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Sponsored by: |
Hospices Civils de Lyon |
---|---|
Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00308256 |
The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem to need particularly a better metabolic control.
Working Hypothesis:
We hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes.
Objectives:
To show that nurse-counselling may improve levels of patient satisfaction.
Methodology:
The main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient's appreciation by 10 mm, near to "I cope very well with my diabetes".
This is a randomised parallel group study with 36 subjects in each group. During the follow-up, the "routine follow-up" group will continue its routine care. The "complementary follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months.
The total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up
Condition | Intervention |
---|---|
Type 1 Diabetes |
Behavioral: nurse-counselling |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | Effects of Nurse-Counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial |
Estimated Enrollment: | 72 |
Study Start Date: | March 2006 |
Ages Eligible for Study: | 13 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marc NICOLINO, MD | 33 4 72 38 56 02 | marc.nicolino@chu-lyon.fr |
France | |
Marc Nicolino | Recruiting |
Lyon, France, 69005 | |
Contact: Marc Nicolino, MD 33 4 72 38 56 02 marc.nicolino@chu-lyon.fr |
Principal Investigator: | Marc NICOLINO, MD | Hospices Civils de Lyon |
Study ID Numbers: | 2005.395 |
Study First Received: | March 28, 2006 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00308256 |
Health Authority: | France: Ministry of Health |
Type1 diabetes; nurse-counselling; adolescent |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |