Type 1 Diabetes Clinical Trial
Official title:
Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial
Verified date | December 2011 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 77 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years to 18 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Marc Nicolino | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's acceptance of the disease evaluated by an analogical visual scale rating | 12 months | No | |
Secondary | Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin | 12 months | No | |
Secondary | Number of diabetic acidosis having required hospitalization, | 12 months | No | |
Secondary | Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization. | 12 months | No |
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