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NCT Number: NCT00308256

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marc Nicolino

Lyon, 69005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nurse-counselling

Behavioral

Phone calls performed by nurse 15 days after each monthly visit

Primary outcomes

  1. Patient's acceptance of the disease evaluated by an analogical visual scale rating

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 29, 2006
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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