Type 1 Diabetes
Conditions
Keywords
Type1 diabetes;, nurse-counselling;, adolescent
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
Interventions
BEHAVIORALnurse-counselling
Phone calls performed by nurse 15 days after each monthly visit
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's acceptance of the disease evaluated by an analogical visual scale rating | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin | 12 months |
| Number of diabetic acidosis having required hospitalization, | 12 months |
| Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization. | 12 months |
Countries
France
Outcome results
None listed