Teleconsultation in Type 1 Diabetes Mellitus

NCT ID: NCT02812498

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the effects on glycemic control of Teleconsultation versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The growing incidence of diabetes and the need to contain health care costs empower the necessity to identify new models to cope with regular periodic follow up of patients affected by diabetes mellitus. Telemedicine offers an acknowledged instrument to provide clinical health care at a distance, increasing patient compliance and the achievement of therapeutical goals. This study wants to verify the feasibility and the efficacy of teleconsultation in patients with type 1 diabetes mellitus. In particular by a randomized controlled approach the effects on glycemic control of patients followed by teleconsultation or traditionally in standard visit in the outpatient clinic. The patients in the teleconsultation group will arrange their bookings on a website (http://www.telediabete-fid.it/) In this website they could also access to web educational courses (mainly nutrition, insulin management, glucose monitoring auto-control) or to nutritional and psychological counselling.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Teleconsultation

Teleconsultation for patients affected by type 1 diabetes mellitus

Group Type EXPERIMENTAL

Teleconsultation

Intervention Type OTHER

The patients in the consultation group arranged their bookings on a website, where they could also access to web educational courses or to nutritional and psychological counselling

Control

Standard visit in outpatient clinic for the same type of patients

Group Type OTHER

Standard

Intervention Type OTHER

Group of patients followed in a traditional way

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Teleconsultation

The patients in the consultation group arranged their bookings on a website, where they could also access to web educational courses or to nutritional and psychological counselling

Intervention Type OTHER

Standard

Group of patients followed in a traditional way

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients affected by type 1 diabetes mellitus, 5-50 years old under multi injection insulin therapy or under continuous subcutaneous insulin infusion
* with a feasible web access

Exclusion Criteria

* without a feasible web access
* that need a periodic physical examination
Minimum Eligible Age

5 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Niguarda Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AO Ospedale Civile Legnano Legnano

Legnano, , Italy

Site Status

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Bertuzzi F, Stefani I, Rivolta B, Pintaudi B, Meneghini E, Luzi L, Mazzone A. Teleconsultation in type 1 diabetes mellitus (TELEDIABE). Acta Diabetol. 2018 Feb;55(2):185-192. doi: 10.1007/s00592-017-1084-9. Epub 2017 Dec 5.

Reference Type BACKGROUND
PMID: 29209814 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

535-B-102014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Type 1 Diabetes Telemedicine
NCT03374462 COMPLETED NA
TeleCare North Diabetes
NCT06134934 ACTIVE_NOT_RECRUITING NA