Status:
COMPLETED
Two Years Maintenance of Structured Group Self-management Education in Type 2 Diabetes : a Randomized Controlled Trial
Lead Sponsor:
Centre Hospitalier Universitaire de la Réunion
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical trials have clearly demonstrated that a better control of blood glucose level and of other risk factors is eff...
Detailed Description
Randomised clinical trial comparing 2 parallel arms of educational intervention with the hypothesis of the superiority of a 2-year maintenance of a structured, theoretically-based, educational follow-...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- HbA1c ≥ 7,5% more than 3 months
- Adults
- ≥ 1 year ADO and/or insulin and/or GLP-1 analog
- antidiabetic treatment unchanged since 3 months (no change of treatment in the last 3 months, except for insulin dosage)
- Living in Reunion Island
- Affiliated to French national health insurance
- Signed informed consent
Exclusion
- Treatment or associated conditions that would influence glycemic control, such as corticotherapy, cancer, inflammatory chronic diseases
- Hospitalisation linked to diabetes \< 3 months
- Structured patient education in the past 3 months
- Severe diabetes complications (e.g. ischemic or proliferative retinopathy, severe renal failure (clearance \< 15 ml/min), acute ischemic heart disease (\< 6 months, foot lesion)
- Pregnancy (on-going or planned during the study)
- Evolutive cancer
- Physical or cognitive heavy handicap
- Concomitant participation to a therapeutic trial
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01425866
Start Date
October 1 2011
End Date
September 1 2016
Last Update
January 5 2024
Active Locations (4)
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1
Groupe Hopitalier Est Réunion
Saint-Benoît, La Réunion, France, 97470
2
Centre Hospitalier Gabriel Martin
Saint-Paul, La Réunion, France, 97863
3
Diabetolgy - UNiversity Hospital Sud Réunion
Saint-Pierre, La Réunion, France, 97448
4
Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site
Saint Denis de La Réunion, France, 97405