The DreaMed Endo.Digital is indicated for use by healthcare professionals treating individuals with Type 1 Diabetes (T1D) who use insulin pump or multiple daily injections (MDI) as their insulin delivery therapy and monitor their glucose levels by using Continuous Glucose Monitoring (CGM) or Flash Glucose monitoring (FGM), or SMBG above the age of 6 years old and below 30 years.
DreaMed Endo.DigitalTM is indicated for use by healthcare professionals when analyzing CGM/SMBG and pump or MDI data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, carbohydrate ratio (CR), and correction factor (CF); or MDI settings for basal rate, carbohydrate ratio (CR), and correction factor (CF) or Sliding Scale without considering the full clinical status of a particular patient. DreaMed Endo.DigitalTM does not replace clinical judgement.
The proposed study is an open label, interventional study that will include up to 500 participants with type 1 diabetes using insulin pumps or MDI therapy and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring or SMBG.
The proposed study will be 12 months, therefore will include 5 routine clinic visits.
At each visit, participants who use pump therapy will download their pump and glucose data (V1-V5) as they use to do at clinic visit. Participants who use MDI therapy will use the Endo.Digital App for insulin and glucose documentation and will upload data from their CGM/FGM or glucometer as they use to do at clinic visit.
In addition, participants will be offered to download data also at home in between study visits, every 3-6 weeks as they feel needed (Phone visits). Each time, optimization of pump settings or MDI will be done according to the downloaded data using the Endo.DigitalTM system. The device recommendations for insulin dosing adjustments and diabetes management tips will be reviewed by the treating physician. Each new treatment settings will be approved or edit by the study physician prior to implementation by the participant. At study completion, glycemic control will be evaluated by measured HbA1c and the data obtained from the participant devices and CGM/glucometer metrics, or Endo.Digital App data for MDI users.

开始日期2022-11-06

申办/合作机构

Rabin Medical Center

[+1]

NCT03774069 / WithdrawnN/AIIT

Evaluation of Remote Consultation to Patients With Type 1 Diabetes Under Continuous Glucose Sensors and Insulin Pump Therapy Using the DreaMed Advisor Pro. An Open Label, Randomized Non-inferiority Study of Insulin Pump Therapy Adjustments Between DreaMed Advisor Pro and Standard of Care-The Advisor Pro Direct Study

The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. DreaMed Advisor Pro is a decision- support software intended for assisting healthcare professionals in the management of type 1 diabetes patients who use insulin pumps as their insulin delivery therapy and monitor their blood glucose levels using CGM (Continuous Glucose Monitoring) or CGM and self-management blood glucose meter.
The main objective of the proposed study is to test the safety, reliability, and efficacy of the DreaMed Advisor Pro algorithm when the recommendation is sent directly to the patient without a physician review.
Participants will be randomized in a 1:1 ratio to either the intervention group (DreaMed Advisor Pro) or control group (standard of care). Participants will download the CGM and pump data at no less frequent than every 4 weeks for both groups during the 3 months period of the study.
Each time new data is received, the following actions will be performed:
In the intervention group, a new algorithm recommendation for pump settings will be issued. The recommendation will be approved by a technical, non-physician to assure that glucose data are not fall within predefined safety criteria which require a physician approval before the recommendation will be sent to the patient, otherwise, recommendation will be sent directly to the patient.
In the control group, if no safety criteria is met, it is the responsibility of the patient to contact his/her physician to advise on change of treatment. In case a safety issue has occurred, the physician will contact the patient and change the pump settings.
Prior to initiating the interventional phase of the study, we will evaluate the experience of patients in self adjustments of insulin dosing in regular care management and to evaluate their acceptance for using an automated dosing recommendations software. The evaluation will be done by asking patients/caregivers to fill 15 questions survey. 100 patients are anticipated to participate in this phase of the study.

开始日期2020-12-01

申办/合作机构

Rabin Medical Center

[+1]

NCT04653961 / RecruitingN/AIIT

Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies

The study comprises of two segments: a feasibility segment and a Proof of Concept segment. The study is open label, prospective study that will include up to 72 subjects in segment 1 and up to 40 subjects in segment 2. Participants are people with Type 1 or type 2 Diabetes treated with Multiple Daily Injections ( MDI) and Self Monitoring of Blood Glucose (SMBG) or intermittent Continuous Glucose Monitoring (CGM).
The study will include screening, a 2-4-week run-in period and 10-12 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps ) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 12-16 weeks.
The goal of this study is to evaluate the safety of a decision support system for adjustment of insulin treatment plan for people with diabetes using multiple daily injections and monitoring glucose by SMBG or intermittent CGM

开始日期2020-06-01

申办/合作机构

Rabin Medical Center

[+2]

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2022-08-01·Diabetes Technology & Therapeutics2区 · 医学

Comparison of Insulin Dose Adjustments Made by Artificial Intelligence-Based Decision Support Systems and by Physicians in People with Type 1 Diabetes Using Multiple Daily Injections Therapy

2区 · 医学

Article

作者: Liberty, Idit F. ; Deeb, Asma ; Christoforidis, Athanasios ; Bozzetto, Lutgarda ; Biester, Torben ; Toledano, Yoel ; Alonso, Montserrat Martín ; Nimri, Revital ; Tirosh, Amir ; Tabba, Shadi ; Giani, Elisa ; Kraljevic, Ivana ; Krcma, Michal ; Dotan, Idit ; Rabini, Rosa Anna ; Atlas, Eran ; Shtrit, Yael ; Phillip, Moshe ; Milicic, Tanja ; Bolla, Andrea Mario ; Muller, Ido ; Maltoni, Giulio ; den Brinker, Marieke ; Saboo, Banshi ; Kordonouri, Olga ; Bratina, Natasa ; Dovc, Klemen ; Gerasimidi-Vazeou, Andriani

Objective: Artificial intelligence-based decision support systems (DSS) need to provide decisions that are not inferior to those given by experts in the field. Recommended insulin dose adjustments on the same individual data set were compared among multinational physicians, and with recommendations made by automated Endo.Digital DSS (ED-DSS). Research Design and Methods: This was a noninterventional study surveying 20 physicians from multinational academic centers. The survey included 17 data cases of individuals with type 1 diabetes who are treated with multiple daily insulin injections. Participating physicians were asked to recommend insulin dose adjustments based on glucose and insulin data. Insulin dose adjustments recommendations were compared among physicians and with the automated ED-DSS. The primary endpoints were the percentage of comparison points for which there was agreement on the trend of insulin dose adjustments. Results: The proportion of agreement and disagreement in the direction of insulin dose adjustment among physicians was statistically noninferior to the proportion of agreement and disagreement observed between ED-DSS and physicians for basal rate, carbohydrate-to insulin ratio, and correction factor (P < 0.001 and P ≤ 0.004 for all three parameters for agreement and disagreement, respectively). The ED-DSS magnitude of insulin dose change was consistently lower than that proposed by the physicians. Conclusions: Recommendations for insulin dose adjustments made by automatization did not differ significantly from recommendations given by expert physicians regarding the direction of change. These results highlight the potential utilization of ED-DSS as a useful clinical tool to manage insulin titration and dose adjustments.

2022-03-01·Journal of diabetes science and technology

Adjustment of Insulin Pump Settings in Type 1 Diabetes Management: Advisor Pro Device Compared to Physicians’ Recommendations

Article

作者: Keskinen, Paivi ; Bozzetto, Lutgarda ; Smith, Lizl ; Milicic, Tanja ; Atlas, Eran ; Bolla, Andrea Mario ; den Brinker, Marieke ; Phillip, Moshe ; Christoforidis, Athanasios ; Muller, Ido ; Maltoni, Giulio ; Alonso, Montserrat Martín ; Nimri, Revital ; Tabba, Shadi ; Rabini, Rosa Anna ; Giani, Elisa ; Kraljevic, Ivana ; Oron, Tal ; Vazeou, Andriani ; Krcma, Michal ; Oren, Asaf

Aims::

To compare insulin dose adjustments made by physicians to those made by an artificial intelligence-based decision support system, the Advisor Pro, in people with type 1 diabetes (T1D) using an insulin pump and self-monitoring blood glucose (SMBG).

