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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: nurse-counselling

• Registration Number: NCT00308256
• Lead Sponsor: 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.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-28
• Study First Submitted QC: 2006-03-28
• Study First Posted: 2006-03-29
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-28
• Last Update Posted: 2011-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse counseling	nurse-counselling	Phone calls performed by nurse 15 days after each monthly visit

Primary Outcome Measures

Name	Time	Method
Patient's acceptance of the disease evaluated by an analogical visual scale rating	12 months

Secondary Outcome Measures

Name	Time	Method
Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization.	12 months
Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin	12 months
Number of diabetic acidosis having required hospitalization,	12 months

Trial Locations

Locations (1)

Marc Nicolino; 🇫🇷 Lyon, France