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Effects of Structured Group Education on Quality of Life and Glycemic Control in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
Quality of Life, Treatment Satisfaction, Fear of Hypoglycemia, Eating Habits, Ang Glucose Control in Patients With Type 1 Diabetes: Effects of Structured Group Education Versus Group Care.

Clinical Trial Summary

Patients with type 1 diabetes aged 15-65 years without major complications will be randomized either to usual care or to a structured group education program, with 6 four-hour weekly interactive sessions devoted to diabetes management. The principal endpoint will be the variation of HbA1c at 12 months from enrolment. Secondary endpoints will include quality of life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.

Clinical Trial Description

The group intervention consists of interactive sessions for groups of 5-7 patients, dealing with different aspects of management of type 1 diabetes: insulin therapy and hypoglycemia, management of insulin doses, diet, physical exercise, sick days, etc. The intervention is designed for the acquisition of specific skills of self-management. This intervention is provided by a team including physicians, dietitians, and nurses.

The control group will receive individual education during routine clinic visits, following usual care, complying with the recommendations of national (Italian) guidelines.

HbA1c will be assessed every three months for all the duration of the study. The principal endpoint will be variation from baseline of HbA1c at 12 weeks from the beginning of the intervention. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02443532
Study type Interventional
Source Azienda Ospedaliero-Universitaria Careggi
Contact
Status Terminated
Phase N/A
Start date March 2012
Completion date January 8, 2018
View Details
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