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Teleconsultation in Type 1 Diabetes Mellitus (TELEDIAB)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Teleconsultation
Standard
Sponsored by
Niguarda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes Mellitus focused on measuring teleconsultation, insulin therapy, HbA1c

Eligibility Criteria

5 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AO Ospedale Civile Legnano Legnano
  • ASST Grande Ospedale Metropolitano Niguarda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Teleconsultation

Control

Arm Description

Teleconsultation for patients affected by type 1 diabetes mellitus

Standard visit in outpatient clinic for the same type of patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c glycosylated hemoglobin
changes of HbA1c glycosylated hemoglobin values
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
A score of 1 (low) to 5 (High) will be used
Cost analysis by patient estimation through a questionnaire of the overall cost and time saved thanks to the service
The average amount of cost and time saved will be calculated

Full Information

First Posted
June 16, 2016
Last Updated
March 13, 2019
Sponsor
Niguarda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02812498
Brief Title
Teleconsultation in Type 1 Diabetes Mellitus
Acronym
TELEDIAB
Official Title
Teleconsultation in Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niguarda Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
teleconsultation, insulin therapy, HbA1c

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teleconsultation
Arm Type
Experimental
Arm Description
Teleconsultation for patients affected by type 1 diabetes mellitus
Arm Title
Control
Arm Type
Other
Arm Description
Standard visit in outpatient clinic for the same type of patients
Intervention Type
Other
Intervention Name(s)
Teleconsultation
Intervention Description
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
Intervention Name(s)
Standard
Intervention Description
Group of patients followed in a traditional way
Primary Outcome Measure Information:
Title
glycosylated hemoglobin HbA1c
Description
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
Time Frame
12th month
Secondary Outcome Measure Information:
Title
HbA1c glycosylated hemoglobin
Description
changes of HbA1c glycosylated hemoglobin values
Time Frame
3rd to 6th to 9th month
Title
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
Description
A score of 1 (low) to 5 (High) will be used
Time Frame
12th month
Title
Cost analysis by patient estimation through a questionnaire of the overall cost and time saved thanks to the service
Description
The average amount of cost and time saved will be calculated
Time Frame
12th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
AO Ospedale Civile Legnano Legnano
City
Legnano
ZIP/Postal Code
20025
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29209814
Citation
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.
Results Reference
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Teleconsultation in Type 1 Diabetes Mellitus

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