CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 196 enrolled
Drug / intervention
Accu-Chek® CONNECT DMS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02609633
NCT02609633N/ACompleted
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Accu-Chek® CONNECT at School (CATS) Pediatric Study

Hoffmann-La Roche·interventional·Posted Nov 20, 2015·Updated May 18, 2018

In Brief

A clinical study evaluating Accu-Chek® CONNECT DMS and DMS for Diabetes Mellitus, Type 1. Completed, enrolled 196 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 20, 2015
Enrollment StartDec 28, 2015
Primary CompletionJan 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.6 years ago

Interventions

Accu-Chek® CONNECT DMSdevice

SMBG will be performed during the 6-month study using the Accu-Chek® Aviva CONNECT monitoring device, and corresponding Smartphone app and online tracking tool.

DMSdevice

SMBG will be performed during the 6-month study according to usual care, using the participant's current DMS (other than Accu-Chek® CONNECT DMS).