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Accu-Chek Combo in Young Patients

This study is not yet open for participant recruitment.
Verified March 2013 by Rabin Medical Center
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01657630
First received: August 2, 2012
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Type 1 Diabetes
 Device: Accu-Chek Combo System

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Diabetes Treatment Satisfaction [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires

  • Study device acceptance [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    We will assess study device acceptance using a distinct Acceptance Questionnaire


Secondary Outcome Measures:
  • Mean Blood Glucose level [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    we will compare mean blood glucose level at baseline and after 12 weeks

  • Number of Hypoglycemia Events [ Time Frame: after 12 weeks ] [ Designated as safety issue: Yes ]
    we will compare the number of hypoglycemia events at baseline and after 12 weeks

  • Number of Hyperglycemia Events [ Time Frame: after 12 weeks ] [ Designated as safety issue: Yes ]
    We will compare the number of hyperglycemia events at baseline and after 12 weeks

  • HbA1c [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    We will compare HbA1c level at baseline and after 12 weeks

  • postprandial SMBG (self monitoring blood glucose) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    We will compare between postprandial SMBG at baseline and after 12 weeks

  • Overall number of BG (Blood glucose) measurements [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    We will compare between number of BG measurements at baseline and after 12 weeks

  • Number of ketosis events [ Time Frame: after 12 weeks ] [ Designated as safety issue: Yes ]
    We will compare number of ketosis events (without documented acidosis with home/hospital management)at baseline and after 12 weeks

  • Number of Diabetic Ketoacidosis (DKA) events [ Time Frame: after 12 weeks ] [ Designated as safety issue: Yes ]
    We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks

  • preprandial SMBG (self monitoring blood glucose) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    We will compare between preprandial SMBG at baseline and after 12 weeks


Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657630

Contacts
Contact: Moshe Phillip, Prof 972-3-9253778 alonah@clalit.org.il
Contact: Alona Hamou, Msc 972-3-9253747 mosheph@clalit.org.il

Locations
Israel
Schneider Children's Medical Center Not yet recruiting
Petah-Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Hoffmann-La Roche
Investigators
Principal Investigator: Moshe Phillip, Prof Schneider Children's Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01657630     History of Changes
Other Study ID Numbers: Accu-Chek Combo
Study First Received: August 2, 2012
Last Updated: March 7, 2013
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013