Methods::

This was a multinational, non-interventional study surveying 17 physicians from 11 countries. Each physician was asked to provide insulin dose adjustments for the settings of the pump including basal rate, carbohydrate-to-insulin ratios (CRs), and correction factors (CFs) for 15 data sets of pumps and SMBG of people with T1D (mean age 18.4 ± 4.8 years; eight females; mean glycated hemoglobin 8.2% ± 1.4% [66 ± 11mmol/mol]). The recommendations were compared among the physicians and between the physicians and the Advisor Pro. The study endpoint was the percentage of comparison points for which there was an agreement on the direction of insulin dose adjustments.

Results::

The percentage (mean ± SD) of agreement among the physicians on the direction of insulin pump dose adjustments was 51.8% ± 9.2%, 54.2% ± 6.4%, and 49.8% ± 11.6% for the basal, CR, and CF, respectively. The automated recommendations of the Advisor Pro on the direction of insulin dose adjustments were comparable )49.5% ± 6.4%, 55.3% ± 8.7%, and 47.6% ± 14.4% for the basal rate, CR, and CF, respectively( and noninferior to those provided by physicians. The mean absolute difference in magnitude of change between physicians was 17.1% ± 13.1%, 14.6% ± 8.4%, and 23.9% ± 18.6% for the basal, CR, and CF, respectively, and comparable to the Advisor Pro 11.7% ± 9.7%, 10.1% ± 4.5%, and 25.5% ± 19.5%, respectively, significant for basal and CR.

Conclusions::

Considerable differences in the recommendations for changes in insulin dosing were observed among physicians. Since automated recommendations by the Advisor Pro were similar to those given by physicians, it could be considered a useful tool to manage T1D.

2021-04-01·Diabetes technology & therapeutics2区 · 医学

Feasibility Study of a Hybrid Closed-Loop System with Automated Insulin Correction Boluses

2区 · 医学

Article

作者: Nir, Judith ; Nimri, Revital ; Roy, Anirban ; Atlas, Eran ; Fisch Shvalb, Naama ; Muller, Ido ; Grosman, Benyamin ; Gillon-Keren, Michal ; Kurtz, Natali ; Loewenthal, Neta ; Phillip, Moshe

Background: The Medtronic MiniMed™ 670G system adjusts basal insulin delivery in response to continuous glucose monitoring levels and is already in use in clinical practice. We tested the home-based feasibility of the new MiniMed advanced hybrid closed-loop (AHCL) system, which includes several algorithm enhancements and an optional autocorrection bolus mode. Methods: Twelve adolescents and young adults (eight females) with type 1 diabetes [median (interquartile range)] aged 16.6 (15.9, 18.2) years and diabetes duration of 7.1 (4.7, 8.8) years] participated in this single-arm study. The first stage was a 6-day open-loop run-in period, with the predictive low-glucose suspend feature on. This was followed by 6 days/5 nights in a supervised hotel setting, using the AHCL system, including closed-loop challenges (missed meal bolus, late meal bolus, and physical activity); and finally, 3 weeks with unrestricted home use. Glycemic parameters were compared between the open-loop and closed-loop periods. Results: Participants spent 93.3% (4.7) of the time in SmartGuard™ Auto Mode. Hemoglobin A1C levels decreased from median (interquartile range) 7.1% (6.7, 7.9) at baseline to 6.8% (6.6, 7.4) at study end, after 4 weeks (P = 0.0027). Time in range (TIR) (70-180 mg/dL) was 68.4% (10.6) and time below 70 mg/dL was 4% (3.5) during open-loop; and 74% (6.1) and 2.6% (1.9), respectively, during the closed-loop at home phase (P = 0.06, P = 0.27). TIR increased during the nighttime, from 64.6% (17.4) to 80.7% (7.8), P = 0.007, without change in time below 70 mg/dL (P = 0.15). No serious adverse events occurred. Conclusions: The new AHCL system demonstrated safety and effectiveness in controlling day and night glucose levels.

