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

Azienda Ospedaliero-Universitaria Careggi

Status: Terminated

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Structured group education; Behavioral: Individual education

Study type: Interventional

Funder types: Other

Identifiers

NCT02443532

DIAB120001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 1 diabetes

Exclusion criteria

• serious diabetic complications, such as to interfere with physical functioning (e.g., lower limb amputation, renal failure requiring dialysis, blindness)
• Illiteracy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Structured Group education

Experimental group

Description:

Six weekly interactive group sessions of 4 hours each, providing information and developing skills for diabetes self-management, including eating habits, food composition, calculation of bolus insulin, information on physical exercise, blood glucose self-monitoring, management of hypoglycemia.

Treatment:

Behavioral: Structured group education

Individual education

Other group

Description:

Usual care (individual consultations as routinely performed)

Treatment:

Behavioral: Individual education