NCT01640210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
Last Updated

July 13, 2012

Status Verified

December 1, 2011

Enrollment Period

4 months

First QC Date

June 25, 2012

Last Update Submit

July 12, 2012

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • satisfaction of patients

    3 days

  • handling

    3 days

  • acceptability

    3 days

Interventions

JewelPUMP (insulin patch pump)DEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Jean Minjoz

Besançon, 25030, France

Location

University Hospital Grenoble

Grenoble, 38043, France

Location

Study Officials

  • Guillaume Charpentier, MD

    CHSF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

July 13, 2012

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 13, 2012

Record last verified: 2011-12

Locations

FR(2)