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Time to Moderate and Severe Hyperglycemia and Ketonemia Following an Insulin Pump Occlusion. 胰岛素泵闭塞后出现中度和严重高血糖及酮血症的时间。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-06 DOI: 10.1177/19322968241280386
David C Klonoff, Alessandra T Ayers, Cindy N Ho, Chiara Fabris, María Fernanda Villa-Tamayo, Eleanor Allen, Eda Cengiz, Laya Ekhlaspour, Jenise C Wong, Lutz Heineman, Michael A Kohn

Introduction: Insulin pump therapy can be adversely affected by interruption of insulin flow, leading to a rise in blood glucose (BG) and subsequently of blood beta-hydroxybutyrate (BHB) ketone levels.

Methods: We performed a PubMed search for English language reports (January 1982 to July 2024) estimating the rate of rise in BG and/or BHB after ≥ 60 minutes of interruption of continuous subcutaneous insulin infusion (CSII) in persons with type 1 diabetes (PwT1D). We also simulated the rise in BG in a virtual population of 100 adults with T1D following suspension of continuous subcutaneous insulin infusion.

Results: We identified eight relevant studies where BG and BHB (seven of these eight studies) were measured following suspension of CSII as a model for occlusion. After 60 minutes post-suspension, the mean extracted rates of rise averaged 0.62 mg/dL/min (37 mg/dL/h) for BG and 0.0038 mmol/L/min (0.20 mmol/L/h) for BHB. Mean estimated time to moderately/severely elevated BG (300/400 mg/dL) or BHB (1.6/3.0 mmol/L) was, respectively, 5.8/8.5 and 8.0/14.2 hours. The simulation model predicted moderately/severely elevated BG (300/400 mg/dL) after 9.25/12, 6.75/8.75, and 4.75/5.75 hours in the virtual subjects post-interruption with small (5th percentile), medium (50th percentile), and large (95th percentile) hyperglycemic changes.

Discussion: Clinical studies and a simulation model similarly predicted that, following CSII interruption, moderate/severe hyperglycemia can occur within 5-9/6-14 hours, and clinical studies predicted that moderate/severe ketonemia can occur within 7-12/13-21 hours. Patients and clinicians should be aware of this timing when considering the risks of developing metabolic complications after insulin pump occlusion.

简介:胰岛素泵疗法可能会因胰岛素流量中断而受到不利影响,导致血糖(BG)升高,进而引起血液中β-羟丁酸(BHB)酮体水平升高:我们在 PubMed 上搜索了有关 1 型糖尿病患者(PwT1D)在连续皮下注射胰岛素(CSII)中断≥ 60 分钟后血糖和/或 BHB 升高率的英文报告(1982 年 1 月至 2024 年 7 月)。我们还模拟了由 100 名 T1D 成人组成的虚拟人群在暂停持续皮下注射胰岛素后血糖的升高情况:我们确定了八项相关研究,其中七项研究在作为闭塞模型的 CSII 暂停后测量了血糖和血胆固醇。悬浮后 60 分钟,BG 的平均提取上升率为 0.62 mg/dL/min (37 mg/dL/h) ,BHB 的平均提取上升率为 0.0038 mmol/L/min (0.20 mmol/L/h)。估计到 BG(300/400 mg/dL)或 BHB(1.6/3.0 mmol/L)中度/重度升高的平均时间分别为 5.8/8.5 小时和 8.0/14.2 小时。模拟模型预测虚拟受试者在中断后 9.25/12、6.75/8.75 和 4.75/5.75 小时后血糖(300/400 毫克/分升)中度/重度升高,高血糖变化较小(第 5 百分位数)、中等(第 50 百分位数)和较大(第 95 百分位数):讨论:临床研究和模拟模型同样预测,中断 CSII 后,中度/重度高血糖可在 5-9/6-14 小时内发生,临床研究预测,中度/重度酮血可在 7-12/13-21 小时内发生。患者和临床医生在考虑胰岛素泵闭塞后发生代谢并发症的风险时,应注意这个时间点。
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引用次数: 0
Bridging the Glycemic Gap: Will CMS-Mandated Reporting Improve Hospital Dysglycemia Management? 缩小血糖差距:CMS 规定的报告制度能否改善医院的血糖异常管理?
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-03 DOI: 10.1177/19322968241279278
Mihail Zilbermint, Jordan Messler, Camille Frances Stanback, Kristen Kulasa, Andrew P Demidowich
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引用次数: 0
Concept and Implementation of a Novel Continuous Glucose Monitoring Solution With Glucose Predictions on Board. 带有葡萄糖预测功能的新型连续葡萄糖监测解决方案的概念与实施。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-01 Epub Date: 2024-08-19 DOI: 10.1177/19322968241269927
Timor Glatzer, Christian Ringemann, Daniel Militz, Wiebke Mueller-Hoffmann

