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

A

Azienda Ospedaliero-Universitaria Careggi

Status

Terminated

Conditions

Diabetes Mellitus, Type 1

Treatments

Behavioral: Individual education
Behavioral: Structured group 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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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