Diabetes Mellitus, Type 1
Conditions
Brief 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.
Interventions
BEHAVIORALStructured 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.
BEHAVIORALIndividual education
Usual care (individual consultations as routinely performed)
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (between-group difference in variation from baseline) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (Well-being enquiry in Diabetics [WED] questionnaire) | 12 months |
| Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire) | 12 months |
| Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire) | 12 months |
| Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported) | 12 months |
Outcome results
None listed