The recently CE-marked continuous real-time glucose monitoring (rtCGM) solution Accu-Chek® (AC) SmartGuide Solution was developed to enable people with diabetes mellitus (DM) to proactively control their glucose levels using predictive technologies. The comprehensive solution consists of three components that harmonize well with each other. The CGM device is composed of a sensor applicator and a glucose sensor patch whose data are transferred to the connected smartphone by Bluetooth® Low Energy. The user interface of the CGM solution is powered by the AC SmartGuide app delivering current and past glucose metrics, and the AC SmartGuide Predict app providing a glucose prediction suite enabled by artificial intelligence (AI). This article describes the innovative CGM solution.

最近获得 CE 认证的连续实时血糖监测(rtCGM)解决方案 Accu-Chek® (AC) SmartGuide Solution 是为糖尿病(DM)患者利用预测技术主动控制血糖水平而开发的。该综合解决方案由三个相互协调的组件组成。CGM 设备由传感器涂抹器和葡萄糖传感器贴片组成,其数据通过蓝牙® 低能耗传输到连接的智能手机。CGM 解决方案的用户界面由 AC SmartGuide 应用程序和 AC SmartGuide Predict 应用程序提供支持,前者提供当前和过去的血糖指标,后者提供人工智能(AI)支持的血糖预测套件。本文介绍了创新型 CGM 解决方案。
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引用次数: 0
Regarding Singh et al, "Effects, Safety, and Treatment Experience of Advanced Hybrid Closed-Loop Systems in Clinical Practice Among Adults Living With Type 1 Diabetes". 关于 Singh 等人,"先进的混合闭环系统在 1 型糖尿病成人临床实践中的效果、安全性和治疗经验"。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-01 Epub Date: 2024-05-27 DOI: 10.1177/19322968241257003
Laurel H Messer, John B Welsh, Steph Habif, Jordan E Pinsker, Tomas C Walker
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引用次数: 0
All Children Deserve to Be Safe, Mothers Too: Evidence and Rationale Supporting Continuous Glucose Monitoring Use in Gestational Diabetes Within the Medicaid Population. 所有儿童和母亲都应享有安全:支持在医疗补助人群中使用 CGM 治疗妊娠糖尿病的证据和理由。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-01 Epub Date: 2023-03-15 DOI: 10.1177/19322968231161317
Carol J Levy, Rodolfo J Galindo, Christopher G Parkin, Jacob Gillis, Nicholas B Argento

Gestational diabetes mellitus (GDM) is a common metabolic disease of pregnancy that threatens the health of several million women and their offspring. The highest prevalence of GDM is seen in women of low socioeconomic status. Women with GDM are at increased risk of adverse maternal outcomes, including increased rates of Cesarean section delivery, preeclampsia, perineal tears, and postpartum hemorrhage. However, of even greater concern is the increased risk to the fetus and long-term health of the child due to elevated glycemia during pregnancy. Although the use of continuous glucose monitoring (CGM) has been shown to reduce the incidence of maternal and fetal complications in pregnant women with type 1 diabetes and type 2 diabetes, most state Medicaid programs do not cover CGM for women with GDM. This article reviews current statistics relevant to the incidence and costs of GDM among Medicaid beneficiaries, summarizes key findings from pregnancy studies using CGM, and presents a rationale for expanding and standardizing CGM coverage for GDM within state Medicaid populations.

