm or randomized controlled studies assessing adaptive bolus calculators only, in children or adults with T1D on multiple daily injections or insulin pumps with glycaemic outcomes reported. The Clinicaltrials.gov registry was searched for recently completed studies evaluating decision support in T1D. The quality of extracted studies was assessed using the Standard Quality Assessment criteria and the Cochrane Risk of Bias assessment tool.
Six studies were identified. Extracted data were synthesized in a descriptive review because of heterogeneity. All the studies were small feasibility studies or were not suitably powered, and all were deemed to be at a high risk of performance and detection bias because they were unblinded. Overall, these studies did not show a significant glycaemic improvement. Two studies showed a reduction in postprandial time below range or an incremental change in blood glucose concentration; however, these were in controlled environments over a short duration.
There are limited clinical trials evaluating adaptive bolus calculators. Although results from small trials or in-silico data are promising, further studies are required to support personalized and adaptive management of T1D.
系统评价评估 1 型糖尿病（T1D）患者使用的适应性胰岛素推注计算器的研究。
从建库日期到 2022 年 10 月 13 日，系统检索电子数据库（Medline、Embase 和 Web of Science），以评估仅使用适应性推注计算器的单臂或随机对照研究，研究对象为接受多次每日注射或胰岛素泵治疗的 T1D 儿童或成人，报告血糖结果。检索 Clinicaltrials.gov 注册处，以评估 T1D 中决策支持的最近完成的研究。使用标准质量评估标准和 Cochrane 偏倚风险评估工具评估提取研究的质量。
确定了 6 项研究。由于存在异质性，提取的数据在描述性综述中进行了综合。所有研究均为小型可行性研究或没有足够的效力，由于未设盲，所有研究均被认为存在较高的操作和检测偏倚风险。总体而言，这些研究并未显示出明显的血糖改善。两项研究显示餐后时间低于目标范围或血糖浓度的增量变化有所减少；然而，这些都是在短时间内的受控环境中进行的。
评估适应性推注计算器的临床试验有限。尽管小型试验或模拟数据的结果很有希望，但仍需要进一步的研究来支持 T1D 的个性化和适应性管理。
