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Teleconsultation in Type 1 Diabetes Mellitus (TELEDIAB)

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ClinicalTrials.gov Identifier: NCT02812498
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
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 (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.

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

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
Control
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



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

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 ClinicalTrials.gov identifier (NCT number): NCT02812498


Contacts
Contact: Federico Bertuzzi, MD 00396444 ext 2464 federico.bertuzzi@ospedaleniguarda.it

Locations
Italy
AO Ospedale Civile Legnano Legnano Recruiting
Legnano, Italy, 20025
Contact: Ilario Stefani, MD         
ASST Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Italy, 20162
Contact: Federico Bertuzzi, MD    0039026444 ext 2464    federico.bertuzzi@ospedaleniguarda.it   
Sponsors and Collaborators
Niguarda Hospital

Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT02812498     History of Changes
Other Study ID Numbers: 535-B-102014
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Niguarda Hospital:
teleconsultation
insulin therapy
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases