长期使用胰岛素自动给药系统可改善因低血糖意识受损而并发的长期1型糖尿病患者的睡眠。

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Journal of Diabetes Science and Technology Pub Date : 2024-11-01 Epub Date: 2023-07-14 DOI:10.1177/19322968231182406
Susan Kohl Malone, Austin M Matus, Anneliese J Flatt, Amy J Peleckis, Laura Grunin, Gary Yu, Sooyong Jang, James Weimer, Insup Lee, Michael R Rickels, Namni Goel
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Actigraphs and CGM measured sleep and glycemic control at baseline (one week) and months 3, 6, 9, 12, 15, and 18 (three weeks) following AID initiation. HypoCount software integrated actigraphy with CGM data to separate wake and sleep-associated glycemic measures. Paired sample <i>t</i>-tests and Cohen's <i>d</i> effect sizes modeled changes and their magnitude in sleep, glycemic control, IAH (Clarke score), hypoglycemia severity (HYPO score), hypoglycemia exposure (CGM), and glycemic variability (lability index [LI]; CGM coefficient-of-variation [CV]) from baseline to 18 months.</p><p><strong>Results: </strong>Sleep improved from baseline to 18 months (shorter sleep latency [<i>P</i> < .05, <i>d</i> = 1.74], later sleep offset [<i>P</i> < .05, <i>d</i> = 0.90], less wake after sleep onset [<i>P</i> < .01, <i>d</i> = 1.43]). Later sleep onset (<i>d</i> = 0.74) and sleep midpoint (<i>d</i> = 0.77) showed medium effect sizes. 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引用次数: 0

摘要

背景本研究评估了启动胰岛素自动给药(AID)后动图估算的睡眠和血糖结果的变化:10名长期患有1型糖尿病且低血糖意识受损(IAH)的成人参加了一项为期18个月的临床试验,评估自动胰岛素给药干预对低血糖和反调节机制的影响。本次分析采用了 8 名参与者(中位年龄为 58 岁)的数据,他们同时提供了腕部活动计和连续血糖监测(CGM)数据。腕动仪和连续血糖监测仪分别在基线(一周)和开始使用 AID 后的第 3、6、9、12、15 和 18 个月(三周)测量睡眠和血糖控制情况。HypoCount 软件整合了动态心电图和 CGM 数据,以区分清醒时和睡眠时的血糖测量结果。通过配对样本 t 检验和 Cohen's d 效果大小,模拟了从基线到 18 个月期间睡眠、血糖控制、IAH(Clarke 评分)、低血糖严重程度(HYPO 评分)、低血糖暴露(CGM)和血糖变异性(不稳定性指数 [LI];CGM 变异系数 [CV])的变化及其幅度:结果:从基线到 18 个月,睡眠情况有所改善(睡眠潜伏期缩短[P < .05,d = 1.74],睡眠偏移推迟[P < .05,d = 0.90],睡眠开始后唤醒次数减少[P < .01,d = 1.43])。较晚的睡眠开始时间(d = 0.74)和睡眠中点(d = 0.77)显示出中等效果。在开始使用 AID 后的 12 至 15 个月内,睡眠状况得到明显改善,在此之前,低血糖意识得到改善(Clarke 评分 [d = 1.18]),低血糖严重程度降低(HYPO 评分 [d = 2.13]),减少睡眠相关性低血糖(血糖小于 54 mg/dL、小于 60 mg/dL、小于 70 mg/dL 的时间百分比;d = 0.66-0.81),减少血糖变异性(LI,d = 0.86;CV,d = 0.62):AID改善了睡眠的开始和维持。在睡眠改善之前,低血糖意识的提高、低血糖严重程度的降低、低血糖暴露的减少以及血糖变异性的降低都会改善睡眠。本试验已在 ClinicalTrials.gov NCT03215914 https://clinicaltrials.gov/ct2/show/NCT03215914 上注册。
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Prolonged Use of an Automated Insulin Delivery System Improves Sleep in Long-Standing Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia.

Background: This study assessed changes in actigraphy-estimated sleep and glycemic outcomes after initiating automated insulin delivery (AID).

Methods: Ten adults with long-standing type 1 diabetes and impaired awareness of hypoglycemia (IAH) participated in an 18-month clinical trial assessing an AID intervention on hypoglycemia and counter-regulatory mechanisms. Data from eight participants (median age = 58 years) with concurrent wrist actigraph and continuous glucose monitoring (CGM) data were used in the present analyses. Actigraphs and CGM measured sleep and glycemic control at baseline (one week) and months 3, 6, 9, 12, 15, and 18 (three weeks) following AID initiation. HypoCount software integrated actigraphy with CGM data to separate wake and sleep-associated glycemic measures. Paired sample t-tests and Cohen's d effect sizes modeled changes and their magnitude in sleep, glycemic control, IAH (Clarke score), hypoglycemia severity (HYPO score), hypoglycemia exposure (CGM), and glycemic variability (lability index [LI]; CGM coefficient-of-variation [CV]) from baseline to 18 months.

Results: Sleep improved from baseline to 18 months (shorter sleep latency [P < .05, d = 1.74], later sleep offset [P < .05, d = 0.90], less wake after sleep onset [P < .01, d = 1.43]). Later sleep onset (d = 0.74) and sleep midpoint (d = 0.77) showed medium effect sizes. Sleep improvements were evident from 12 to 15 months after AID initiation and were preceded by improved hypoglycemia awareness (Clarke score [d = 1.18]), reduced hypoglycemia severity (HYPO score [d = 2.13]), reduced sleep-associated hypoglycemia (percent time glucose was < 54 mg/dL, < 60 mg/dL,< 70 mg/dL; d = 0.66-0.81), and reduced glucose variability (LI, d = 0.86; CV, d = 0.62).

Conclusion: AID improved sleep initiation and maintenance. Improved awareness of hypoglycemia, reduced hypoglycemia severity, hypoglycemia exposure, and glucose variability preceded sleep improvements.This trial is registered with ClinicalTrials.gov NCT03215914 https://clinicaltrials.gov/ct2/show/NCT03215914.

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来源期刊
Journal of Diabetes Science and Technology
Journal of Diabetes Science and Technology Medicine-Internal Medicine
CiteScore
7.50
自引率
12.00%
发文量
148
期刊介绍: The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.
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