Nov 27,2023

Safety and Efficacy of Sustained Automated Insulin Delivery Compared With Sensor and Pump Therapy in Adults With Type 1 Diabetes at High Risk for Hypoglycemia: A Randomized Controlled Trial

The objective of this study is to assess the safety and efficacy of automated insulin delivery (AID) in adults with type 1 diabetes (T1D) at high risk for hypoglycemia. Participants were 72 adults with T1D who used an insulin pump with Clarke Hypoglycemia Perception Awareness scale score >3 and/or had severe hypoglycemia during the previous 6 months confirmed by time below range of at least 5% during 2 weeks of blinded CGM. Parallel-arm, randomized trial (2:1) of AID (Tandem t:slim ×2 with Control-IQ technology) versus CGM sensor and pump therapy for 12 weeks. The primary outcome was TBR change from baseline. An optional 12-week extension with AID was offered to all participants. Compared with the sensor and pump (S&P), AID resulted in significant reduction of TBR by 3.7%; an 8.6% increase in TIR; and a 5.3% decrease in time above range. Mean sensor glucose reading remained similar in the AID and Sensor & Pump groups. These results show that in adults with T1D at high risk for hypoglycemia, AID reduced the risk for hypoglycemia more than twofold, as quantified by TBR, while improving TIR and reducing hyperglycemia.

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Nov 27,2023 TOP STORY

Automated Insulin Delivery Systems in Children and Adolescents With Type 1 Diabetes: A Systematic Review and Meta-analysis of Outpatient Randomized Controlled Trials

The glycemic control of automated insulin delivery (AID) systems in outpatient children and adolescents with type 1 diabetes (T1D) has not been systematically evaluated. To evaluate the efficacy and safety of AID systems in children and adolescents in outpatient settings, this meta analysis looks at randomized controlled trials that compared AID systems with conventional insulin therapy in outpatient children and adolescents with T1D and reported continuous glucose monitoring outcomes. Twenty-five trials (1,345 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR. The favorable effect was consistent whether AID was used over 3 months or 6 months. AID systems had a favorable effect on the proportion of time below range (TBR) compared with control treatment.

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Nov 27,2023 TOP STORY

Technological Integration Boosts Patient Engagement & Control in Diabetes: 1st of its kind, evidence-based India centric study from Roche Diabetes Care

A landmark analysis conducted by Roche Diabetes Care including approximately 40,000 people with diabetes living in India, highlights a statistically significant reduction in eHbA1c in Type II Diabetes (T2DM) when the mySugr® application was used in conjunction with a blood glucose meter. The purpose of this analysis was to describe how people with T2DM use the mySugr mobile application and to assess the impact on glycemic management using estimated HbA1c (eHbA1c) and Points In Range (PIR). The analysis found that integration enhanced patient engagement significantly, and users reported greater frequency of blood glucose monitoring, improved medication adherence, and increased overall awareness of their diabetes care. Between January 2022 and July 2023, people with T2DM used the mySugr app with 76.1% of them connecting their mySugr app to Bluetooth-enabled glucose meters like Accu-Chek® Guide and Accu-Chek® Instant. These users who connected their meters to the mySugr app were more engaged, automatically recording 90.8 blood glucose values on average, compared to 48.75 for non-connected users.

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Nov 22,2023

Lunit's AI-Powered Mammography Analysis Solution Proves Comparable to Radiologists in Breast Cancer Detection - published in European Radiology

Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced that in a study recently published in European Radiology, Lunit's AI-powered mammography analysis solution, Lunit INSIGHT MMG, has been validated for its effectiveness in standalone breast cancer detection. The research encompassed mammography screenings performed between August 4, 2014, and August 15, 2018, in the Region of Southern Denmark. It involved 249,402 screenings (149,495 women), and a total of 2,033 breast cancers. Screenings were assessed as normal or abnormal by breast radiologists through double-reading with arbitration. The study's key findings revealed that when Lunit INSIGHT MMG's cut-off score was matched at the first reader mean specificity (capacity of correctly identifying cancer-free exams), it exhibited no statistically significant difference in overall accuracy compared to that of radiologists. However, when the AI threshold was matched at the first reader mean sensitivity (capacity of correctly diagnosing cancer), it showed lower specificity (97.5% vs. 97.7%) and positive predictive value (17.5% vs. 18.7%) and a higher recall rate (3.0% vs. 2.8%) than first readers. The study findings suggest that with an appropriate cut-off score, Lunit INSIGHT MMG could feasibly replace first readers in a mammography double-reading setting. The cancers detected by AI but missed by radiologists suggest that integrating AI to support double-reading within screening could lead to an increase in the overall number of detected cancers.

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Nov 24,2023 TOP STORY

AI identifies Non-Smokers at High Risk for Lung Cancer

The United States Preventive Services Task Force (USPSTF) currently recommends lung cancer screening with low-dose CT for adults between the ages of 50 and 80 who have at least a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. One reason federal guidelines exclude never-smokers from screening recommendations is because it is difficult to predict lung cancer risk in this population. For the study, Cardiovascular Imaging Research Center (CIRC) researchers set out to improve lung cancer risk prediction in never-smokers by testing whether a deep learning model could identify never-smokers at high risk for lung cancer, based on their chest X-rays from the electronic medical record. The "CXR-Lung-Risk" model was developed using 147,497 chest X-rays of 40,643 asymptomatic smokers and never-smokers from the Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial to predict lung-related mortality risk, based on a single chest X-ray image as input. Of 17,407 patients (mean age 63 years) included in the study, 28% were deemed high risk by the deep learning model, and 2.9% of these patients later had a diagnosis of lung cancer.

