Multiple Daily Injections clinical trials

Determination of Automated Multiple Insulin Dose Injections Settings Using the MDI/SMBG Advisor for Patients With Type 1 Diabetes -Data Collection, Observational & Proof of Concept Study

The MDI (Multiple Daily Injections) plus SMBG |(Self Monitoring Blood Glucose) Advisor (MPSA) is a software product that is designed to assist in insulin dosage decision making for subjects with T1DM using multiple daily injection and SMBG. The study will focus on the development, validation and eventually testing of the MPSA algorithm use. The major objective of the project is to develop an algorithm that will be able to optimize treatment plan parameters of MDI patients who use SMBG as glucose monitoring method. The clinical study has two segments. Segment A is an observational study needed for the development of the algorithm (this segment was already completed at the time of the registration) and Segment B is a proof of concept interventional study to validate the algorithm's Safety and Efficacy. Up to 20 patients using MDI and SMBG or Flash Glucose Monitoring (FGM) without using glucose trends will be enrolled to this proof of concept study. The study will evaluate the algorithm use for a period of 11 weeks. Post screening, patients will undergo a two weeks run-in period while using MDI and SMBG or FGM (patients that do not use FGM will be provided with blinded Libre Flash to be used during the run-in period and 2 weeks prior to arriving to end of study visit). Then, patients will undergo insulin treatment plan changes every week for 7 weeks. At the first 3 weeks insulin dose adjustments will be done for basal insulin dose only, week 4 will be without changes, and in the next 3 weeks the carbohydrate ratio will be amended. No recommendations will be given during the last two weeks of the study. These two weeks will be used for data analysis. Each recommendation of the Advisor will be approved by a physician before implementation. Glucose outcomes will be evaluated comparing the two weeks run-in period to the last two weeks of the study.