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Easy Diabetes Treatment Study 1

NCT03258268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2020-10-05

No results posted yet for this study

Summary

A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).

Conditions

Interventions

DEVICE

Standard of Care with EASY DSS

The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients. Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.

OTHER

Standard of Care without EASY DSS

Patients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.

Sponsors & Collaborators

  • Region Skane

    collaborator OTHER

  • Lund University

    collaborator OTHER

  • Region Halland

    collaborator OTHER

  • Västra Götalandsregionen

    collaborator OTHER

  • Läkarexpressen AB

    lead INDUSTRY

Principal Investigators

  • Damon Tojjar, MD · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-07
Primary Completion
2019-12-12
Completion
2019-12-19

Countries

  • Sweden

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 NCT03258268 on ClinicalTrials.gov