Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections
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%
• For Segment 1: Using basal-bolus MDI therapy, i.e. basal insulin and a bolus that is either:
‣ Carbohydrate counting with carbohydrate ratio (CR) and correction factor (CF)
⁃ Fix dose for meal / meal estimation with CF
• For Segment 2: Using or prescribed basal insulin
• Participants using the following type of insulin as directed in the instructions for use:
‣ Basal insulin: Glargine (including Rezvoglar, Semglee, Toujeo, Soliqua), Degludec (including Tresiba U-100, Tresiba U-200, Xultophy), Determir
⁃ Bolus insulin: regular insulin, rapid analogues (Insulin Aspart, Insulin Glulisine, Insulin Lispro) or ultra-rapid analogues (Fiasp, Lyumjev)
• Participants willing to use FreesStyle Libre CGM according to manufacturer instructions, document insulin delivery, meals, and daily activities.
• Participants have a smartphone compatible with study requirements.
• Participants are willing and able to sign a written informed consent form to use their data.
• Participants are willing to use the bolus calculator for insulin dosing (only for segment 1)