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Completed

NCT Number: NCT01657630

Accu-Chek Combo in Young Patients

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accu-Chek Combo System

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2012
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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