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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teleconsultation | Experimental | Teleconsultation for patients affected by type 1 diabetes mellitus |
|
| Control | Other | Standard visit in outpatient clinic for the same type of patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AO Ospedale Civile Legnano Legnano | Legnano | 20025 | Italy | |||
| ASST Grande Ospedale Metropolitano Niguarda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29209814 | Background | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019114 | Remote Consultation |
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Standard | Other | Group of patients followed in a traditional way |
|
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 |
| Milan |
| 20162 |
| Italy |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |