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NCT02609633 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Hoffmann-La Roche.

Completed
Registry status
NA
Development phase
196
Enrollment target

NCT02609633: Completed NA study, sponsored by Hoffmann-La Roche.

NCT02609633 is a NA study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 196 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02609633, a NA study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
NA
Development phase
196 participants
Enrollment target

Study 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.

Primary Outcome

The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.

Interventions

  • DEVICE Accu-Chek® CONNECT DMS
  • DEVICE DMS

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2015-12-28
Est. Completion 2017-01-20
Phase NA
Hoffmann-La Roche

909 total trials

What the finished NCT02609633 record still lists

NCT02609633 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Accu-Chek® CONNECT DMS is the first listed.

NCT02609633 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02609633 about?

NCT02609633 is a clinical study titled "Accu-Chek® CONNECT at School (CATS) Pediatric Study". 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 assign...

What is the current status of trial NCT02609633?

This trial is currently completed. It is a NA study. The enrollment target is 196 participants. The study started on 2015-12-28. Estimated completion is 2017-01-20.

What interventions are being tested in trial NCT02609633?

The interventions under investigation include: Accu-Chek® CONNECT DMS (DEVICE), DMS (DEVICE).

Who is sponsoring clinical trial NCT02609633?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02609633's enrollment target sits among peer trials

196 567th of 2000 higher than 1,434 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02609633, the US trial registry maintained by the National Library of Medicine. NCT02609633 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.