项与 DreaMed Diabetes Ltd. 相关的新闻（医药）

2023-11-14

·PRNewswire

The Patient's View: AI in Clinical Practice

DUBLIN , Nov. 13, 2023 /PRNewswire/ -- The "Artificial Intelligence (AI) in Clinical Practice - Patient Perspective" report has been added to ResearchAndMarkets.com's offering. A new comprehensive study, now available for consultation, focuses on understanding patient perspectives regarding the use of Artificial Intelligence (AI) in healthcare settings across multiple regions. Key Insights from the Research: Generational Gap: Younger patients showcase higher confidence in understanding AI. Human Touch: Concerns rise over the potential lack of in-person interaction with increased AI reliance. Speed and Staffing: AI is credited with faster healthcare delivery and addressing staff shortages. Familiarity Breeds Acceptance: AI-aware patients believe in its potential to elevate care quality. Administrative vs. Clinical Use: A preference for AI in administrative tasks over direct patient care is evident. Physician Experience Matters: Doctors experienced with AI are positive about its clinical decision-support capabilities. Monitoring Advancements: AI's role in enhancing existing patient monitoring solutions is acknowledged. Study Scope and Objectives: With patient surveys from a diverse demographic and condition profile, this study aims to: Gauge comfort with AI in healthcare. Analyze opinions on AI's role in treatment settings. Highlight AI's potential impact on clinical practice. Why This Study Is Crucial: Broad Base: Incorporates views from patients, professionals, KOLs, and physicians across various therapy areas. Insightful Analysis: Delivers an in-depth look at AI's current and potential applications in patient care. Key Topics Explored in the Report: Patient familiarity with AI technology. Regional analysis of concerns and perceived benefits. Comparative views of patients and healthcare professionals on AI. Use Cases Highlighted: AI Tasked with a Challenge to Identify Breast Cancer AI Helps to Organize Electronic Healthcare Records AI's Bid on Tackling and Easing NHS Pressure Revolutionizing Public Health Management with Big Data and AI AI Proves to Be Helpful in Diabetic Care A selection of companies mentioned in this report includes Brunei's Ministry of Health Cedars-Sinai DreaMed Dyad EVYD Lunit National Health Service Teton.ai US Food and Drug Administration Vantage Health For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

