Technical Evaluation Of JewelPUMP In Type 1 Diabetic Patients Treated With Extern Insulin Pump

Type1diabetes Clinical Trial

— DIABELOOP  

Official title:

TECHNICAL EVALUATION OF JEWELPUMP IN TYPE 1 DIABETIC PATIENTS TREATED WITH EXTERN INSULIN PUMP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640210
• Other study ID #: 2011-A00666-35
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: July 12, 2012
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2011
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type1diabetes

Intervention

Device:
• JewelPUMP (insulin patch pump)
The study will be proposed during the visit of selection. Visit of inclusion: This visit will take place after having received the consent of the patient. Women will be asked to achieve a pregnancy test. Patients will wear a JewelPUMP containing saline solution in parallel with their usual insulin pump. They will be trained to use JewelPUMP. Patients treated with insulin pump will be instructed to reproduce the same "programming" between their usual pump and the JewelPUMP, they will use in parallel. Volume infused will be evaluated during a period of basal and bolus with a precision scale. Patient monitoring: Patient have to come back to the centre every 24 hours for 3 days. Study visit: Patients will be asked to fill out a questionnaire of satisfaction to the JewelPUMPTM and Visual scales. Volume infused will be evaluated with a precision scale, by comparison of weight of JewelPUMP and patients' usual pump

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besancon
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight of the insulin pump (JewelPUMP and usual pump)	accuracy of volume delivered by the JewelPUMP by comparison of the difference of weight between usual pump and JewelPUMP at Day 1, Day 2 and day 3.	3 Days	Yes
Secondary	satisfaction of patients	the satisfaction of the JewelPUMP for the patients is evaluated with visual analogic scales.; patients indicate the their satisfaction of the JewelPUMP on a scale of 10 centimeter. on the left = no satisfaction and on the right = 100% satisfaction.	3 days	No
Secondary	handling	the workability of the JewelPUMP for the patients is evaluated with visual analogic scales.; patients indicate the workability of the JewelPUMP on a scale of 10 centimeter. on the left = no workability and on the right = 100% workability.	3 days	No
Secondary	acceptability	the acceptability of the JewelPUMP for the patients is evaluated with visual analogic scales.; patients indicate the acceptability of the JewelPUMP on a scale of 10 centimeter. on the left = no acceptability and on the right = 100% acceptability.	3 days	No