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

Type 1 Diabetes Clinical Trial

Official title:

Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308256
• Other study ID #: 2005.395
• Status: Completed
• Phase: N/A
• First received: March 28, 2006
• Last updated: December 28, 2011
• Start date: March 2006
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• nurse-counselling
Phone calls performed by nurse 15 days after each monthly visit

Locations

Country	Name	City	State
France	Marc Nicolino	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's acceptance of the disease evaluated by an analogical visual scale rating		12 months	No
Secondary	Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin		12 months	No
Secondary	Number of diabetic acidosis having required hospitalization,		12 months	No
Secondary	Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization.		12 months	No