妊娠糖尿病(GDM)是一种常见的妊娠代谢疾病,威胁着数百万妇女及其后代的健康。社会经济地位低下的妇女罹患 GDM 的比例最高。患有 GDM 的妇女发生不良孕产后果的风险增加,包括剖宫产率增加、子痫前期、会阴撕裂和产后出血。然而,更令人担忧的是,妊娠期血糖升高会增加胎儿和婴儿长期健康的风险。尽管使用连续血糖监测(CGM)已被证明可降低 1 型糖尿病和 2 型糖尿病孕妇的母体和胎儿并发症的发生率,但大多数州的医疗补助计划并不涵盖 GDM 妇女的 CGM。本文回顾了目前与医疗补助受益人中 GDM 发病率和费用相关的统计数据,总结了使用 CGM 进行妊娠研究的主要发现,并提出了扩大和规范各州医疗补助人群中 GDM 的 CGM 覆盖范围的理由。
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引用次数: 0
Implementation and Evaluation of an Automated Text Message-Based Diabetes Prevention Program for Adults With Pre-diabetes. 针对糖尿病前期成人的基于自动短信的糖尿病预防计划的实施与评估。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-01 Epub Date: 2023-03-22 DOI: 10.1177/19322968231162601
Sanjay Arora, Chun Nok Lam, Elizabeth Burner, Michael Menchine

Background: Despite the efficacy of diabetes prevention programs, only an estimated 5% of people with pre-diabetes actually participate. Mobile health (mHealth) holds promise to engage patients with pre-diabetes into lifestyle modification programs by decreasing the referral burden, centralizing remote enrollment, removing the physical requirement of a brick-and-mortar location, lowering operating costs through automation, and reducing time and transportation barriers.

Methods: Non-randomized implementation study enrolling patients with pre-diabetes from a large health care organization. Patients were exposed to a text message-based program combining live human coaching guidance and support with automated scheduled, interactive, data-driven, and on-demand messages. The primary analysis examined predicted weight outcomes at 6 and 12 months. Secondary outcomes included predicted changes in HbA1c and minutes of exercise at 6 and 12 months.

Results: Of the 163 participants included in the primary analysis, participants had a mean predicted weight loss of 5.5% at six months (P < .001) and of 4.3% at 12 months (P < .001). We observed a decrease in predicted HbA1c from 6.1 at baseline to 5.8 at 6 and 12 months (P < .001). Activity minutes were statistically similar from a baseline of 155.5 minutes to 146.0 minutes (P = .567) and 142.1 minutes (P = .522) at 6 and 12 months, respectively, for the overall cohort.

Conclusions: In this real-world implementation of the myAgileLife Diabetes Prevention Program among patients with pre-diabetes, we observed significant decreases in weight and HbA1c at 6 and 12 months. mHealth may represent an effective and easily scalable potential solution to deliver impactful diabetes prevention curricula to large numbers of patients.

背景:尽管糖尿病预防计划很有效,但估计只有 5%的糖尿病前期患者真正参与其中。移动医疗(mHealth)通过减少转诊负担、集中远程登记、取消实体店的物理要求、通过自动化降低运营成本以及减少时间和交通障碍,有望使糖尿病前期患者参与生活方式调整项目:方法:非随机实施研究,招募一家大型医疗机构的糖尿病前期患者。患者接受了一项基于短信的计划,该计划将真人指导和支持与自动计划、互动、数据驱动和按需信息相结合。主要分析检验了 6 个月和 12 个月的体重预测结果。次要结果包括 6 个月和 12 个月后 HbA1c 和运动分钟数的预测变化:结果:在主要分析的 163 名参与者中,6 个月时预测体重平均减轻 5.5%(P < .001),12 个月时预测体重平均减轻 4.3%(P < .001)。我们观察到,预测 HbA1c 从基线时的 6.1 降至 6 个月和 12 个月时的 5.8(P < .001)。总体队列的活动分钟数从基线的 155.5 分钟降至 6 个月和 12 个月时的 146.0 分钟(P = .567)和 142.1 分钟(P = .522),两者在统计学上相似:在这个针对糖尿病前期患者实施的 myAgileLife 糖尿病预防计划的真实世界中,我们观察到体重和 HbA1c 在 6 个月和 12 个月时显著下降。移动医疗可能是一种有效且易于扩展的潜在解决方案,可为大量患者提供有影响力的糖尿病预防课程。
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引用次数: 0
Glycemia Risk Index Assessment in a Pediatric and Adult Patient Cohort With Type 1 Diabetes Mellitus. 1 型糖尿病儿童和成人患者队列中的血糖风险指数评估。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-01 Epub Date: 2023-02-16 DOI: 10.1177/19322968231154561
Gonzalo Díaz-Soto, Paloma Pérez-López, Pablo Férnandez-Velasco, María de la O Nieto de la Marca, Esther Delgado, Sofia Del Amo, Daniel de Luis, Pilar Bahillo-Curieses

Background: To evaluate the glycemia risk index (GRI) as a new glucometry in pediatric and adult populations with type 1 diabetes (T1D) in clinical practice.

Methods: A cross-sectional study of 202 patients with T1D receiving intensive treatment with insulin (25.2% continuous subcutaneous insulin infusion [CSII]) and intermittent scanning (flash) glucose monitoring (isCGM). Clinical and glucometric isCGM data were collected, as well as the component of hypoglycemia (CHypo) and component of hyperglycemia (CHyper) of the GRI.

Results: A total of 202 patients (53% males and 67.8% adults) with a mean age of 28.6 ± 15.7 years and 12.5 ± 10.9 years of T1D evolution were evaluated.Adult patients (>19 years) presented higher glycated hemoglobin (HbA1c) (7.4 ± 1.1 vs 6.7 ± 0.6%; P < .01) and lower time in range (TIR) (55.4 ± 17.5 vs 66.5 ± 13.1%; P < .01) values than the pediatric population, with lower coefficient of variation (CV) (38.6 ± 7.2 vs 42.4 ± 8.9%; P < .05). The GRI was significantly lower in pediatric patients (48.0 ± 22.2 vs 56.8 ± 23.4; P < .05) associated with higher CHypo (7.1 ± 5.1 vs 5.0 ± 4.5; P < .01) and lower CHyper (16.8 ± 9.8 vs 26.5 ± 15.1; P < .01) than in adults.When analyzing treatment with CSII compared with multiple doses of insulin (MDI), a nonsignificant trend to a lower GRI was observed in CSII (51.0 ± 15.3 vs 55.0 ± 25.4; P= .162), with higher levels of CHypo (6.5 ± 4.1 vs 5.4 ± 5.0; P < .01) and lower CHyper (19.6 ± 10.6 vs 24.6 ± 15.2; P < .05) compared with MDI.

Conclusions: In pediatric patients and in those with CSII treatment, despite a better control by classical and GRI parameters, higher overall CHypo was observed than in adults and MDI, respectively. The present study supports the usefulness of the GRI as a new glucometric parameter to evaluate the global risk of hypoglycemia-hyperglycemia in both pediatric and adult patients with T1D.

背景:评估血糖风险指数(GRI)作为一种新的血糖测量方法在儿童和成人 1 型糖尿病(T1D)患者中的临床应用:目的:评估血糖风险指数(GRI)作为一种新的血糖测量方法在1型糖尿病(T1D)儿童和成人临床实践中的应用:对 202 名接受胰岛素强化治疗(25.2% 持续皮下注射胰岛素 [CSII])和间歇扫描(闪烁)血糖监测(isCGM)的 1 型糖尿病患者进行横断面研究。收集了 isCGM 的临床和血糖数据,以及 GRI 的低血糖成分(CHypo)和高血糖成分(CHyper):共评估了 202 名患者(53% 为男性,67.8% 为成人),平均年龄(28.6 ± 15.7)岁,T1D 病程(12.5 ± 10.9)年。与儿科患者相比,成人患者(19 岁以上)的糖化血红蛋白 (HbA1c) 值更高(7.4 ± 1.1 vs 6.7 ± 0.6%;P < .01),范围内时间 (TIR) 值更低(55.4 ± 17.5 vs 66.5 ± 13.1%;P < .01),变异系数 (CV) 更低(38.6 ± 7.2 vs 42.4 ± 8.9%;P < .05)。与成人相比,儿科患者的 GRI 值明显较低(48.0 ± 22.2 vs 56.8 ± 23.4;P < .05),与较高的 CHypo 值(7.1 ± 5.1 vs 5.0 ± 4.5;P < .01)和较低的 CHyper 值(16.8 ± 9.8 vs 26.5 ± 15.1;P < .01)有关。在分析 CSII 与多剂量胰岛素 (MDI) 的治疗情况时,与 MDI 相比,CSII 的 GRI 呈不显著降低趋势(51.0 ± 15.3 vs 55.0 ± 25.4;P= .162),CHypo 水平较高(6.5 ± 4.1 vs 5.4 ± 5.0;P < .01),CHyper 水平较低(19.6 ± 10.6 vs 24.6 ± 15.2;P < .05):在儿童患者和接受 CSII 治疗的患者中,尽管经典参数和 GRI 参数的控制效果更好,但观察到的总体 CHypo 分别高于成人和 MDI。本研究支持将 GRI 作为一种新的血糖测量参数,用于评估 T1D 儿童和成人患者发生低血糖-高血糖的总体风险。
{"title":"Glycemia Risk Index Assessment in a Pediatric and Adult Patient Cohort With Type 1 Diabetes Mellitus.","authors":"Gonzalo Díaz-Soto, Paloma Pérez-López, Pablo Férnandez-Velasco, María de la O Nieto de la Marca, Esther Delgado, Sofia Del Amo, Daniel de Luis, Pilar Bahillo-Curieses","doi":"10.1177/19322968231154561","DOIUrl":"10.1177/19322968231154561","url":null,"abstract":"<p><strong>Background: </strong>To evaluate the glycemia risk index (GRI) as a new glucometry in pediatric and adult populations with type 1 diabetes (T1D) in clinical practice.</p><p><strong>Methods: </strong>A cross-sectional study of 202 patients with T1D receiving intensive treatment with insulin (25.2% continuous subcutaneous insulin infusion [CSII]) and intermittent scanning (flash) glucose monitoring (isCGM). Clinical and glucometric isCGM data were collected, as well as the component of hypoglycemia (CHypo) and component of hyperglycemia (CHyper) of the GRI.</p><p><strong>Results: </strong>A total of 202 patients (53% males and 67.8% adults) with a mean age of 28.6 ± 15.7 years and 12.5 ± 10.9 years of T1D evolution were evaluated.Adult patients (>19 years) presented higher glycated hemoglobin (HbA1c) (7.4 ± 1.1 vs 6.7 ± 0.6%; <i>P</i> < .01) and lower time in range (TIR) (55.4 ± 17.5 vs 66.5 ± 13.1%; <i>P</i> < .01) values than the pediatric population, with lower coefficient of variation (CV) (38.6 ± 7.2 vs 42.4 ± 8.9%; <i>P</i> < .05). The GRI was significantly lower in pediatric patients (48.0 ± 22.2 vs 56.8 ± 23.4; <i>P</i> < .05) associated with higher CHypo (7.1 ± 5.1 vs 5.0 ± 4.5; <i>P</i> < .01) and lower CHyper (16.8 ± 9.8 vs 26.5 ± 15.1; <i>P</i> < .01) than in adults.When analyzing treatment with CSII compared with multiple doses of insulin (MDI), a nonsignificant trend to a lower GRI was observed in CSII (51.0 ± 15.3 vs 55.0 ± 25.4; <i>P</i>= .162), with higher levels of CHypo (6.5 ± 4.1 vs 5.4 ± 5.0; <i>P</i> < .01) and lower CHyper (19.6 ± 10.6 vs 24.6 ± 15.2; <i>P</i> < .05) compared with MDI.</p><p><strong>Conclusions: </strong>In pediatric patients and in those with CSII treatment, despite a better control by classical and GRI parameters, higher overall CHypo was observed than in adults and MDI, respectively. The present study supports the usefulness of the GRI as a new glucometric parameter to evaluate the global risk of hypoglycemia-hyperglycemia in both pediatric and adult patients with T1D.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10737683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches. 加拿大卫生部对加拿大市场上的重组人胰岛素、人胰岛素类似物和猪胰岛素药物产品中的含量进行监管核查,采用经过验证的药典方法而非非验证方法。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-01 Epub Date: 2023-03-13 DOI: 10.1177/19322968231159360
Barry Lorbetskie, Stewart Bigelow, Lisa Walrond, Agnes V Klein, Shih-Miin Loo, Nancy Green, Michael Rosu-Myles, Xu Zhang, Huixin Lu, Michel Girard, Simon Sauvé

