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

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

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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes
• Intervention / Treatment: Device: JewelPUMP (insulin patch pump)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25030
    • Chu Jean Minjoz
  • Grenoble, France, 38043
    • University Hospital Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Investigators: Principal Investigator: Guillaume Charpentier, MD, CHSF

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (ESTIMATE): July 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 13, 2012
• Last Update Submitted That Met QC Criteria: July 12, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 2011-A00666-35