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Sponsor: Hoffmann-La Roche
Conditions: Diabetes Mellitus, Type 1
Interventions: Accu-Chek® CONNECT DMS, DMS
Countries: United States
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.
Sex: ALL
Age: 7 Years to 18 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Phoenix, Arizona, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- Pensacola, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Idaho Falls, Idaho, United States
- Oak Lawn, Illinois, United States
- Carmel, Indiana, United States
- Saint Paul, Minnesota, United States
- Buffalo, New York, United States
- Greenville, North Carolina, United States