A prospective, randomized, single blind, two-arms, multicenter study. The study aims to assess the safety of a dosing-guided system (DGS) that provides direct advice on insulin dosing recommendations and diabetes management to individuals with diabetes using insulin or starting basal insulin therapy, guided by their continuous glucose monitoring (CGM).
The study population will include up to 45 individuals with diabetes, distributed as follows: 15 with Type 1 diabetes (T1D) and 15 with Type 2 diabetes (T2D), both on MDI therapy and 15 with T2D using or starting to use basal insulin.
The study will include a 2- to 4-week run-in period followed by a 6-week intervention period.
Documented T1D or T2D, for at least 6 months
Aged ≥ 6 years ≤ 75 years
HbA1c ≤ 11%
Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF)
Concomitant diseases/treatment that influence metabolic control or any significant diseases/conditions including psychiatric disorders and substance abuse or drug or alcohol abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety.
Subject has unstable or rapidly progressive renal disease or has eGFR < 45 or is receiving dialysis
Subject has active proliferative retinopathy
Active gastroparesis
Rabin Medical Center
Lead sponsor
DreaMed Diabetes
Collaborator