MedTrace Logo

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

NCT02443532 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-06-04

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

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)

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2018-01-08
Completion
2018-01-08

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02443532 on ClinicalTrials.gov