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

Roche

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: DMS; Device: Accu-Chek® CONNECT DMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02609633

RD002489

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Control: Usual Care - Current Diabetes Management System (DMS)

Active Comparator group

Description:

Participants will perform self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device. Follow-up office visits will be scheduled at Months 3 and 6 to review and discuss SMBG data and modify the type 1 diabetes (T1D) regimen as needed.

Treatment:

Device: DMS

Interventional: Accu-Chek® CONNECT DMS

Experimental group

Description:

Participants will receive training on Day 1 with the Accu-Chek® CONNECT DMS and will thereafter perform SMBG for 6 months. Follow-up office visits will be scheduled at Months 3 and 6 to review and discuss SMBG data and modify the T1D regimen as needed.

Treatment:

Device: Accu-Chek® CONNECT DMS