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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Behavioral: nurse-counselling

Study type

Interventional

Funder types

Other

Identifiers

NCT00308256
2005.395

Details and patient eligibility

About

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

Enrollment

77 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

77 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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