背景:在1型糖尿病中,碳水化合物计数是确定膳食胰岛素需求的护理标准,但它会对生活质量产生负面影响。我们开发了一种新型的胰岛素和普兰林肽闭环系统,该系统用简单的膳食公告代替了碳水化合物计数。
方法:我们进行了一项随机交叉试验,评估了14天的(1)胰岛素和普兰林肽闭环系统,(2)含碳水化合物计数的胰岛素-安慰剂闭环系统,和(3)胰岛素和安慰剂闭环系统,简单的膳食公告。参与者在麦吉尔大学健康中心(蒙特利尔,QC,加拿大)。符合条件的参与者是患有1型糖尿病至少1年的成年人(年龄≥18岁)和青少年(年龄12-17岁)。参与者以1:1:1:1:1:1的比例随机分配到三个干预措施的序列中,在所有干预措施中使用更快的胰岛素。每个干预措施都分为14-45天的清洗期,在此期间,参与者恢复了他们通常的胰岛素。在简单的膳食公告干预中,参与者根据编程的固定膳食大小在进餐时间触发了餐时推注,而在碳水化合物计数干预期间,参与者手动输入膳食中的碳水化合物含量,算法根据胰岛素与碳水化合物的比例计算餐时推注.两个主要比较是预先定义的:时间百分比范围(葡萄糖3·9-10·0mmol/L),非劣效性边缘为6·25%(非劣效性比较);以及糖尿病困扰量表的平均情绪负担子量表得分(优势比较),比较胰岛素和安慰剂系统与碳水化合物计数减去胰岛素和普兰林肽系统与简单的膳食通知。分析是在改良的意向治疗基础上进行的,排除未完成所有干预措施的参与者.对所有参与者进行严重不良事件评估。该试验在ClinicalTrials.gov上注册,NCT04163874。
结果:在2020年2月14日至2021年10月5日之间招募了32名参与者;两名参与者在研究完成前退出。对30名参与者进行了分析,包括15名成年人(9名女性,平均年龄39·4岁[SD13·8])和15名青少年(8名女性,平均年龄15·7岁[1·3])。与具有碳水化合物计数的胰岛素和安慰剂系统相比,具有简单膳食通知的胰岛素和普兰林肽系统具有非劣效性(差异-5%[95%CI-9·0至-0·7],非劣效性p<0·0001)。简单膳食通知的胰岛素和普兰林肽系统与碳水化合物计数的胰岛素和安慰剂系统之间的平均情绪负担评分无统计学差异(差异0·01[SD0·82],p=0·93)。胰岛素和普兰林肽系统带有简单的膳食通知,14(47%)参与者报告轻度胃肠道症状,2(7%)报告中度症状。相比之下,有2名(7%)参与者在胰岛素和安慰剂系统中报告了轻度的胃肠道症状并进行了碳水化合物计数.无严重不良事件发生。
结论:胰岛素和普兰林肽系统与简单的膳食通知减轻碳水化合物计数而不降低血糖控制,尽管以情绪负担评分衡量的生活质量没有改善。有必要对这种新颖方法进行更长时间和更大的研究。
背景:青少年糖尿病研究基金会.
BACKGROUND: In type 1 diabetes, carbohydrate counting is the standard of care to determine prandial insulin needs, but it can negatively affect quality of life. We developed a novel insulin-and-pramlintide closed-loop system that replaces carbohydrate counting with simple meal announcements.
METHODS: We performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements. Participants were recruited at McGill University Health Centre (Montreal, QC, Canada). Eligible participants were adults (aged ≥18 years) and adolescents (aged 12-17 years) with type 1 diabetes for at least 1 year. Participants were randomly assigned in a 1:1:1:1:1:1 ratio to a sequence of the three interventions, with faster insulin aspart used in all interventions. Each intervention was separated by a 14-45-day wash-out period, during which participants reverted to their usual insulin. During simple meal announcement interventions, participants triggered a prandial bolus at mealtimes based on a programmed fixed meal size, whereas during carbohydrate counting interventions, participants manually entered the carbohydrate content of the meal and an algorithm calculated the prandial bolus based on insulin-to-carbohydrate ratio. Two primary comparisons were predefined: the percentage of time in range (glucose 3·9-10·0 mmol/L) with a non-inferiority margin of 6·25% (non-inferiority comparison); and the mean Emotional Burden subscale score of the Diabetes Distress Scale (superiority comparison), comparing the insulin-and-placebo system with carbohydrate counting minus the insulin-and-pramlintide system with simple meal announcements. Analyses were performed on a modified intention-to-treat basis, excluding participants who did not complete all interventions. Serious adverse events were assessed in all participants. This trial is registered on ClinicalTrials.gov, NCT04163874.
RESULTS: 32 participants were enrolled between Feb 14, 2020, and Oct 5, 2021; two participants withdrew before study completion. 30 participants were analysed, including 15 adults (nine female, mean age 39·4 years [SD 13·8]) and 15 adolescents (eight female, mean age 15·7 years [1·3]). Non-inferiority of the insulin-and-pramlintide system with simple meal announcements relative to the insulin-and-placebo system with carbohydrate counting was reached (difference -5% [95% CI -9·0 to -0·7], non-inferiority p<0·0001). No statistically significant difference was found in the mean Emotional Burden score between the insulin-and-pramlintide system with simple meal announcements and the insulin-and-placebo system with carbohydrate counting (difference 0·01 [SD 0·82], p=0·93). With the insulin-and-pramlintide system with simple meal announcements, 14 (47%) participants reported mild gastrointestinal symptoms and two (7%) reported moderate symptoms, compared with two (7%) participants reporting mild gastrointestinal symptoms on the insulin-and-placebo system with carbohydrate counting. No serious adverse events occurred.
CONCLUSIONS: The insulin-and-pramlintide system with simple meal announcements alleviated carbohydrate counting without degrading glucose control, although quality of life as measured by the Emotional Burden score was not improved. Longer and larger studies with this novel approach are warranted.
BACKGROUND: Juvenile Diabetes Research Foundation.