Snel Tim, Reinhardt Sven, Koenig Helena, Pleus Stefan, Freckmann Guido
Roche Diabetes Care Nederland B.V., Almere, The Netherlands.
Roche Diabetes Care GmbH, Mannheim, Germany.
Diabetes Ther. 2024 Nov;15(11):2429-2441. doi: 10.1007/s13300-024-01650-2. Epub 2024 Sep 30.
The shortage of general practitioners (GPs) and the increasing prevalence of type 2 diabetes create significant pressure on primary healthcare services. To enable that medical services are available to all that need it, innovative solutions are needed. One of those, a Short Message Service (SMS)-supported basal insulin titration service is investigated in this study. The primary objective was to determine the percentage of subjects who achieved stable fasting blood glucose (FBG) within their individual target range with this service after week 16.
This single-arm, 16-week study aimed to enroll 111 adults diagnosed with type 2 diabetes that needed insulin. The study subjects measured their FBG 4 consecutive days to establish a baseline, then received SMS prompts for daily FBG measurements and evening insulin injections until their FBG stabilized within the target range. Adjusting the insulin based on the FBG. Once stabilization was achieved, subjects continued with their optimal insulin dose for the remainder of the study. Sixteen weeks after the baseline, subjects measured FBG for 4 days before visit 4, where these values were read by the healthcare provider.
Out of the planned 111 subjects, only 30 were enrolled, with one withdrawal prior to service activation. Challenges in subject recruitment were attributed to the COVID-19 outbreak, limited eligibility, competing studies, and new medications delaying insulin initiation. Subjects were on average 59.97 years old, had an HbA1c of 9.29% a FBG of 205.64 mg/dl, and had diabetes for 10 years. Among the 29 subjects who started the service, 72% achieved successful titration at visit 4, with a median time of 49 days. Notable improvements were observed in HbA1c levels (decreased by 1.58%) and FBG levels (decreased by 64 mg/dl) over the 16-week study period. No adverse events or device-related issues were reported.
Despite recruitment challenges, guided basal insulin titration holds promise for insulin therapy initiation in individuals. The findings emphasize the potential of tele-medical approaches, specifically through remote messaging, in managing diabetes and improving therapy adherence.
全科医生短缺以及2型糖尿病患病率上升给基层医疗服务带来了巨大压力。为了使医疗服务能够覆盖所有有需求的人，需要创新的解决方案。本研究对其中一种解决方案——短信支持的基础胰岛素滴定服务进行了调查。主要目标是确定在第16周后通过该服务使空腹血糖（FBG）在个体目标范围内达到稳定的受试者百分比。
这项单臂、为期16周的研究旨在招募111名被诊断为2型糖尿病且需要胰岛素治疗的成年人。研究对象连续4天测量其空腹血糖以建立基线，然后接收每日空腹血糖测量和夜间胰岛素注射的短信提示，直到其空腹血糖在目标范围内稳定。根据空腹血糖调整胰岛素剂量。一旦达到稳定状态，受试者在研究的剩余时间内继续使用最佳胰岛素剂量。基线后16周，受试者在第4次就诊前4天测量空腹血糖，这些值由医疗服务提供者读取。
计划招募的111名受试者中，仅30名被纳入研究，其中1名在服务启动前退出。受试者招募面临的挑战归因于新冠疫情爆发、入选标准有限、竞争研究以及新药物推迟胰岛素起始治疗。受试者平均年龄为59.97岁，糖化血红蛋白（HbA1c）为9.29%，空腹血糖为205.64mg/dl，患糖尿病10年。在开始使用该服务的29名受试者中，72%在第4次就诊时成功滴定，中位时间为49天。在为期16周的研究期间，糖化血红蛋白水平（下降1.58%）和空腹血糖水平（下降64mg/dl）有显著改善。未报告不良事件或与设备相关的问题。
尽管存在招募挑战，但指导性基础胰岛素滴定对个体胰岛素治疗起始具有前景。研究结果强调了远程医疗方法，特别是通过远程消息传递，在管理糖尿病和提高治疗依从性方面的潜力。
