A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps
A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps
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DOI：
10.1007/s00592-019-01300-1
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发表时间：
2019-06-01
影响因子：
3.8
通讯作者：
Pinhas-Hamiel, Orit
中科院分区：
文献类型：
--
作者：
Yaron, Marianna;Sher, Bruria;Pinhas-Hamiel, Orit
方法74例接受胰岛素泵治疗至少1年（平均19.5 [11.5]年）且HbA 1（c）6.5%（48 mmol/mol）的T1 D患者随机分为远程医疗组（n=37）和标准治疗组（n=37）。干预组被指示每月从胰岛素泵和血糖仪下载数据。他们立即接受电话反馈和胰岛素剂量调整建议; 6个月内进行一次面对面访视，而标准治疗组每3个月进行一次。治疗，生活质量和低血糖事件的频率的满意度进行了evaluated.ResultsThe调整到基线的HbA 1c的平均变化分别为-0.08%（0.25 mmol/mol）与-0.01%（0.03 mmol/mol），在干预组和对照组，分别（p=0.18）在12个月，没有增加低血糖的频率。干预组患者感到满意，并有兴趣继续治疗（p=0.04）。两组的生活质量评分相似。直接总成本减少24%，在干预组，间接总成本下降了22%，相比前一年的study. ConclusionsInternet为基础的胰岛素剂量调整是有效和安全的常规护理在成人1型糖尿病治疗胰岛素泵。对于合适的患者，一些耗时的常规访视可能会被用户友好的数字医学所取代。临床试验注册Clinical Trial.gov标识符NCT 01887431。
AimTo examine the effectiveness and safety over a 12-month period of a telemedicine intervention in adults with type 1 diabetes (T1D) treated with insulin pumps.Methods74 T1D patients on insulin pumps for at least 1 year (mean 19.5 [11.5] years) and HbA1(c)6.5% (48mmol/mol) were randomized to the telemedicine (n=37) or the standard care group (n=37). The intervention group was instructed to download data from insulin pumps and glucometers monthly. They received immediate phone feedback and recommendations for insulin dose adjustment; and face-to-face visits once in 6 months, compared to once every 3months for the standard care group. Satisfaction with treatment, quality of life and frequency of hypoglycemic events was evaluated.ResultsThe mean changes in HbA1c adjusted to baseline were -0.08% (0.25mmol/mol) vs. -0.01% (0.03mmol/mol), in the intervention and control groups, respectively (p=0.18) at 12 months, without an increased frequency of hypoglycemia. Patients in the intervention group felt satisfied and interested in continuing with the treatment (p=0.04). The quality of life scores were similar in both groups. Direct total costs were 24% less in the intervention group, and indirect total costs decreased by 22% compared to the year preceding the study.ConclusionsInternet-based insulin dose adjustment is as effective and safe as routine care in adults with type 1 diabetes treated by insulin pumps. For suitable patients, some of the time-consuming routine visits may be replaced by user-friendly digital medicine.Clinical trial registrationClinical Trial.gov Identifier NCT01887431.