Clinical Trial

Prospective Evaluation of a Dose Guidance System for People With Diabetes Initiating Basal Insulin or Using Insulin Injections

Study acronym: DGS
Recruiting
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Record status
This record was last updated May 11, 2025 (before its estimated May 25, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT06966427
Lead Sponsor Rabin Medical Center
Collaborators: DreaMed Diabetes
Conditions Type 1 Diabetes, Type 2 Diabetes
Enrollment 45 participants
Start Date 2025-05-08
Primary Completion 2026-05-25 (estimated)
Study Completion 2026-05-25 (estimated)
Updated on ClinicalTrials.gov 2025-05-11