Type 1 Diabetes Mellitus
Conditions
Keywords
teleconsultation, insulin therapy, HbA1c
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.
Interventions
OTHERTeleconsultation
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
OTHERStandard
Group of patients followed in a traditional way
Sponsors
Niguarda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycosylated hemoglobin HbA1c | 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c glycosylated hemoglobin | 3rd to 6th to 9th month | 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 | 12th month | 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 | 12th month | The average amount of cost and time saved will be calculated |
Countries
Italy
Outcome results
None listed