Hermanns Norbert, Bitton Gabriel, Reimer André, Krichbaum Michael, Kulzer Bernhard, Haak Thomas
Research Institute Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany Diabetes Center Mergentheim, Bad Mergentheim, Germany
Insuline Medical, Petach Tikvah, Israel.
J Diabetes Sci Technol. 2014 Nov;8(6):1126-32. doi: 10.1177/1932296814546162. Epub 2014 Aug 11.
The InsuPad is a medical device to accelerate insulin resorption by applying local heat at the insulin injection site. This crossover study examined the impact of the InsuPad use on postprandial glucose excursions under daily life conditions. In 1 study phase, diabetic patients used the InsuPad when injecting bolus insulin before breakfast and dinner and measured their blood glucose 5 times daily (before breakfast, lunch, and dinner and after breakfast and dinner). In the other study phase, blood glucose measurements were maintained without using the InsuPad. The order of the study phases was randomized. Twenty patients with a high insulin demand took part (30% type 1 diabetes, age 53.7 ± 8.9 years, diabetes duration 14.9 ± 7.4 years; HbA1c 8.3 ± 0.8%; total daily insulin demand 0.97 ± 0.32 IU per kg). Postprandial glucose excursion was reduced by 15.4 mg/dl (95% CI 9.7-21.2 mg/dl; P = .011) after breakfast and dinner if InsuPad was used. The mean blood glucose was lower by 8.8 mg/dl (95% CI 0:3-18:0 mg/dl; P = .099) when using the InsuPad. Safety parameters and the percentage of hypoglycemic (< 60 mg/dl) or hyperglycemic (> 300 mg/dl) blood glucose measurements were not negatively affected by InsuPad use (hypoglycemic values 1.4% vs 1.5%, P = .961; hyperglycemic values 2.6% vs 4.0%, P = .098). Local heating of the insulin injection site by use of the InsuPad device is an effective and safe method to reduce postprandial blood glucose excursions under daily life conditions without negative side effects on the occurrence of low or high blood glucose values.
胰岛素吸收垫是一种通过在胰岛素注射部位施加局部热量来加速胰岛素吸收的医疗器械。这项交叉研究考察了在日常生活条件下使用胰岛素吸收垫对餐后血糖波动的影响。在一个研究阶段,糖尿病患者在早餐和晚餐前注射大剂量胰岛素时使用胰岛素吸收垫,并每天测量5次血糖(早餐、午餐和晚餐前以及早餐和晚餐后)。在另一个研究阶段,不使用胰岛素吸收垫进行血糖测量。研究阶段的顺序是随机的。20名胰岛素需求量大的患者参与了研究(1型糖尿病患者占30%,年龄53.7±8.9岁,糖尿病病程14.9±7.4年;糖化血红蛋白8.3±0.8%;每日胰岛素总需求量为每千克0.97±0.32国际单位)。如果使用胰岛素吸收垫,早餐和晚餐后的餐后血糖波动降低了15.4毫克/分升(95%置信区间9.7 - 21.2毫克/分升;P = 0.011)。使用胰岛素吸收垫时,平均血糖降低了8.8毫克/分升(95%置信区间0.3 - 18.0毫克/分升;P = 0.099)。胰岛素吸收垫的使用对安全参数以及低血糖(<60毫克/分升)或高血糖(>300毫克/分升)血糖测量的百分比没有负面影响(低血糖值1.4%对1.5%,P = 0.961;高血糖值2.6%对4.0%,P = 0.098)。在日常生活条件下,使用胰岛素吸收垫装置对胰岛素注射部位进行局部加热是一种有效且安全的方法,可减少餐后血糖波动,且对低血糖或高血糖值的发生没有负面影响。