Accu-Chek Combo in Young Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01657630
First received: August 2, 2012
Last updated: July 29, 2014
Last verified: April 2014

August 2, 2012
July 29, 2014
September 2012
December 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01657630 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • Pre and postprandial SMBG (self monitoring blood glucose) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    We will compare between pre and 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
Not Provided
Not Provided
 
Accu-Chek Combo in Young Patients
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

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Type 1 Diabetes
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.
Accu-Chek Combo
15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System
Intervention: Device: Accu-Chek Combo System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
6 Months to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01657630
Accu-Chek Combo
No
Rabin Medical Center
Rabin Medical Center
Hoffmann-La Roche
Principal Investigator: Moshe Phillip, Prof Schneider Children's Medical Center
Rabin Medical Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP