NCT06966427

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Dosing Guidance System to be used with both time and amount of insulin as input	Any insulin dosing event manually logged by the participant, the DGS will receive the time and amount of the dose as input
DEVICE	Dosing Guidance System to be used with only time of insulin as input	any insulin dosing event manually logged by the participant, the DGS will receive only the time of the dose as input

Timeline

• Start date: 2025-05-08
• Primary completion: 2026-05-25
• Completion: 2026-05-25
• First posted: 2025-05-11
• Last updated: 2025-05-11

Locations

2 sites across 2 countries: Israel, Slovenia