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Effects of Nurse-Counselling in the Improvement of the type1 Diabetes Control in Adolescents

This study is currently recruiting participants.
Verified by Hospices Civils de Lyon, October 2007

Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00308256
  Purpose

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

MedlinePlus related topics:   Diabetes    Diabetes Type 1   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, 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

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Patient's acceptance of the disease evaluated by an analogical visual scale rating

Secondary Outcome Measures:
  • 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.

Estimated Enrollment:   72
Study Start Date:   March 2006

  Eligibility
Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308256

Contacts
Contact: Marc NICOLINO, MD     33 4 72 38 56 02     marc.nicolino@chu-lyon.fr    

Locations
France
Marc Nicolino     Recruiting
      Lyon, France, 69005
      Contact: Marc Nicolino, MD     33 4 72 38 56 02     marc.nicolino@chu-lyon.fr    

Sponsors and Collaborators
Hospices Civils de Lyon

Investigators
Principal Investigator:     Marc NICOLINO, MD     Hospices Civils de Lyon    
  More Information


Study ID Numbers:   2005.395
First Received:   March 28, 2006
Last Updated:   October 4, 2007
ClinicalTrials.gov Identifier:   NCT00308256
Health Authority:   France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:
Type1 diabetes;  
nurse-counselling;  
adolescent  

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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