Accu-Chek Combo in Young Patients

NCT ID: NCT01657630

Last Updated: 2015-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Accu-Chek Combo

15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System

Accu-Chek Combo System

Intervention Type DEVICE

12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function.

Interventions

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Accu-Chek Combo System

12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diabetes Mellitus type 1
* Continuous Subcutaneous Insulin Infusion(CSII)therapy(for at least 6 months)
* Age below 6 years
* Planned and scheduled change to a Accu-Chek Combo System within the next 3 weeks at least
* Signing on an Inform Consent Form

Exclusion Criteria

* Patient has been diagnosed with progressive/serious diseases that in judgment of the physician preclude successful completion of the observational period
* primary care giver not skilled enough to comment in a qualitative way
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moshe Phillip, Prof

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center

Locations

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Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Accu-Chek Combo

Identifier Type: -

Identifier Source: org_study_id

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