NCT02812498

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

3.5 years

First QC Date

June 16, 2016

Last Update Submit

March 13, 2019

Conditions

Type 1 Diabetes Mellitus

Keywords

teleconsultationinsulin therapyHbA1c

Outcome Measures

Primary Outcomes (1)

  • glycosylated hemoglobin HbA1c

    HbA1c is the main parameter representing the overall glycemic control. HbA1c can be assessed on three month bases but the value at 12 month is more representative of a sustained effect of this new approach

    12th month

Secondary Outcomes (3)

  • HbA1c glycosylated hemoglobin

    3rd to 6th to 9th month

  • Patient satisfactory assessment by a questionnaire on their perception of advantages (diabetes management, comfort and convenience) and limits (technical problems, poor interaction with physicians) of the service

    12th month

  • Cost analysis by patient estimation through a questionnaire of the overall cost and time saved thanks to the service

    12th month

Study Arms (2)

Teleconsultation

EXPERIMENTAL

Teleconsultation for patients affected by type 1 diabetes mellitus

Other: Teleconsultation

Control

OTHER

Standard visit in outpatient clinic for the same type of patients

Other: Standard

Interventions

TeleconsultationOTHER

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

Teleconsultation
StandardOTHER

Group of patients followed in a traditional way

Control

Eligibility Criteria

Age5 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • without a feasible web access
  • that need a periodic physical examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AO Ospedale Civile Legnano Legnano

Legnano, 20025, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Related Publications (1)

  • 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.

    PMID: 29209814BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 24, 2016

Study Start

January 1, 2015

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

IT(2)