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

NCT06966427 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-05-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • DreaMed Diabetes

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, MD · Schneider Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-08
Primary Completion
2026-05-25
Completion
2026-05-25

Countries

  • Israel
  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06966427 on ClinicalTrials.gov