Teleconsultation in Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

— TELEDIAB  

Official title:

Teleconsultation in Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812498
• Other study ID #: 535-B-102014
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: September 2018

Study information

• Verified date: March 2019
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• Teleconsultation
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
Group of patients followed in a traditional way

Locations

Country	Name	City	State
Italy	AO Ospedale Civile Legnano Legnano	Legnano
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c glycosylated hemoglobin	changes of HbA1c glycosylated hemoglobin values	3rd to 6th to 9th month
Secondary	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
Secondary	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