NCT02443532

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

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BEHAVIORAL	Structured group education	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.
BEHAVIORAL	Individual education	Usual care (individual consultations as routinely performed)

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-01-08
• Completion: 2018-01-08
• First posted: 2015-05-14
• Last updated: 2018-06-04