Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03177096
Other study ID # GHR 866
Secondary ID 2016-A01264-47
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2016
Est. completion date July 12, 2017

Study information

Verified date May 2018
Source Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date July 12, 2017
Est. primary completion date July 12, 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years to 13 Years
Eligibility Inclusion Criteria:

- Enrollment between September 15 to November 15, 2016

- Insulin-dependent Type 1 Diabetes with insulin pump

- From 2 to 13 years old

- Schooled to the nursery or primary school, seeing frequently a day-nursery or in an out-of-school center

- Treated at the hospital of Mulhouse, France

Exclusion Criteria:

- Opposition to study participation

- Patients who don't need sensor of measure of the continuous glycemia

Study Design


Intervention

Behavioral:
Peds QL questionnaire and diabetes modulate
Peds QL questionnaire and diabetes modulate is a pediatric questionnaire about quality of life - children's version and parents version : assessed in the 1st visit (enrollment visit) and after ten months ( V6 End of study)
WHO-5 questionnaire
WHO-5 questionnaire is a questionnaire about quality of life : assessed in the 1st visit (enrollment visit) and after ten months (V6 End of Study) by the children
Felt questionnaire
Felt questionnaire completed by parents with regard to the welcome of their child in community and by the staffs in preschool, school or in out-of school center : assessed 2 months (V2) and ten months (V6 End of study) after enrollment visit

Locations

Country Name City State
France GHRMSA Mulhouse

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

References & Publications (7)

Besbes H, Hammami S et al. SFP P-024 - Etude de la qualité de vie des enfants atteints de diabète de type 1 ; Archives de Pédiatrie Volume 21, Issue 5, Supplement 1, May 2014, Pages 734

Choudhary P, Olsen BS, Conget I, Welsh JB, Vorrink L, Shin JJ. Hypoglycemia Prevention and User Acceptance of an Insulin Pump System with Predictive Low Glucose Management. Diabetes Technol Ther. 2016 May;18(5):288-91. doi: 10.1089/dia.2015.0324. Epub 2016 Feb 23. — View Citation

Conget I, Choudhary P, Olsen BS et al. Prevention of hypoglycaemia by the predictive low glucose management feature in a user evaluation study. abstract #865

Danne T, Tsioli C, Kordonouri O, Blaesig S, Remus K, Roy A, Keenan B, Lee SW, Kaufman FR. The PILGRIM study: in silico modeling of a predictive low glucose management system and feasibility in youth with type 1 diabetes during exercise. Diabetes Technol Ther. 2014 Jun;16(6):338-47. doi: 10.1089/dia.2013.0327. Epub 2014 Jan 21. — View Citation

Institut de Veille Sanitaire. Prévalence et incidence du diabète / Données épidémiologiques / Diabète / Maladies chroniques et traumatismes / Dossiers thématiques / Accueil

Rewers MJ, Pillay K, de Beaufort C, Craig ME, Hanas R, Acerini CL, Maahs DM; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Assessment and monitoring of glycemic control in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:102-14. doi: 10.1111/pedi.12190. — View Citation

Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of Peds QL questionnaire results Questionnaire of quality of life (QL) Through study completion, an average of 10 months
Secondary Evolution of WHO-5 and felt questionnaire Questionnaire of quality of life through study completion, an average of 10 months
See also
  Status Clinical Trial Phase
Completed NCT03886974 - Transition to Adult Care in Type 1 Diabetes
Completed NCT05620251 - Response to BNT162b2 Vaccine in Adolescents With Type 1 Diabetes
Completed NCT03623113 - The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes N/A
Active, not recruiting NCT05078658 - Low-carbohydrate Diet in Children With Type 1 Diabetes N/A
Not yet recruiting NCT06018324 - CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Not yet recruiting NCT06418269 - The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes N/A
Completed NCT04172077 - Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Recruiting NCT04950634 - Sexual Dimorphism in Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
Completed NCT04450745 - Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients N/A
Completed NCT03165786 - A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes N/A
Terminated NCT04028960 - IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase Phase 2
Recruiting NCT05324488 - Diabetes Registry Graz for Biomarker Research
Completed NCT02984709 - Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes N/A
Completed NCT02984514 - Brown Adipose Tissue in Type 1 Diabetes N/A
Recruiting NCT06372392 - Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps N/A
Recruiting NCT03311516 - New Insulin Therapy by Multiwave Bolus N/A
Recruiting NCT05973799 - Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes N/A
Completed NCT03711656 - Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning Techniques N/A
Recruiting NCT05737654 - The Effect of Exercise on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life N/A