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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308256
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : December 30, 2011
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


To show that nurse-counselling may improve levels of patient satisfaction.


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 or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: nurse-counselling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial
Study Start Date : March 2006
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nurse counseling
Phone calls performed by nurse 15 days after each monthly visit
Behavioral: nurse-counselling
Phone calls performed by nurse 15 days after each monthly visit
No Intervention: Control
Normal monthly follow-up without phone calls

Primary Outcome Measures :
  1. Patient's acceptance of the disease evaluated by an analogical visual scale rating [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin [ Time Frame: 12 months ]
  2. Number of diabetic acidosis having required hospitalization, [ Time Frame: 12 months ]
  3. Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308256

Marc Nicolino
Lyon, France, 69005
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Marc NICOLINO, MD Hospices Civils de Lyon

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon Identifier: NCT00308256     History of Changes
Other Study ID Numbers: 2005.395
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011

Keywords provided by Hospices Civils de Lyon:
Type1 diabetes;

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases