Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308256
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2006-03-28
Brief Title:
Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HbA1c7 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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None