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RECRUITING
NCT06966427
NA

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

Sponsor: Rabin Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-05-08

Completion Date

2026-05-25

Last Updated

2025-05-11

Healthy Volunteers

No

Interventions

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

Locations (2)

Schneider Children Medical Center of Israel

Petah Tikva, Israel

University Medical Center of Ljubljana

Ljubljana, Slovenia