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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured Group education | Experimental | 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. |
|
| Individual education | Other | Usual care (individual consultations as routinely performed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured group education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (between-group difference in variation from baseline) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (Well-being enquiry in Diabetics [WED] questionnaire) | 12 months | |
| Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire) | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Individual education | Behavioral | Usual care (individual consultations as routinely performed) |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |