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Effects of Nurse-Counselling in the Improvement of the type1 Diabetes Control in Adolescents
This study is currently recruiting participants.
Study NCT00308256   Information provided by Hospices Civils de Lyon
First Received: March 28, 2006   Last Updated: October 4, 2007   History of Changes

March 28, 2006
October 4, 2007
March 2006
 
Patient's acceptance of the disease evaluated by an analogical visual scale rating
Patient’s acceptance of the disease evaluated by an analogical visual scale rating
Complete list of historical versions of study NCT00308256 on ClinicalTrials.gov Archive Site
  • Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin
  • Number of diabetic acidosis having required hospitalization,
  • Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization.
Same as current
 
Effects of Nurse-Counselling in the Improvement of the type1 Diabetes Control in Adolescents
Effects of Nurse-Counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial

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

 
 
Interventional
Other, Randomized, Open Label, Uncontrolled, Parallel Assignment
Type 1 Diabetes
Behavioral: nurse-counselling
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
72
 
 

Inclusion Criteria:

  • Patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier,
  • HbA1c rate > 8 %.

Exclusion Criteria:

  • HbA1c < 8 %;
  • patients participating in another study
Both
13 Years to 18 Years
No
Contact: Marc NICOLINO, MD 33 4 72 38 56 02 marc.nicolino@chu-lyon.fr
France
 
NCT00308256
 
2005.395
Hospices Civils de Lyon
 
Principal Investigator: Marc NICOLINO, MD Hospices Civils de Lyon
Hospices Civils de Lyon
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP