Teleconsultation in Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Teleconsultation in Type 1 Diabetes Mellitus

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: Teleconsultation
* Other: Standard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teleconsultation<br>Teleconsultation for patients affected by type 1 diabetes mellitus | Other: Teleconsultation<br>* 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<br>|
| Other: Control<br>Standard visit in outpatient clinic for the same type of patients | Other: Standard<br>* Group of patients followed in a traditional way<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c glycosylated hemoglobin | changes of HbA1c glycosylated hemoglobin values | 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 | A score of 1 (low) to 5 (High) will be used | 12th month | 
| 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 | 12th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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teleconsultation, insulin therapy, HbA1c