Clinical trial NCT01640210: Technical Evaluation Of JewelPUMP In Type 1 Diabetic Patients Treated With Extern Insulin Pump
Official title: TECHNICAL EVALUATION OF JEWELPUMP IN TYPE 1 DIABETIC PATIENTS TREATED WITH EXTERN INSULIN PUMP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2012-07-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to verify the reliability of the solutes volumes issued by the Debiotech JewelPUMPTM controlled by its remote.

Three clinical sites are participating in this study:

* CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume CHARPENTIER, Dr. Sylvia FRANC
* Grenoble University Hospital, Department of Endocrinology, Diabetes Diseases, Nutrition, GRENOBLE (38): Pr Pierre-Yves BENHAMOU
* CHU Jean Minjoz, Department of Endocrinology and Diabetology, BESANCON (25): Professor Alfred PENFORNIS, Dr. Annie CLERGEOT

The study will be conducted in 20 patients with type 1 diabetes treated by external insulin pump. Patients will be informed of the study during a screening visit. After signing the informed consent, they will return to the center where they will wear a JewelPUMPTM containing saline water, they will use their pumps in parallel. The investigator or nurse education will form the operation of the JewelPUMPTM and they will be instructed to replicate the same settings between their usual and JewelPUMPTM pump. The patient will be asked to complete visual analog scales of satisfaction with their usual treatment and the various elements of the devices (usual pump, and JewelPUMPTM) have been weighed using a precision balance to have a form of a base for comparison.

Patients will leave home for a period of about three days, but they will have to come back every days to the center. They will be asked to collect all events arising (programming problems to deliver a bolus, hardware failure ...) in a booklet.

At the end of study visit, patients will return to the center where the volumes will be assessed by the perfused weighed the various components and devices where they will complete the visual analog scales of satisfaction at endpoint.


Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetic patient treated by external insulin pump for at least 6 months
* Patient with a HbA1c \< 9%
* Patient age over 18 years of age
* Patient having signed the consent and informed form
* Patient affiliated with the social security

Exclusion Criteria:

* Patients with diabetes type 2
* Patient pregnant or likely to be
* All serious pathologies that can interfere with the study
* Incompatible psychiatric pathologies with the study

Primary outcomes:
measure: weight of the insulin pump (JewelPUMP and usual pump)
timeFrame: 3 Days
Secondary outcomes:
measure: satisfaction of patients
timeFrame: 3 days
measure: handling
timeFrame: 3 days
measure: acceptability
timeFrame: 3 days
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: CHSF
name: Guillaume Charpentier, MD
role: PRINCIPAL_INVESTIGATOR
References: