Open-Label, Uncontrolled, Single-Arm, Single-Center, 16-Week Study Assessing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device Software in 3-Groups of Subjects With Diabetes

The purpose of the study is to determine the effectiveness and safety of the computer software program in providing insulin dosage recommendations. Participation in the study for 60 research subjects will last for 16-weeks and includes 3-4 clinic visits and a series of weekly telephone calls from the study team (minimum of 12 calls). Participants will be provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or drop off a copy of the Study Log Sheet. This information will be entered by the IDC study team into the computer software program. The IDC study team will review the information from the software and, based on the IDC's study team approval, any insulin dose changes will be communicated back to the patient by phone or fax.

开始日期2010-06-01

申办/合作机构

Health Partners Institute For Education & Research

[+4]

NCT01014832

/ CompletedN/A

An Efficacy and Safety Evaluation of Frequently Modified Intensive Insulin Therapy in Subjects With Uncontrolled Type-I or Type-2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of frequently modified intensive insulin therapy in patients with Type-2 and Type-1 diabetes mellitus.

开始日期2008-12-01

申办/合作机构

Hygieia, Inc.

[+1]

100 项与 Hygieia, Inc. 相关的临床结果

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0 项与 Hygieia, Inc. 相关的专利（医药）

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项与 Hygieia, Inc. 相关的文献（医药）

2024-08-01·Diabetes technology & therapeutics

A Scalable Application of Artificial Intelligence-Driven Insulin Titration Program to Transform Type 2 Diabetes Management

Article

作者: Warren, Mark ; Bergenstal, Richard M ; Bashan, Eran ; Hager, Matthew ; Bergenstal, Richard M. ; Hodish, Israel

Background: Despite new pharmacotherapy, most patients with long-term type 2 diabetes are still hyperglycemic. This could have been solved by insulin with its unlimited potential efficacy, but its dynamic physiology demands frequent titrations which are overdemanding. This report provides a real-life account for a scalable transformation of diabetes care in a community-based endocrinology center by harnessing artificial intelligence-based autonomous insulin titration. Methods: The center embedded the d-Nav^® technology and its dedicated clinical support. Reported outcomes include treatment efficacy/safety in the first 600 patients and use of cardiorenal-risk reduction pharmacotherapy. Findings: Patients used d-Nav for 8.2 ± 3.0 months with 82% retention. Age was 67.1 ± 11.5 years and duration of diabetes was 19.8 ± 11.0 years. During the last 3 years before d-Nav, glycated hemoglobin (HbA1c) had been overall higher than 8% and at the beginning of the program it was as high as 8.6% ± 2.1% with 29.3% of the patients with HbA1c >9%. With d-Nav, HbA1c decreased to 7.3% ± 1.2% with 5.7% of patients with HbA1c >9%. During the first 3 months, d-Nav reduced total daily dose of insulin in one of every five patients due to relatively low glucose levels to minimize the risk of hypoglycemia. Glucagon like peptide 1 (GLP-1) receptor agonists or dual GLP-1 and Glucose-dependent insulinotropic polypeptide (GIP) receptor agonists were prescribed in about a half of the patients and sodium glucose cotransporter 2 inhibitor in a third. The frequency of hypoglycemia (<54 mg/dL) was 0.4 ± 0.6/month and severe hypoglycemia 1.7/100-patient-years. Interpretation: The use of d-Nav allowed for improvement in overall diabetes management with appropriate use of both insulin and noninsulin pharmacologic agents in a scalable way.

2021-12-01·Diabetes therapy : research, treatment and education of diabetes and related disorders

Challenges in Insulin Therapy for Type 2 Diabetes

Letter

作者: Hodish, Israel

In the manuscript ''Expert Opinion: A Call for Basal Insulin Titration in Patients with Type 2 Diabetes in Daily Practice: Southeast European Perspective'', Nicolae Hancu and colleagues have devised a set of clin. guidelines to overcome the shortcoming of insulin therapy [1].I commend the group for identifying the topic as a major population health deficiency which calls for urgent solutions I would like to offer a few points for consideration.Indeed, despite insulin being available as adrug for a century, insulin therapy has been largely ineffective. Most patients with type 2 diabetes who need insulin therapy do not maintain healthy glycemic control, resulting in debilitating and, in many cases, lethal complications which are horrendously costly to treat.Unfortunately, this reality has affected not only the population of southeastern Europe, but the entire Western world [2].As the group elucidated, the main reason behind the limited success of insulin management is the lack of titrations frequent enough to overcome the dynamics of insulin requirements. Providers who typically adjust insulin doses cannot do it more than a handful times per yr, which is not nearly adequate.Yet achieving the desired glycated Hb (HbA1c) for the first time is unfortunately not enough, and frequent insulin titrations are needed at all times. My group has shown that insulin requirements do not reach a steady state. Most patients who use insulin therapy for type 2 diabetes encounter periods of considerably decreased insulin requirements (mean ± standard deviation 39.9± 12.6reduced total daily insulin) that last weeks to months and expose them to hypoglycemia.Consequently, the ability to down-titrate insulin when needed is at least as important as uptitration. Unless frequent titrations are made at all times, these unsafe periods of reduced insulin requirements are overlooked. Although long-acting insulin-only regimens for long-standing type 2 diabetes is the first insulin regimen to prescribe, most patients will not be able to maintain appropriate and safe glycemic control after about 3 years, and meal insulin boluses will be needed, as previously demonstrated in the 4 T.