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Nov 25,2023 TOP STORY

Digital health application integrating wearable data and behavioral patterns improves metabolic health

The study explores the effectiveness of the remote programfrom January AI, utilizing continuous glucose monitoring (FreeStyle Libre CGM) and wearables (HR monitor (Apple Watch or Fitbit)) to provide lifestyle recommendations for preventing Type 2 Diabetes (T2D). The program enrolled 2,217 participants with varying glucose levels over 28 days, incorporating CGM data, food intake, physical activity, and wearables information through a smartphone app. The app offered daily insights and personalized recommendations based on user preferences and observed glycemic patterns. Significant improvements in hyperglycemia, glucose variability, and hypoglycemia were observed, particularly in non-diabetic individuals. Body weight decreased across all groups, and healthy eating habits improved, indicating that integrating behavior logging, CGM data, and lifestyle recommendations through a mobile app can enhance metabolic health in both nondiabetic and T2D individuals, serving as a valuable tool for T2D prevention and treatment.

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#cgm

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Nov 21,2023

New Research Sheds Light on Mediators of Improved Outcomes in Dario Users

DarioHealth announced two new analyses recently presented by Sanofi U.S. demonstrating two mediators associated with improved clinical and economic in Dario users. Presentations by Sanofi U.S. at the Diabetes Technology Society (DTS) annual conference, held Nov. 2 – 4, examined real-world data from matched Dario users and non-users with type 2 diabetes to determine the association of medication adherence from Dario's digital health solution with blood glucose control. Dario users saw an overall clinically significant reduction in HbA1c and an associated 10.6% improvement in medication adherence. Sanofi also presented research at ISPOR Europe 2023, held on November 12-15, 2023, of a new analysis showing more frequently engaged Dario users were associated with 10% reduction in all-cause healthcare resource use over 100 days and were 15% less likely to incur related charges. Engagement was defined by activities meaningful to diabetes management, such as taking a blood glucose reading; inputting an insulin dose; recording physical activity or tagging a meal. This new analysis provides additional information from previously reported study results demonstrating Dario's ability to contribute to a reduction in all-cause healthcare utilization by 9% including inpatient hospitalizations by 23% compared to non-users at 12 months.

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Nov 21,2023

New Research Sheds Light on Mediators of Improved Outcomes in Dario Users

DarioHealth announced two new analyses recently presented by Sanofi U.S. demonstrating two mediators associated with improved clinical and economic in Dario users. Presentations by Sanofi U.S. at the Diabetes Technology Society (DTS) annual conference, held Nov. 2 – 4, examined real-world data from matched Dario users and non-users with type 2 diabetes to determine the association of medication adherence from Dario's digital health solution with blood glucose control. Dario users saw an overall clinically significant reduction in HbA1c and an associated 10.6% improvement in medication adherence. Sanofi also presented research at ISPOR Europe 2023, held on November 12-15, 2023, of a new analysis showing more frequently engaged Dario users were associated with 10% reduction in all-cause healthcare resource use over 100 days and were 15% less likely to incur related charges. Engagement was defined by activities meaningful to diabetes management, such as taking a blood glucose reading; inputting an insulin dose; recording physical activity or tagging a meal. This new analysis provides additional information from previously reported study results demonstrating Dario's ability to contribute to a reduction in all-cause healthcare utilization by 9% including inpatient hospitalizations by 23% compared to non-users at 12 months.

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#coaching

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Nov 17,2023

Researchers Take New AI Approach to Analyze Tumors

Researchers at Karolinska Institutet and SciLifeLab in Sweden have combined artificial intelligence (AI) techniques used in satellite imaging and community ecology to interpret large amounts of data from tumour tissue. The method, presented in the journal Nature Communications, could contribute to more personalised treatment of cancer patients. "We realised that the interpretation of tumour images is similar to the interpretation of satellite images and that the relationships between cells in a tissue are similar to the relationships between species in ecology," explains Jean Hausser, senior researcher at the Department of Cell and Molecular Biology, Karolinska Institutet, who led the research. "By combining techniques used in satellite imaging and ecology and adapting them for the analysis of tumour tissue, we have now been able to turn complex data into new insights into how cancer works." The next step is to apply the new method in clinical trials. The researchers are collaborating with a major cancer hospital in Lyon, France, to seek answers to why only some patients respond to cancer immunotherapy. In another collaboration with the Mayo Clinic in the US, they are investigating why some breast cancer patients don’t need chemotherapy.

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Nov 16,2023

Study finds trials of prescription DTx often lack ‘rigour’

A retrospective analysis of the clinical data supporting 20 FDA-approved prescription digital therapeutics has found that they often fail to apply rigorous standards of evidence. The researchers found 20 prescription DTx authorised for use across 22 indications, with 117 clinical studies available to support them. Of these, around 20% were observational and 38.5% were randomised controlled trials (RCTs), but more than two-thirds did not use any blinding, meaning the investigators and study subjects knew they were using the DTx. More than 60% of RCTs that were undertaken did not have the results published on the US ClinicalTrials.gov register, which could be in violation of FDA regulations. The study – published in the journal Health Affairs – concluded that just two of the FDA-approved prescription DTx that were on the market were supported by at least one randomised, blinded, and controlled trial, which is the gold standard for medicinal products. Moreover, eight (40%) of the products – which were not identified by the researchers – had no clinical trials corresponding with their FDA-approved indications.

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