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

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Structured group education; Behavioral: Individual education

• Registration Number: NCT02443532
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Primary Completion: 2018-01-08
• Study Completion: 2018-01-08
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured Group education	Structured group education	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	Individual education	Usual care (individual consultations as routinely performed)

Primary Outcome Measures

Name	Time	Method
HbA1c (between-group difference in variation from baseline)	12 months

Secondary Outcome Measures

Name	Time	Method
Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire)	12 months
Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire)	12 months
Quality of life (Well-being enquiry in Diabetics [WED] questionnaire)	12 months
Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported)	12 months