2023-03-20

·Business Wire

Global AI in Diabetes Management Market to 2027: Players Include Abbott, Bigfoot Biomedical, Cardinal Health, Dreamed Diabetes and Eyenuk - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "AI in Diabetes Management: Global Market Outlook" report has been added to ResearchAndMarkets.com's offering. In this report, the market has been segmented based on product type, technique and geographic region. The report provides an overview of the global market for AI in diabetes management and analyzes market trends. Using 2021 as the base year, the report provides estimated market data and revenue projections for the forecast period of 2022-2027. Market values have been estimated based on the total revenue of providers of AI in diabetes management products. The scope of the study includes AI in diabetes management care platforms and associated services. Companies Mentioned Abbott Bigfoot Biomedical Inc. Cardinal Health Inc. Dreamed Diabetes Ltd. Eyenuk Inc. Glooko Inc. Google Inc. Health Arx Technologies Private Ltd. Medtronic Virta Health Corp. Report Includes A brief general outlook of the global market for artificial intelligence (AI) in diabetic management Analyses of the global market trends, with historic market revenue for 2021, estimates for 2022, forecasts for 2023 and 2025, and projections of compound annual growth rates (CAGRs) through 2027 Understanding of the upcoming market potential for AI in diabetic mellitus management with an emphasis on new products and solutions/platform technologies, and areas of focus to forecast this market into various segments and sub-segments Estimation of the actual market size and revenue forecast for the AI in diabetic management market, and corresponding market share analysis product type, technique, and region In-depth information (facts and figures) on the major market dynamics, opportunities and gaps estimating the demand, technology adaptations in diabetes care, industry developments, regulatory dynamics, and Covid-19 impact on the progress of this market Identification of the companies best positioned to meet this demand owing to or in conjunction with their proprietary technologies, product launches, and other strategic advantages Company profiles of the major global players Diabetes management enabled by artificial intelligence (AI) is being used to detect behavioural patterns of blood sugar levels in diabetic patients. Diabetes patients' continuous glucose monitors (CGMs) collect massive amounts of previously underutilized data. The use of AI aids in the detection and prediction of diabetes. Any neglected healthcare issue can be costly for both patients and doctors. By automatically and instantly transmitting information about the pace of change and blood glucose concentrations, glucose monitors are revolutionizing the treatment of type 1 diabetes. An AI-powered glucose monitoring device automatically and instantly transmits information about the pace of change and blood glucose concentrations. These devices make use of the enormous quantity of accessible patient data to provide individualized recommendations for treatment delivery, considerably reducing the hazards associated with exogenous insulin. Self-management of diabetes has become an essential component in the treatment of the illness. By using personal data to modify their lifestyles and enable them to serve as their own at-home doctor, patients are now better able to self-manage their diabetic condition. Using AI, patients can choose what to eat or drink, as well as determine the proper amount of physical exercise. Additionally, smartphone apps such as Suguard, which analyze food calorific content in real-time, greatly simplify self-management. In this report, the global market for AI in diabetes management has been segmented based on product type, technique and geographic region. By product type, the market for AI in diabetes management is categorized into glucose monitoring devices, diagnostic devices, and insulin delivery devices. By technique, the market is categorized into case-based reasoning and intelligent data analysis. By geographic region, the market is segmented into North America, Europe, Asia-Pacific, Latin America and the Middle East and Africa. North America is currently the leading region in the global market for AI in diabetes management. Key Topics Covered: Chapter 1 Market Outlook Chapter 2 Executive Summary Chapter 3 Market Overview 3.1 Overview 3.1.1 Role of AI in Diabetes Care 3.1.2 Applications for AI in Diabetes Management 3.2 Future of AI in Diabetes Management 3.3 Market Dynamics 3.3.1 Market Drivers 3.3.2 Market Restraints 3.3.3 Market Challenges 3.4 Macroeconomic Factors of AI in Diabetes Management 3.4.1 Impact of Covid-19 Pandemic 3.4.2 Impact of Russia-Ukraine War Chapter 4 Market Opportunities 4.1 Market Opportunities 4.1.1 Growing Adoption of AI for Eye Care 4.1.2 Growing Number of Starts-Ups Targeting Diabetes Care Chapter 5 Market Breakdown by Product Type and Technique 5.1 AI in Diabetes Management Market, by Product Type 5.1.1 Glucose Monitoring Devices 5.1.2 Diagnostic Devices 5.1.3 Insulin Delivery Devices 5.2 AI in Diabetes Management Market, by Technique 5.2.1 Case-Based Reasoning 5.2.2 Intelligent Data Analysis Chapter 6 Market Breakdown by Region 6.1 Overview 6.2 North America 6.3 Europe 6.4 Asia-Pacific 6.5 Latin America 6.6 Middle East and Africa Chapter 7 Company Profiles Chapter 8 Project Scope and Methodology For more information about this report visit https://www.researchandmarkets.com/r/a5lz8r About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

2022-08-31

·PRNewswire

DreaMed partners with Billings Clinic to bring personalized expert level diabetes care to Montana's health network

