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Completed

NCT Number: NCT02812498

Teleconsultation in Type 1 Diabetes Mellitus

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AO Ospedale Civile Legnano Legnano, Legnano, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teleconsultation

Other

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

Other

Group of patients followed in a traditional way

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Acronym: TELEDIAB

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2016
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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