Background: For diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic drugs, such as insulin, are complex heterogeneous products, the methods for drug product evaluation should be carefully validated for use. As such, these criteria are rigorously evaluated and monitored by national authorities. Consequently, reports that describe significantly lower insulin content than their label claims are a concern. This issue was raised by a past publication analyzing insulin drug products available in Canada, and, as a result, consumers and major patient organizations have requested clarification.

Methods: To address these concerns, this study independently analyzed insulin drug products purchased from local Canadian pharmacies-including human insulin, insulin analogs, and porcine insulin-by compendial and noncompendial reversed-phase high-performance liquid chromatography (RP-HPLC) methods.

Results: We demonstrated the importance of using methods fit for purpose when assessing insulin quality. In a preliminary screen, the expected insulin peak was seen in all products except two insulin analogs-insulin detemir and insulin degludec. Further investigation showed that this was not caused by low insulin content but insufficient solvent conditions, which demonstrated the necessity for methods to be adequately validated for product-specific use. When drug products were appropriately assessed for content using the validated type-specific compendial RP-HPLC methods for insulin quantitation, values agreed with the label claim content.

Conclusions: Because insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically.

背景:对于糖尿病治疗计划而言,胰岛素药物产品的一致性和质量对患者的健康至关重要。由于胰岛素等生物药物是复杂的异质产品,因此药物产品评估方法必须经过仔细验证才能使用。因此,国家主管机构对这些标准进行了严格的评估和监督。因此,报告中描述的胰岛素含量明显低于其标签声称的含量是一个值得关注的问题。过去一份分析加拿大胰岛素药物产品的出版物提出了这一问题,因此,消费者和主要患者组织要求对其进行澄清:为了解决这些问题,本研究采用药典和非药典反相高效液相色谱法(RP-HPLC)独立分析了从加拿大当地药店购买的胰岛素药物产品,包括人胰岛素、胰岛素类似物和猪胰岛素:结果:我们证明了在评估胰岛素质量时使用适用方法的重要性。在初步筛查中,除两种胰岛素类似物--地特米胰岛素和德谷胰岛素外,所有产品都出现了预期的胰岛素峰值。进一步的调查表明,这并不是胰岛素含量低造成的,而是溶剂条件不足造成的。当使用经过验证的特定类型药典 RP-HPLC 方法对药物产品的胰岛素含量进行适当评估时,其值与标签声称的含量一致:由于超过一百万加拿大人每天都在使用胰岛素药物产品,因此研究人员和期刊必须使用符合目的的方法提供数据,读者也必须严格评估这些报告。
{"title":"Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches.","authors":"Barry Lorbetskie, Stewart Bigelow, Lisa Walrond, Agnes V Klein, Shih-Miin Loo, Nancy Green, Michael Rosu-Myles, Xu Zhang, Huixin Lu, Michel Girard, Simon Sauvé","doi":"10.1177/19322968231159360","DOIUrl":"10.1177/19322968231159360","url":null,"abstract":"<p><strong>Background: </strong>For diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic drugs, such as insulin, are complex heterogeneous products, the methods for drug product evaluation should be carefully validated for use. As such, these criteria are rigorously evaluated and monitored by national authorities. Consequently, reports that describe significantly lower insulin content than their label claims are a concern. This issue was raised by a past publication analyzing insulin drug products available in Canada, and, as a result, consumers and major patient organizations have requested clarification.</p><p><strong>Methods: </strong>To address these concerns, this study independently analyzed insulin drug products purchased from local Canadian pharmacies-including human insulin, insulin analogs, and porcine insulin-by compendial and noncompendial reversed-phase high-performance liquid chromatography (RP-HPLC) methods.</p><p><strong>Results: </strong>We demonstrated the importance of using methods fit for purpose when assessing insulin quality. In a preliminary screen, the expected insulin peak was seen in all products except two insulin analogs-insulin detemir and insulin degludec. Further investigation showed that this was not caused by low insulin content but insufficient solvent conditions, which demonstrated the necessity for methods to be adequately validated for product-specific use. When drug products were appropriately assessed for content using the validated type-specific compendial RP-HPLC methods for insulin quantitation, values agreed with the label claim content.</p><p><strong>Conclusions: </strong>Because insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9256725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Randomized Crossover Trial Comparing Glucose Control During Postprandial Moderate Aerobic Activity and High-Intensity Interval Training in Adults With Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System. 使用先进的混合闭环系统比较 1 型糖尿病成人餐后适度有氧运动和高强度间歇训练期间的血糖控制的随机交叉试验。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-01 Epub Date: 2024-07-30 DOI: 10.1177/19322968241258444
Guliana Da Prato, Alessandro Csermely, Martina Pilati, Lorenza Carletti, Elisabetta Rinaldi, Silvia Donà, Lorenza Santi, Carlo Negri, Enzo Bonora, Paolo Moghetti, Maddalena Trombetta
{"title":"A Randomized Crossover Trial Comparing Glucose Control During Postprandial Moderate Aerobic Activity and High-Intensity Interval Training in Adults With Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System.","authors":"Guliana Da Prato, Alessandro Csermely, Martina Pilati, Lorenza Carletti, Elisabetta Rinaldi, Silvia Donà, Lorenza Santi, Carlo Negri, Enzo Bonora, Paolo Moghetti, Maddalena Trombetta","doi":"10.1177/19322968241258444","DOIUrl":"10.1177/19322968241258444","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Case Series of Use of an Automated Insulin Delivery System During Hospital Admission for Labor and Delivery. 住院分娩期间使用胰岛素自动输送系统的病例系列。
IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-09-01 Epub Date: 2024-07-23 DOI: 10.1177/19322968241266850
Matthew P Klein, Trinity L Brigham, Janet K Snell-Bergeon, Sarit Polsky
{"title":"Case Series of Use of an Automated Insulin Delivery System During Hospital Admission for Labor and Delivery.","authors":"Matthew P Klein, Trinity L Brigham, Janet K Snell-Bergeon, Sarit Polsky","doi":"10.1177/19322968241266850","DOIUrl":"10.1177/19322968241266850","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Journal of Diabetes Science and Technology
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