ArticleJournal of diabetes science and technology2019
Real-World Evidence Should Be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes.
Article in Journal of diabetes science and technology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Digital Interventions for Self-Management of Type 2 Diabetes Mellitus: Systematic Literature Review and Meta-Analysis.Journal of medical Internet research · 2024Pooled it
- Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.International journal of health policy and management · 2023Pooled it
- Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.Frontiers in medicine · 2019Pooled it
- Trial
- Digital Health Intervention on Awareness of Vaccination Against Influenza Among Adults With Diabetes: Pragmatic Randomized Follow-Up Study.Journal of medical Internet research · 2025Trial
- Advancing Public Health Through Internationally Coordinated Medical Device Registries Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review".International journal of health policy and management · 2026Article
- Glucagon-Like Peptide-1 Receptor Agonists and Peri-Procedural Aspiration Risk.Journal of the Endocrine Society · 2025Review
- Pregnancy and Diabetes Racial/Ethnicity Health Disparities in a Large Integrated Health System.Clinical diabetes : a publication of the American Diabetes Association · 2025Article
- PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan.Journal of diabetes investigation · 2024 · on this mapArticle
- Risks of peri- and postoperative complications with glucagon-like peptide-1 receptor agonists.Diabetes, obesity & metabolism · 2024Observational
- Regulatory science promotes the translation of transcatheter tricuspid valve repair/replacement devices.Regenerative biomaterials · 2024Article
- Evidence and Diabetes Technology: A Catch-22?Journal of diabetes science and technology · 2023Article
- iGlarLixi versus basal plus Rapid-Acting insulin in adults with type 2 diabetes advancing from basal insulin therapy: The SoliSimplify Real-World study.Diabetes, obesity & metabolism · 2023Article
- Six Digital Health Technologies That Will Transform Diabetes.Journal of diabetes science and technology · 2023Article
- Commercializing Personal Health Information: A Critical Qualitative Content Analysis of Documents Describing Proprietary Primary Care Databases in Canada.International journal of health policy and management · 2023Article
- Real-World Evidence of Improved Glycemic Control in People with Diabetes Using a Bluetooth-Connected Blood Glucose Meter with a Mobile Diabetes Management App.Diabetes technology & therapeutics · 2022Article
- Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300).BMJ open diabetes research & care · 2022Review
- Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers.Scientific reports · 2022Article
- Regulatory perspectives of combination products.Bioactive materials · 2022Review
- Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals.The lancet. Diabetes & endocrinology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Randomized clinical trials (RCTs) are no longer the sole source of data to inform guidelines, regulatory, and policy decisions. Real-world data (RWD), collected from registries, electronic health records, insurance claims, pharmacy records, social media, and sensor outputs from devices form real-world evidence (RWE), which can supplement evidence from RCTs. Benefits of using RWE include less time and cost to produce meaningful data; the ability to capture additional information, including social determinants of health that can impact health outcomes; detection of uncommon adverse events; and the potential to apply machine learning and artificial intelligence to the delivery of health care. Overall, combining data from RCTs and RWE would allow regulators to make ongoing and more evidence-based decisions in approving and monitoring products for diabetes.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.