Lewis D, Leibrand S; #OpenAPS Community Real-World Use of Open Source Artificial Pancreas Systems. J Diabetes Sci Technol. 2016 Nov 1;10(6):1411. doi: 10.1177/1932296816665635. Print 2016 Nov. No abstract available.
Lewis D Setting Expectations for Successful Artificial Pancreas/Hybrid Closed Loop/Automated Insulin Delivery Adoption. J Diabetes Sci Technol. 2018 Mar;12(2):533-534. doi: 10.1177/1932296817730083. Epub 2017 Sep 18. No abstract available.
Litchman ML, Lewis D, Kelly LA, Gee PM Twitter Analysis of #OpenAPS DIY Artificial Pancreas Technology Use Suggests Improved A1C and Quality of Life. J Diabetes Sci Technol. 2019 Mar;13(2):164-170. doi: 10.1177/1932296818795705. Epub 2018 Sep 10.
Observational Study to Compare Adaptions of Basal Rate Doses Using Self-build OpenAPS Artificial Pancreas Compared With Medtronic 670G Hybrid Closed Loop in Type 1 Diabetes
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
