Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03177096
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2017-06-02
Brief Title:
Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes
Sponsor:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Organization:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study Overview
Official Title:
Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes A French Monocentric Prospective Study IM-CAPT
Status:
COMPLETED
Status Verified Date:
2018-05
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:
IM-CAPT
Brief Summary:
The implementation of a sensor of glycemia Enlite coupled with an insulin pump Medtronic Minimed 640G is a therapeutic option that Hospital of Mulhouse can propose to the children affected by type 1 diabetes The glycemic rate detected by the sensor of continuous measure of the glycemia is visible in real time on the pump and then the rate can be normalized The study will evaluate the impact of the continuous measurement of blood glucose on insulin pump on child quality of life with type 1 diabetes aged 2 to 13 years old
Detailed Description:
The French High Health Authority recommends for patient with type1 diabetes a supervision of at least 4 tests a day in pre and post prandial with additional controls in circumstances of meal or of unusual physical activities
Du to age this control need supervision of an adult in each place of children life school nursery out-of-school center according to their autonomy
During several years all the actors of educational care tried to improve the welcome of the children affected by handicap or by chronic disease
Since 10 years the team of pediatric diabetology of Mulhouse Hospital has developed a partnership with the department of Education by setting up every year in September of a training courses for voluntary teachers and all staff nursery
These sessions are consisted of a formal time bringing knowledge on the disease followed by exchanges and finally a practical time around manipulation of the readers of glycemia and pumps
Alerts can be scheduled to warm an increase or an important reduction of blood glucose
The study will evaluate the child quality of life and also parents and staffs in preschool school or in out-of-school center felt too
Du to age this control need supervision of an adult in each place of children life school nursery out-of-school center according to their autonomy
During several years all the actors of educational care tried to improve the welcome of the children affected by handicap or by chronic disease
Since 10 years the team of pediatric diabetology of Mulhouse Hospital has developed a partnership with the department of Education by setting up every year in September of a training courses for voluntary teachers and all staff nursery
These sessions are consisted of a formal time bringing knowledge on the disease followed by exchanges and finally a practical time around manipulation of the readers of glycemia and pumps
Alerts can be scheduled to warm an increase or an important reduction of blood glucose
The study will evaluate the child quality of life and also parents and staffs in preschool school or in out-of-school center felt too
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A01264-47 | OTHER | Agence Nationale Sécurité du Médicament et produits de santé | None |