2018-12-01·Clinical diabetes and endocrinology

Insulin therapy for type 2 diabetes – are we there yet? The d-Nav® story

Article

作者: Hodish, I

Insulin replacement therapy is mostly used by patients with type 2 diabetes who become insulin deficient and have failed other therapeutic options. They comprise about a quarter of those with diabetes, endures the majority of the complications and consumes the majority of the resources. Adequate insulin replacement therapy can prevent complications and reduce expenses, as long as therapy goals are achieved and maintained. Sadly, these therapy goals are seldom achieved and outcomes have not improved for decades despite advances in pharmacotherapy and technology. There is a growing recognition that the low success rate of insulin therapy results from intra-individual and inter-individual variations in insulin requirements. Total insulin requirements per day vary considerably between patients and constantly change without achieving a steady state. Thus, the key element in effective insulin therapy is unremitting and frequent dosage adjustments that can overcome those dynamics. In practice, insulin adjustments are done sporadically during outpatient clinic. Due to time constraints, providers are not able to deliver appropriate insulin dosage optimization. The d-Nav® Insulin Guidance Service has been developed to provide appropriate insulinization in insulin users without increasing the burden on healthcare systems. It relies on dedicated clinicians and a spectrum of technological solutions. Patients are provided with a handheld device called d-Nav® which advises them what dose of insulin to administer during each injection and automatically adjust insulin dosage when needed. The d-Nav care specialists periodically follow-up with users through telephone calls and in-person consultations to bestow user confidence, correct usage errors, triage, and identify uncharacteristic clinical courses. The following review provide details about the service and its clinical outcomes.

项与 Hygieia, Inc. 相关的新闻（医药）

2024-09-04

·医药观澜

完成数千万元A2轮融资，赫吉亚生物加速推进siRNA管线临床开发

9月3日，赫吉亚生物（Hygieia ）宣布已于近期完成数千万元人民币A2轮融资，由黄埔生物医药基金领投，南湾百澳基金跟投。与此同时，赫吉亚生物的A+轮融资同步进行中，计划为多个处于临床1期的管线开发补充资金，以及为后续更多IND enabling阶段项目开发提供资金支持，同时完善肝外递送平台技术的早期研发。公开信息显示，赫吉亚生物致力于siRNA领域递送技术平台的构建及药物研发。该公司建立了从靶点发现到临床概念验证的端到端siRNA药物开发平台，并聚焦当前临床急需或无药可用的疾病领域。其管线布局覆盖乙肝、NASH/MASH、心脑血管及代谢性疾病、补体介导相关疾病、神经系统疾病等。根据赫吉亚生物新闻稿，该公司已授权复星医药旗下星曜坤泽的治疗慢性乙型肝炎病毒感染的siRNA药物，已经分别获得NMPA和FDA许可进入临床试验。该药物1期临床各阶段研究结果显示了良好安全性、耐受性，以及疗效潜力。该公司开发的另一款用于治疗高脂蛋白（a）血症的管线Kylo-11，目前正处于1期临床研究阶段。该在研产品的初步临床数据显示出良好的药效与安全性，未来有望在降低心脑血管疾病风险领域发挥治疗潜力。此外，该公司的双靶向肝脏的THRβ激动剂管线Kylo-0603，可以最大限度地降低THRβ激动剂在系统的暴露量，减少对肝外脏器（如心脏和甲状腺轴）的副作用。临床前药效研究结果显示，该管线不仅可以大幅改善NAS评分及逆转肝脏纤维化，且能显著促进能量代谢。目前，该管线已完成临床1期试验的所有随访，初步结果显示健康受试者连续14天给药可达到较同类药物更显著的LDL-C降低等关键指标，且安全性和耐受性良好。参考资料： [1]赫吉亚生物完成A2轮融资快速推进多条siRNA管线的临床开发. Retrieved Sep 3， 2024, from https://mp.weixin.qq.com/s/zXToKKx3llRODS2KLd4iuA 内容来源于网络，如有侵权，请联系删除。

