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

Tracking Information

First Received Date ^ICMJE

August 2, 2012

Last Updated Date

March 7, 2013

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01657630 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Accu-Chek Combo in Young Patients

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Type 1 Diabetes

Intervention ^ICMJE

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.

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01657630

Other Study ID Numbers ^ICMJE

Accu-Chek Combo

Has Data Monitoring Committee

Responsible Party

Rabin Medical Center

Study Sponsor ^ICMJE

Rabin Medical Center

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:

Moshe Phillip, Prof

Schneider Children's Medical Center

Information Provided By

Rabin Medical Center

Verification Date

March 2013

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

To Top