Accu-Chek Combo in Young Patients

March 11, 2015 updated by: Rabin Medical Center

Evaluation of the Use of the Accu-Chek Combo System in Young Patients With Type 1 Diabetes

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah-Tikva, Israel, 49202
        • Schneider Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Young patients with type 1 Diabetes treated at the institute of Endocrinology and Diabetes, Schneider Children's Medical Center, which is a tertiary hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Accu-Chek Combo
15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diabetes Treatment Satisfaction
Time Frame: after 12 weeks
we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires
after 12 weeks
Study device acceptance
Time Frame: after 12 weeks
We will assess study device acceptance using a distinct Acceptance Questionnaire
after 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Blood Glucose level
Time Frame: after 12 weeks
we will compare mean blood glucose level at baseline and after 12 weeks
after 12 weeks
Number of Hypoglycemia Events
Time Frame: after 12 weeks
we will compare the number of hypoglycemia events at baseline and after 12 weeks
after 12 weeks
Number of Hyperglycemia Events
Time Frame: after 12 weeks
We will compare the number of hyperglycemia events at baseline and after 12 weeks
after 12 weeks
HbA1c
Time Frame: after 12 weeks
We will compare HbA1c level at baseline and after 12 weeks
after 12 weeks
postprandial SMBG (self monitoring blood glucose)
Time Frame: after 12 weeks
We will compare between postprandial SMBG at baseline and after 12 weeks
after 12 weeks
Overall number of BG (Blood glucose) measurements
Time Frame: after 12 weeks
We will compare between number of BG measurements at baseline and after 12 weeks
after 12 weeks
Number of ketosis events
Time Frame: after 12 weeks
We will compare number of ketosis events (without documented acidosis with home/hospital management)at baseline and after 12 weeks
after 12 weeks
Number of Diabetic Ketoacidosis (DKA) events
Time Frame: after 12 weeks
We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks
after 12 weeks
preprandial SMBG (self monitoring blood glucose)
Time Frame: after 12 weeks
We will compare between preprandial SMBG at baseline and after 12 weeks
after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rabin Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Accu-Chek Combo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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