Teleconsultation in Type 1 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Standard; Other: Teleconsultation

• Registration Number: NCT02812498
• Lead Sponsor: Niguarda Hospital

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Primary Completion: 2018-07
• Study Completion: 2018-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard	Standard visit in outpatient clinic for the same type of patients
Teleconsultation	Teleconsultation	Teleconsultation for patients affected by type 1 diabetes mellitus

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

AO Ospedale Civile Legnano Legnano; 🇮🇹 Legnano, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy