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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: Structured group education Behavioral: Individual education Not Applicable

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  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : March 2012
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : January 8, 2018

Resource links provided by the National Library of Medicine


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.

Individual education
Usual care (individual consultations as routinely performed)
Behavioral: Individual education
Usual care (individual consultations as routinely performed)




Primary Outcome Measures :
  1. HbA1c (between-group difference in variation from baseline) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quality of life (Well-being enquiry in Diabetics [WED] questionnaire) [ Time Frame: 12 months ]
  2. Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire) [ Time Frame: 12 months ]
  3. Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire) [ Time Frame: 12 months ]
  4. Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported) [ Time Frame: 12 months ]


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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Edoardo Mannucci, Director, Diabetology Unit, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT02443532     History of Changes
Other Study ID Numbers: DIAB120001
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases