Clinical trial NCT00308256: Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents
Official title: Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type1 diabetes;
nurse-counselling;
adolescent
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-03-29
Enrollment: 77
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility 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

Primary outcomes:
measure: Patient's acceptance of the disease evaluated by an analogical visual scale rating
timeFrame: 12 months
Secondary outcomes:
measure: Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin
timeFrame: 12 months
measure: Number of diabetic acidosis having required hospitalization,
timeFrame: 12 months
measure: Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization.
timeFrame: 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Marc Nicolino
Study officials:
affiliation: Hospices Civils de Lyon
name: Marc NICOLINO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kassai B, Rabilloud M, Bernoux D, Michal C, Riche B, Ginhoux T, Laudy V, Terral D, Didier-Wright C, Maire V, Dumont C, Cottancin G, Plasse M, Jeannoel GP, Khoury J, Bony C, Lievre M, Drai J, Nicolino M. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial. Trials. 2015 Sep 8;16:399. doi: 10.1186/s13063-015-0923-7.