School of Psychology, Deakin University, Geelong, Australia.
The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, Australia.
Diabetes Technol Ther. 2019 Nov;21(11):619-626. doi: 10.1089/dia.2019.0152. Epub 2019 Oct 9.
In the HypoCOMPaSS trial, adults with long-standing type 1 diabetes and problematic hypoglycemia were randomized to compare insulin pump (continuous subcutaneous insulin infusion; CSII) with multiple daily injections (MDI) and real-time continuous glucose monitoring (RT-CGM) with conventional self-monitoring of blood glucose (SMBG). Our aim was to investigate participants' satisfaction with these technologies at 6-month randomized, controlled trial (RCT) endpoint and at 2-year follow-up. Participants completed the Insulin Treatment Satisfaction Questionnaire subscales "device delivery" and "hypoglycemia control"; and Glucose Monitoring Experience Questionnaire, assessing "convenience", "effectiveness", "intrusiveness", and "total satisfaction." We assessed change over time and between-group differences by insulin and monitoring modalities. Participants ( = 96) were 64% women, aged 49 ± 12 years, with a diabetes duration of 29 ± 12 years. At 6 months, participants reported improvements compared with baseline (all < 0.001) in satisfaction with insulin "delivery device" ( 0.39) and "hypoglycemia control" ( = 0.52), and trends toward significance in perceived "effectiveness" ( 0.42) and "intrusiveness" ( = 0.27) of monitoring device (but not "convenience", = 0.139). All improvements were sustained at 2 years. At 6 months, the only difference between arms was that greater satisfaction with insulin "delivery device" was reported in the CSII group compared with MDI ( < 0.001, = 0.40). No between-group differences were observed at 2 years. Overall, significant improvements in participant satisfaction with diabetes technologies were observed over the 6-month RCT, in all domains except "convenience," and maintained at 2 years. Although HypoCOMPaSS demonstrated noninferiority of SMBG versus CGM, and MDI versus CSII in terms of biomedical outcomes, detailed assessments confirm that participants' satisfaction with delivery device was greater in those allocated to CSII than MDI.
在 HypoCOMPaSS 试验中，患有长期 1 型糖尿病且存在低血糖问题的成年人被随机分配，以比较胰岛素泵（持续皮下胰岛素输注；CSII）与多次皮下注射（MDI）和实时连续血糖监测（RT-CGM）与传统的自我血糖监测（SMBG）。我们的目的是在 6 个月随机对照试验（RCT）终点和 2 年随访时，调查参与者对这些技术的满意度。参与者完成了胰岛素治疗满意度问卷子量表“设备输送”和“低血糖控制”；以及血糖监测体验问卷，评估“便利性”、“有效性”、“侵入性”和“总体满意度”。我们通过胰岛素和监测方式评估随时间的变化和组间差异。参与者（ = 96）中有 64%为女性，年龄 49±12 岁，糖尿病病程 29±12 年。在 6 个月时，与基线相比，参与者报告满意度有所提高（均<0.001），包括对胰岛素“输送设备”（ 0.39）和“低血糖控制”（ = 0.52）的满意度，以及监测设备的“有效性”（ 0.42）和“侵入性”（ = 0.27）的趋势（但“便利性”则没有， = 0.139）。所有的改善都持续到 2 年。在 6 个月时，两组之间唯一的区别是 CSII 组报告对胰岛素“输送设备”的满意度更高，而 MDI 组则更低（<0.001， = 0.40）。在 2 年时没有观察到组间差异。总的来说，在 6 个月的 RCT 中，参与者对糖尿病技术的满意度在所有领域都有显著提高，除了“便利性”，并且在 2 年内保持不变。尽管 HypoCOMPaSS 在生物医学结果方面证明了 SMBG 与 CGM 相比和 MDI 与 CSII 相比不劣效性，但详细评估证实，分配给 CSII 的参与者对输送设备的满意度高于 MDI。