siRNA临床申请

2024-03-29

·医药观澜

天士力资本领投，siRNA新锐完成近亿元A1轮融资

3月28日，赫吉亚生物（Hygieia ）宣布完成近亿元A1轮融资。本轮融资由天士力资本领投，和达大健康、上海建信资本跟投，现有股东持续加注。赫吉亚生物在完成本次融资后，将加快推进公司临床阶段管线研究进展以及临床前化合物（PCCs）推向IND的进度。赫吉亚生物致力于siRNA领域递送技术平台的构建及药物研发，聚焦目前临床急需或无药可用的疾病领域，管线覆盖乙肝、NASH/MASH、心脑血管及代谢性疾病、补体介导相关疾病、神经系统疾病等。目前，赫吉亚生物已开发了多款在研产品。其中，Kylo-0603是一款双靶向肝脏、GalNAc偶联小分子THR-β激动剂，拟开发治疗中重度纤维化性非酒精性脂肪性肝炎（NASH）。该产品可以比较大限度降低THR-β激动剂在系统的暴露量，减少对肝外脏器（如心脏和甲状腺轴）的副作用。临床前药效研究结果显示，该产品不仅可以显著改善NASH，且对中重度纤维化可以达到一定程度的逆转效果。目前该产品处临床1期阶段，已完成的研究结果显示其具有良好的安全性及耐受性。 HT-101是一款针对慢性乙肝病毒感染开发的siRNA新药，由赫吉亚生物与复星医药旗下专注创新肝病治疗的公司星曜坤泽合作开发。该药已经在中国获批临床，并获美国FDA批准直接开展1b期临床。已完成的初步研究数据表明：HT-101在健康人群和慢性乙肝患者中具有良好的安全性及耐受性，并且可显著降低慢性乙肝患者乙肝表面抗原（HBsAg）。此外，赫吉亚生物基于MVIP递送技术平台开发的治疗伴有动脉粥样硬化性心血管疾病的高脂蛋白（a）血症的管线也已在中国获得临床试验默示许可。赫吉亚生物首席执行官（CEO）管涛先生表示，赫吉亚生物研发团队拥有超过20年的行业经验，多个产品已顺利进入临床转化阶段，并已有管线在人体身上得到验证。他们将持续努力，提升公司内部产品研发的标准，同时也将与更多产业同行合作，共同推动小核酸领域的进一步发展。参考资料： [1]赫吉亚生物完成近亿元A1轮融资，多条BIC潜力siRNA新药管线临床加速. Retrieved Mar 28 , 2024, from https://mp.weixin.qq.com/s/LflyPJSZOsYYkt20KbZQGQ [2]国产首个！公司授权复星旗下公司乙肝-siRNA新药获美国FDA批准直接开展1b期临床. Retrieved Sep 21 , 2023, from https://mp.weixin.qq.com/s/Iah2BxaumqhiSlTWXzNeBw 内容来源于网络，如有侵权，请联系删除。

siRNA临床申请

2023-05-04

·mobihealthnews

Billing platform Inbox Health raises $22.5M and more digital health fundings

Patient billing and communications platform Inbox Health has completed its $22.5 million Series B financing round, bringing its total raise to more than $43 million. Ten Coves Capital led the round with participation from existing investors Vertical Venture Partners, CT Innovations, Healthy Ventures, Commerce Ventures and Fairview Capital. Steven Piaker, managing partner at Ten Coves Capital, will join Inbox Health's board of directors. The company offers an AI-enabled tool that automates billing and payments. The technology was designed to give patients additional insights into their charges. Patients can pay their medical bills via text, email or paper and receive support for billing questions via text, email and live chat. The funds will be used to further the company's strategic growth. "We believe that Inbox Health's leading solution delivers tangible value to all key players in the patient care process and are excited to partner with the Inbox Health team during its next phase of growth," Piaker said in a statement. Hygieia, maker of the d-Nav Insulin Guidance Service, extended its Series B round to $22 million with a lead investment from continued investor Firstime Ventures and investments from two strategic partners. The company closed its initial $17 million Series B investment round in 2021. The d-Nav Insulin Guidance Service includes an app that recommends insulin doses for individuals with Type 2 diabetes. The app received FDA 510(k) clearance in 2019. The cloud-based service utilizes proprietary algorithms, users' blood glucose data and a small team of health professionals to generate and deliver insulin dosage recommendations. Users enter their glucose data and receive guidance for dosage directly through the company's app. Autonomize AI, an AI company for healthcare and life sciences, closed a $4 million seed round led by Asset Management Ventures. Loop Ventures, ATX Venture Partners and the Next Practices Group also participated in the round. The company offers software products like Autonomize Pixel, a clinical trial workflow platform; Autonomize Wizard, a multi-modal chart analysis offering; and Generative AI, which helps providers summarize, contextualize and visualize complex information based on internal datasets. Autonomize AI will use the funds to enhance its commercial efforts and research and development. "We believe that Autonomize AI holds the key to unlocking the vast potential of artificial intelligence in revolutionizing healthcare," Skip Fleshman, general partner at Asset Management Ventures, said in a statement. "While there is a lot of talk about AI in healthcare, extracting the insights buried within unstructured medical data in various silos is essential for fostering breakthroughs in patient care and overall health outcomes. We are thrilled to partner with this seasoned team as they lead the charge in harnessing the power of AI to create a healthier future for all."