Study Stopped
Insufficient recruitment
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.
1 other identifier
interventional
72
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2018
CompletedJune 4, 2018
June 1, 2018
5.9 years
May 4, 2015
June 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c (between-group difference in variation from baseline)
12 months
Secondary Outcomes (4)
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
Study Arms (2)
Structured Group education
EXPERIMENTALSix 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
OTHERUsual care (individual consultations as routinely performed)
Interventions
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.
Usual care (individual consultations as routinely performed)
Eligibility Criteria
You may qualify if:
- type 1 diabetes
You may not qualify if:
- serious diabetic complications, such as to interfere with physical functioning (e.g., lower limb amputation, renal failure requiring dialysis, blindness)
- Illiteracy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Diabetology Unit
Study Record Dates
First Submitted
May 4, 2015
First Posted
May 14, 2015
Study Start
March 1, 2012
Primary Completion
January 8, 2018
Study Completion
January 8, 2018
Last Updated
June 4, 2018
Record last verified: 2018-06