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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02443532
• Other study ID #: DIAB120001
• Status: Terminated
• Phase: N/A
• Start date: March 2012
• Est. completion date: January 8, 2018

Study information

• Verified date: June 2018
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: January 8, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.
• Individual education
Usual care (individual consultations as routinely performed)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c (between-group difference in variation from baseline)		12 months
Secondary	Quality of life (Well-being enquiry in Diabetics [WED] questionnaire)		12 months
Secondary	Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire)		12 months
Secondary	Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire)		12 months
Secondary	Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported)		12 months