Vallejo Mora María Del Rosario, Carreira Mónica, Anarte María Teresa, Linares Francisca, Olveira Gabriel, González Romero Stella
1 Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga , Málaga, Spain .
2 Instituto de Investigación Biomédica (IBIMA), Hospital Regional Universitario de Málaga , Málaga, Spain .
Diabetes Technol Ther. 2017 Jul;19(7):402-409. doi: 10.1089/dia.2017.0019. Epub 2017 Jun 8.
In a previous study we demonstrated improvement in metabolic control and reduction in hypoglycemia in people with type 1 diabetes on multiple daily injections, after having used a bolus calculator for 4 months.
To demonstrate whether (1) extending its use (2) or introducing it in the control group, previously subjected to treatment intensification, could further improve metabolic control and related psychological issues.
After the previous clinical trial, in which the subjects were randomized either to treatment with the calculator or to control group for 4 months, both groups used the calculator during an additional 4-month period.
In the previous control group, after using the device, HbA1c did not improve (7.86% ± 0.87% vs. 8.01% ± 0.93%, P 0.215), although a significant decrease in postprandial hypoglycemia was observed (2.3 ± 2 vs. 1.1 ± 1.2/2 weeks, P 0.002). In the group in which the treatment was extended from 4 to 8 months, HbA1c did not improve either (7.61 ± 0.58 vs. 7.73 ± 0.65, P 0.209); however this group had a greater perceived treatment satisfaction (12.03 ± 4.26 vs. 13.71 ± 3.75, P 0.007) and a significant decrease in fear of hypoglycemia (28.24 ± 8.18 basal vs. 25.66 ± 8.02 at 8 months, P 0.026).
The extension in the use of the calculator or its introduction in a previously intensified control group did not improve metabolic control, although it did confirm a decrease in hypoglycemic episodes in the short term, while the extension of its use to 8 months was associated with a reduction in fear of hypoglycemia and greater treatment satisfaction.
在之前的一项研究中，我们证明了1型糖尿病患者在多次每日注射治疗时，使用大剂量计算器4个月后，代谢控制得到改善，低血糖发生率降低。
证明（1）延长其使用时间（2）或将其引入先前强化治疗的对照组，是否能进一步改善代谢控制及相关心理问题。
在之前的临床试验中，受试者被随机分为使用计算器治疗组或对照组，为期4个月。之后，两组在额外的4个月期间均使用该计算器。
在之前的对照组中，使用该设备后，糖化血红蛋白（HbA1c）没有改善（7.86%±0.87% vs. 8.01%±0.93%，P>0.215），尽管餐后低血糖显著减少（2.3±2 vs. 1.1±1.2/2周，P<0.002）。在治疗时间从4个月延长至8个月的组中，HbA1c也没有改善（7.61±0.58 vs. 7.73±0.65，P>0.209）；然而，该组的治疗满意度更高（12.03±4.26 vs. 13.71±3.75，P<0.007），对低血糖的恐惧显著降低（基础值28.24±8.18 vs. 8个月时25.66±8.02，P<0.026）。
延长计算器的使用时间或将其引入先前强化治疗的对照组并没有改善代谢控制，尽管确实证实了短期内低血糖发作减少，而将其使用时间延长至8个月与对低血糖的恐惧减少和更高的治疗满意度相关。
