Accu-Chek® CONNECT at School (CATS) Pediatric Study

  • Type 1 Diabetes Mellitus
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT02609633 RD002489

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This interventional, 6-month post-marketing study is designed to evaluate the change in diabetes-related distress among parents/caregivers of school-age children and adolescents with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy. Investigational sites will be assigned using cluster randomization, with approximately 10 to 20 children at each site. In order to maintain a true control group for comparison, the investigational sites will be randomly assigned to the Accu-Chek® CONNECT Diabetes Management System (DMS) or usual care/continued use of current DMS devices.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT02609633 , RD002489 Trial Identifier
      Accu-Chek® CONNECT DMS, DMS Treatments
      Diabetes Mellitus, Type 1 Condition
      Official Title

      Accu-Chek® CONNECT at School (CATS) Pediatric Study

      Eligibility Criteria

      All Gender
      ≥ 7 Years & ≤ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Children or adolescents, aged 6 to 18 years
      • Diagnosis of T1D for at least 3 months
      • Currently managed with insulin Multiple Daily Injection (MDI) therapy
      • Attending full-day school schedule in Grade K through 12
      • Able to provide SMBG data minimum of one month prior to study start
      • Currently using a compatible Smartphone with ability to download the Accu-Chek® CONNECT System App accordingly OR ability to utilize Smartphone and Accu-Chek® CONNECT System App as provided for use in study
      • Adolescents (18 years) with diabetes provide written informed consent
      • Children 7 to 17 years to provide age-appropriate child assent
      • Parent/caregiver currently using a compatible Smartphone with ability to receive Short Message Service/Multimedia Messaging Service (SMS/MMS) messages
      • Able to read/write in English and comply with study procedures, including provision of self-monitoring blood glucose (SMBG) data at least 1 month prior to the study
      Exclusion Criteria
      • Current or planned use of continuous subcutaneous insulin infusions during the study period
      • Use of continuous glucose monitoring or a remote data-sharing system/device (i.e. NightScout, DexCom Share, Medtronic Connect) during the study
      • Pregnancy
      • Clinically significant medical condition(s) such as anemia, major organ system disease, infection, psychosis, or cognitive impairment
      • Requirement for chronic steroids, immunomodulatory medication, or chemotherapy in adrenal suppressive doses
      • Visual impairment preventing use of the Accu-Chek® CONNECT system
      • Parent/caregiver is an investigator, general practitioner, practice staff, pharmacist, research assistant, or other staff or relative of those directly involved in the study

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