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Accu-Chek Combo in Young Patients

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ClinicalTrials.gov Identifier: NCT01657630
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : March 12, 2015
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
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

Condition or disease Intervention/treatment
Type 1 Diabetes Device: Accu-Chek Combo System

Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Use of the Accu-Chek Combo System in Young Patients With Type 1 Diabetes
Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Diabetes Treatment Satisfaction [ Time Frame: after 12 weeks ]
    we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires

  2. Study device acceptance [ Time Frame: after 12 weeks ]
    We will assess study device acceptance using a distinct Acceptance Questionnaire


Secondary Outcome Measures :
  1. Mean Blood Glucose level [ Time Frame: after 12 weeks ]
    we will compare mean blood glucose level at baseline and after 12 weeks

  2. Number of Hypoglycemia Events [ Time Frame: after 12 weeks ]
    we will compare the number of hypoglycemia events at baseline and after 12 weeks

  3. Number of Hyperglycemia Events [ Time Frame: after 12 weeks ]
    We will compare the number of hyperglycemia events at baseline and after 12 weeks

  4. HbA1c [ Time Frame: after 12 weeks ]
    We will compare HbA1c level at baseline and after 12 weeks

  5. postprandial SMBG (self monitoring blood glucose) [ Time Frame: after 12 weeks ]
    We will compare between postprandial SMBG at baseline and after 12 weeks

  6. 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

  7. 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

  8. 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

  9. preprandial SMBG (self monitoring blood glucose) [ Time Frame: after 12 weeks ]
    We will compare between preprandial SMBG at baseline and after 12 weeks



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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657630


Locations
Israel
Schneider Children's Medical Center
Petah-Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Hoffmann-La Roche
Investigators
Principal Investigator: Moshe Phillip, Prof Schneider Children's Medical Center

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01657630     History of Changes
Other Study ID Numbers: Accu-Chek Combo
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015

Keywords provided by Rabin Medical Center:
Insulin Pump Therapy
Type 1 Diabetes
Treatment Satisfaction

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases