Bell KJ, Barclay AW, Petocz P, Colagiuri S, Brand-Miller JC Efficacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2014 Feb;2(2):133-40. doi: 10.1016/S2213-8587(13)70144-X. Epub 2013 Oct 25.
Mehta SN, Quinn N, Volkening LK, Laffel LM Impact of carbohydrate counting on glycemic control in children with type 1 diabetes. Diabetes Care. 2009 Jun;32(6):1014-6. doi: 10.2337/dc08-2068. Epub 2009 Feb 24.
Nathanson D, Svensson AM, Miftaraj M, Franzen S, Bolinder J, Eeg-Olofsson K Effect of flash glucose monitoring in adults with type 1 diabetes: a nationwide, longitudinal observational study of 14,372 flash users compared with 7691 glucose sensor naive controls. Diabetologia. 2021 Jul;64(7):1595-1603. doi: 10.1007/s00125-021-05437-z. Epub 2021 Mar 27.
Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K 10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes. Acta Diabetol. 2020 Jun;57(6):681-687. doi: 10.1007/s00592-019-01472-w. Epub 2020 Jan 17.
Petrovski G, Campbell J, Pasha M, Day E, Hussain K, Khalifa A, van den Heuvel T Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents With Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed Loop System: A Randomized Controlled Trial Comparing Glucose Control. Diabetes Care. 2023 Mar 1;46(3):544-550. doi: 10.2337/dc22-1692.
Tornese G, Carletti C, Giangreco M, Nistico D, Faleschini E, Barbi E Carbohydrate Tolerance Threshold for Unannounced Snacks in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System. Diabetes Care. 2022 Jun 2;45(6):1486-1488. doi: 10.2337/dc21-2643.
Evaluation on Glycemic Control Using Two Different Meal Announcement Plans in Adolescents With Type 1 Diabetes on Minimed 780G Hybrid Closed Loop System
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.