Billings Clinic selects DreaMed's endo.digital AI-based clinical decision support system to help health care providers treat people with diabetes remotely across Montana BILLINGS, Montana and TEL AVIV, Israel, Aug. 31, 2022 /PRNewswire/ -- DreaMed Diabetes ("DreaMed" or the "Company"), a developer of expert-level AI-based diabetes care solutions, partners with Billings Clinic to deploy its endo.digital clinical decision support system. Through the partnership, providers in the Billings Clinic network can now access DreaMed's endo.digital platform, an FDA-cleared clinical decision support system built to aid insulin-dosing optimization for Type 1 and Type 2 diabetes patients. The United States has a national shortage of endocrinologists able to effectively manage over 34 million people living with diabetes. This problem is even more evident in rural areas of the U.S. like Montana, creating problems for patients requiring expert-level care. Despite the advances in diabetes treatment technology, the lack of access to endocrinologists and specialized care can cause great delays in receiving proper treatment and symptom management. DreaMed's AI-powered endo.digital system alleviates the challenge of personalized care distribution for both patients and doctors. DreaMed is joining forces with Billings Clinic, Montana's largest independent health care system, to help ensure people with diabetes have access to expert level care across all care settings within Billing Clinic's care delivery system. DreaMed's FDA-cleared endo.digital system turns every provider into an expert. Clinicians providing diabetes care can analyze patient data and create optimal treatment plans in seconds, enabling residents in Montana's rural areas to easily access expert level care at any care setting available, as well as remotely. Billings Clinic will initially deploy the endo.digital technology to its endocrinology clinic and will be partnering with DreaMed to expand its use into primary care and other healthcare settings. "Billings Clinic recognizes the importance of ensuring people with diabetes are reaching their glucose control goals in order to improve outcomes. Achieving this requires that all people with diabetes across Montana can access personalized expert-level care, and we are excited to begin using the endo.digital technology to help us make this a reality," says Lisa Ranes, RD, CDCES, and Manager of Diabetes, Endocrinology and Metabolism; Diabetes Research and Allergy at Billings Clinic. "Today we celebrate this partnership with Billings Clinic as another important milestone on our journey to providing personalized endocrinology care to all people with diabetes. We are excited Billings Clinic has also embraced this vision and will use our endo.digital platform to provide patients across its care delivery network access to personalized endocrinologists' recommendations based on our proprietary algorithm. We look forward to continuing to support Billings Clinic with its important mission to improve outcomes across its healthcare delivery system," says Eran Atlas, CEO at DreaMed Diabetes. About DreaMed Diabetes DreaMed Diabetes is a medical technology company providing personalized diabetes treatment optimization solutions. The company was founded out of Schneider Children's Medical Center of Israel, part of Clalit Health Services, in 2014. DreaMed commercialized its first product, an artificial pancreas technology which was licensed to Medtronic and incorporated into its 780G insulin pump technology. DreaMed is currently commercializing its endo.digital AI-based clinical decision support system for diabetes management. The endo.digital platform has FDA clearance for patients with Type 1 diabetes using continuous glucose monitors or self-monitoring blood glucose monitor devices and insulin pumps. The endo.digital technology also received expanded FDA clearance to include patients with Type 1 or Type 2 diabetes on multiple daily injections. For more information, please visit dreamed-diabetes.com or email [email protected]. About Billings Clinic Billings Clinic is Montana's largest independent health care system serving Montana, Wyoming and the western Dakotas. A not-for-profit organization led by a physician CEO, Billings Clinic is governed by a board of community members, nurses and physicians. Billings Clinic is an integrated multi-specialty group practice with a 304-bed hospital and Level II trauma center. Billings Clinic has more than 4,700 employees, including nearly 600 physicians and non-physician providers and advanced practitioners offering more than 80 specialties. Billings Clinic's vision is to be a national leader in providing the best clinical quality, patient safety, service and value. Shared electronic medical records are one way we have worked towards that goal. Contact: Jarrod Lawson, Head of Marketing DreaMed Diabetes, Inc. (862)222-7531 [email protected] SOURCE DreaMed Diabetes

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