NCT02097316

Brief Summary

The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

September 26, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

3 months

First QC Date

September 26, 2013

Last Update Submit

October 24, 2014

Conditions

Type 1 Diabetes

Keywords

Glycemic controlJewelPump accuracy

Outcome Measures

Primary Outcomes (1)

  • Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4

    Evaluate the non-inferiority of JewelPump compared to the usual pump patient, on glycemic control.

    up to 5 days of each treatment period

Secondary Outcomes (1)

  • Time spent in the strict glycemic area 80-140 mg / dl

    up to 5 days of each treatment period

Other Outcomes (2)

  • Time spent below 70 mg / dl

    up to 5 days in each treatment period

  • Time spent above 180mg/dl;

    up to 5 days in each treatment period

Study Arms (2)

JewelPump

EXPERIMENTAL

JewelPump for the first treatment period followed by the usual pump for the second treatment period

Device: JewelPumpDevice: usual insulin pump

Usual insulin pump

ACTIVE COMPARATOR

Patients in the arm 2, will have the usual insulin pump for the first treatment period, followed with the second period which they will have the JewelPump.

Device: JewelPumpDevice: usual insulin pump

Interventions

JewelPumpDEVICE
JewelPumpUsual insulin pump
usual insulin pumpDEVICE
JewelPumpUsual insulin pump

Eligibility Criteria

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

You may qualify if:

  • Patients type 1 diabetics treated by external insulin pump;
  • Patients with HbA1c \< 8.5%
  • Patients who signed consent

You may not qualify if:

  • Patients type 2 diabetics
  • Patients who have all serious diseases that could interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier Sud Francilien

Évry, 91000, France

Location

CHU Marseille-Hôpital Nord

Marseille, 13000, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sylvia FRANC, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

  • Nathalie JEANDIDIER, Pr.

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

  • Denis RACCAH, Pr.

    Centre Hospitalier Universitaire de Marseille

    PRINCIPAL INVESTIGATOR

  • Guillaume CHARPENTIER, MD

    Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2013

First Posted

March 27, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

FR(3)