COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Teleconsultation in Type 1 Diabetes Mellitus (TELEDIAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02812498
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : March 15, 2019
Information provided by (Responsible Party):
Niguarda Hospital

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: Teleconsultation Other: Standard Not Applicable

Detailed Description:
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 ( 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Teleconsultation in Type 1 Diabetes Mellitus
Study Start Date : January 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Teleconsultation
Teleconsultation for patients affected by type 1 diabetes mellitus
Other: 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

Standard visit in outpatient clinic for the same type of patients
Other: Standard
Group of patients followed in a traditional way

Primary Outcome Measures :
  1. glycosylated hemoglobin HbA1c [ Time Frame: 12th month ]
    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

Secondary Outcome Measures :
  1. HbA1c glycosylated hemoglobin [ Time Frame: 3rd to 6th to 9th month ]
    changes of HbA1c glycosylated hemoglobin values

  2. 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 [ Time Frame: 12th month ]
    A score of 1 (low) to 5 (High) will be used

  3. Cost analysis by patient estimation through a questionnaire of the overall cost and time saved thanks to the service [ Time Frame: 12th month ]
    The average amount of cost and time saved will be calculated

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02812498

Layout table for location information
AO Ospedale Civile Legnano Legnano
Legnano, Italy, 20025
ASST Grande Ospedale Metropolitano Niguarda
Milano, Italy, 20162
Sponsors and Collaborators
Niguarda Hospital
Layout table for additonal information
Responsible Party: Niguarda Hospital Identifier: NCT02812498    
Other Study ID Numbers: 535-B-102014
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Niguarda Hospital:
insulin therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases