Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00308256
Brief Summary:
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
Study:
NCT00308256
Study Brief:
Protocol Section:
NCT00308256