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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00308256
First received: March 28, 2006
Last updated: December 28, 2011
Last verified: December 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial

Resource links provided by NLM:


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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of diabetic acidosis having required hospitalization, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: March 2006
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00308256     History of Changes
Other Study ID Numbers: 2005.395
Study First Received: March 28, 2006
Last Updated: December 28, 2011
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 17, 2014