Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse counseling | Experimental | Phone calls performed by nurse 15 days after each monthly visit |
|
| Control | No Intervention | Normal monthly follow-up without phone calls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nurse-counselling | Behavioral | Phone calls performed by nurse 15 days after each monthly visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient's acceptance of the disease evaluated by an analogical visual scale rating | 12 months |
| Measure | Description | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc NICOLINO, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marc Nicolino | Lyon | 69005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26350209 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |