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Clinical Trials/NCT02812498
NCT02812498
Completed
N/A

Teleconsultation in Type 1 Diabetes Mellitus

Niguarda Hospital2 sites in 1 country150 target enrollmentJanuary 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Niguarda Hospital
Enrollment
150
Locations
2
Primary Endpoint
glycosylated hemoglobin HbA1c
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
September 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (2)

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