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

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ClinicalTrials.gov Identifier: NCT02443532
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : May 14, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi

May 4, 2015
May 14, 2015
June 4, 2018
March 2012
January 8, 2018   (Final data collection date for primary outcome measure)
HbA1c (between-group difference in variation from baseline) [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT02443532 on ClinicalTrials.gov Archive Site
  • Quality of life (Well-being enquiry in Diabetics [WED] questionnaire) [ Time Frame: 12 months ]
  • Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire) [ Time Frame: 12 months ]
  • Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire) [ Time Frame: 12 months ]
  • Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported) [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • 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)
  • 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.
    Intervention: Behavioral: Structured group education
  • Individual education
    Usual care (individual consultations as routinely performed)
    Intervention: Behavioral: Individual education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
250
January 8, 2018
January 8, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years to 65 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02443532
DIAB120001
No
Not Provided
Not Provided
Edoardo Mannucci, Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliero-Universitaria Careggi
Not Provided
Not Provided
Azienda Ospedaliero-Universitaria Careggi
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP