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

Quality of Life, Treatment Satisfaction, Fear of Hypoglycemia, Eating Habits, Ang Glucose Control in Patients With Type 1 Diabetes: Effects of Structured Group Education Versus Group Care.

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: Structured group education; Behavioral: Individual education

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Other: Individual education; Usual care (individual consultations as routinely performed)	Behavioral: Individual education; Usual care (individual consultations as routinely performed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c (between-group difference in variation from baseline)	12 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 8, 2018
• Study Completion (Actual): January 8, 2018

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): June 4, 2018
• Last Update Submitted That Met QC Criteria: June 1, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: DIAB120001