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

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lena Borsa

Principal Investigator

Roche Diabetes Care

Eligibility Criteria

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

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Treatment Details

Interventions

Accu-Chek® CONNECT DMS (Behavioural Intervention)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional: Accu-Chek® CONNECT DMSExperimental Treatment1 Intervention

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.

Group II: Control: Usual Care - Current Diabetes Management System (DMS)Active Control1 Intervention

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.