Accu-Chek Combo in Young Patients

Rabin Medical Center13 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes

Interventions

Accu-Chek Combo SystemDEVICE

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

Sex: ALLMin age: 6 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Schneider Children's Medical Center

Petah Tikva, Israel

Outcomes

Primary Outcomes

Diabetes Treatment Satisfaction

we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires

Time frame: after 12 weeks

Study device acceptance

We will assess study device acceptance using a distinct Acceptance Questionnaire

Time frame: after 12 weeks

Secondary Outcomes

Mean Blood Glucose level

we will compare mean blood glucose level at baseline and after 12 weeks

Time frame: after 12 weeks

Number of Hypoglycemia Events

we will compare the number of hypoglycemia events at baseline and after 12 weeks

Time frame: after 12 weeks

Number of Hyperglycemia Events

We will compare the number of hyperglycemia events at baseline and after 12 weeks

Time frame: after 12 weeks

HbA1c

We will compare HbA1c level at baseline and after 12 weeks

Time frame: after 12 weeks

postprandial SMBG (self monitoring blood glucose)

We will compare between postprandial SMBG at baseline and after 12 weeks

Time frame: after 12 weeks

Overall number of BG (Blood glucose) measurements

We will compare between number of BG measurements at baseline and after 12 weeks

Time frame: after 12 weeks

Data from ClinicalTrials.gov

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