CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 153 enrolled
Drug / intervention
Usual Clinical Practice +1 morebehavioral
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/NCT02496156
NCT02496156N/ACompleted

Shared Medical Decision Making in Pediatric Diabetes

Nemours Children's Clinic·interventional·Posted Jul 14, 2015·Updated Feb 1, 2024

In Brief

A clinical study evaluating Usual Clinical Practice and Shared Medical Decision Making for Type 1 Diabetes Mellitus. Completed, enrolled 153 participants across 1 site.

Detailed Summary

This work is testing a shared medical decision making intervention for adolescents with type 1 diabetes and their parents who are candidates for adding either an insulin pump or continuous glucose monitor to their treatment plan. The first half of the work consisted of the stakeholder driven design, construction and refinement of web-delivered multimedia decision aids for each of these decisions. The randomized controlled trial of that intervention began enroling participants in February 2015. A sample of 166 eligible adolescents who receive care at an operating entity of the Nemours Children's Health System will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the Shared Medical Decision Making intervention. Primary outcomes include measures of engagement with the pertinent technology if it is chosen and measures of decision quality; Secondary outcomes include indices of metabolic control, quality of life and parent-adolescent relationships around diabetes management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 14, 2015
Enrollment StartFeb 1, 2015
Primary CompletionFeb 7, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.0 years ago

Interventions

Usual Clinical Practicebehavioral

Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.

Shared Medical Decision Makingbehavioral

Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.