An interventional study of Teleconsultation and Standard in Type 1 Diabetes Mellitus, sponsored by Niguarda Hospital. Completed at 2 sites in Italy. Open to participants aged 5 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by Niguarda Hospital · Not applicable, Interventional, and Health services research
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 150 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Teleconsultation for patients affected by type 1 diabetes mellitus
Other: Teleconsultation
Standard visit in outpatient clinic for the same type of patients
Other: Standard
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
Group of patients followed in a traditional way
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
Time frame: 12th month
HbA1c glycosylated hemoglobin
changes of HbA1c glycosylated hemoglobin values
Time frame: 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
Time frame: 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
Time frame: 12th month
Plan to share: Undecided
The record gives a start of Jan 2015, a primary completion of Jul 2018 and a completion of Sep 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Niguarda Hospital